Validation of a Tear-based Screening Assay for Breast Cancer as a Supplemental Tool to Screening Mammograms
Conditions: Healthy, Breast Cancer, Breast Cancer Female, Health Care Utilization, Health Knowledge, Attitudes, Practice, Health Personnel Attitude, Health Care Acceptability
Sponsor: Namida Lab

 
 
The VIOLA Study 
 
Validating Individualized breast cancer screening by Offering a new Link in Access 
 
Protocol Identifying Number: Pro00053749 
Principal Investigator: Anna Daily, Ph.D. 
Funded by: Namida Lab, Inc. 
Version Number: v.0.4 
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Table of Contents 
List of Abbreviations .................................................................................................................................... vi 
Statement of Compliance ........................................................................................................................... vii 
Protocol Summary ...................................................................................................................................... vii 
Schematic of Study Design ......................................................................................................................... viii 
1. Key Roles ................................................................................................................................................... 1 
2. Introduction: Background Information and Scientific Rationale .............................................................. 1 
2.1 Background Information ..................................................................................................................... 1 
2.2 Rationale ............................................................................................................................................. 5 
2.3 Potential Risks and Benefits ................................................................................................................ 6 
2.3.1 Known Potential Risks .................................................................................................................. 6 
2.3.2 Other Risks ................................................................................................................................... 6 
2.3.3 Known Potential Benefits ............................................................................................................. 6 
3. Objectives and Purpose ............................................................................................................................ 7 
3.1 Primary Objective ................................................................................................................................ 7 
3.2 Secondary Objective ........................................................................................................................... 7 
3.3 Exploratory Objective ......................................................................................................................... 7 
4. Study Design and Endpoints ..................................................................................................................... 7 
4.1 Description of the Study Design .......................................................................................................... 7 
4.2 Study Endpoints .................................................................................................................................. 8 
4.2.1 Primary Endpoint ......................................................................................................................... 8 
4.2.2 Secondary Endpoint ..................................................................................................................... 8 
4.2.3 Exploratory Endpoint ................................................................................................................... 9 
5. Study Enrollment and Withdrawal ............................................................................................................ 9 
5.1 Participant Inclusion Criteria ............................................................................................................... 9 
5.2 Participant Exclusion Criteria .............................................................................................................. 9 
5.3 Strategies for Recruitment and Retention .......................................................................................... 9 
5.4 Participant Withdrawal or Termination ............................................................................................ 10 
5.4.1 Reasons for Withdrawal or Termination.................................................................................... 10 
5.4.2 Handling of Participant Withdrawal or Termination ................................................................. 10 
5.4.3 Withdrawal Process in Mobile App ............................................................................................ 11 
5.5 Premature Termination or Suspension of Study .............................................................................. 11 
6. Study Agent ............................................................................................................................................. 11 

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6.1 Study Agent Description ................................................................................................................... 11 
6.1.1 Acquisition ................................................................................................................................. 11 
6.1.2 Formulation, Appearance, Packaging, and Labeling .................................................................. 12 
6.1.3 Product Storage and Stability .................................................................................................... 12 
6.1.4 Administration of Study Agent ................................................................................................... 12 
6.1.5 Results of Study Agent Administration ...................................................................................... 12 
6.2 Study Agent Accountability Procedures ........................................................................................... 12 
7. Study Procedures and Schedule.............................................................................................................. 13 
7.1 Study Procedures / Evaluations ........................................................................................................ 13 
7.1.1 Study Specific Procedures .......................................................................................................... 13 
7.1.2 Mobile App Eligibility and Enrollment Procedures .................................................................... 13 
7.1.3 Mobile App Consent, Baseline Demographics, and Medical History Collection ........................ 13 
7.1.4 Overall Procedures for Enrolled Participants ............................................................................. 14 
7.1.5 Standard of Care Study Procedures ........................................................................................... 14 
7.1.6 Alternatives to Study Participation without Mobile Application ............................................... 14 
7.2 Laboratory Procedures / Evaluations ................................................................................................ 15 
7.2.1 Clinical Laboratory Evaluations .................................................................................................. 15 
7.2.2 Specimen Preparation, Handling, and Storage .......................................................................... 15 
7.2.3 Specimen Shipment ................................................................................................................... 15 
7.3 Study Schedule .................................................................................................................................. 15 
7.3.1 Recruitment / Enrollment .......................................................................................................... 15 
7.3.2 Baseline Assessments / Study Intervention ............................................................................... 15 
7.3.3 Follow-Up / Final Study Visit ...................................................................................................... 16 
7.3.4 Early Termination Visit ............................................................................................................... 16 
7.3.5 Unscheduled Visit ...................................................................................................................... 16 
7.3.6 Schedule of Events Table ........................................................................................................... 16 
7.4 Concomitant Medications, Treatments, and Procedures ................................................................. 17 
8. Assessment of Safety .............................................................................................................................. 18 
8.1 Specification of Safety Parameters ................................................................................................... 18 
8.1.1 Definition of Adverse Events (AE.) ............................................................................................. 18 
8.1.2 Definition of Serious Adverse Events (SAE) ............................................................................... 18 
8.1.3 Definition of Unanticipated Problems (UP) ............................................................................... 18 
8.2 Classification of an Adverse Event .................................................................................................... 18 

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8.2.1 Severity of Event ........................................................................................................................ 18 
8.2.2 Relationship to Study Agent....................................................................................................... 19 
8.2.3 Expectedness ............................................................................................................................. 19 
8.3 Time Period and Frequency for Event Assessment and Follow-Up .................................................. 19 
8.4 Reporting Procedures ....................................................................................................................... 20 
8.4.1 Adverse Event Reporting ........................................................................................................... 20 
8.4.2 Serious Adverse Event Reporting ............................................................................................... 20 
8.4.3 Unanticipated Problem Reporting ............................................................................................. 20 
8.5 Study Halting Rules ........................................................................................................................... 21 
8.6 Safety Oversight ................................................................................................................................ 21 
9. Clinical Monitoring .................................................................................................................................. 21 
10. Statistical Considerations ...................................................................................................................... 22 
10.1 Statistical and Analytical Plans ........................................................................................................ 22 
10.2 Statistical Hypothesis ...................................................................................................................... 22 
10.3 Analysis Datasets ............................................................................................................................ 23 
10.4 Description of statistical methods .................................................................................................. 23 
10.4.1 General Approach .................................................................................................................... 23 
10.4.2 Analysis of primary efficacy endpoints .................................................................................... 23 
10.4.3 Analysis of the Secondary Endpoints ....................................................................................... 24 
10.4.5 Adherence and retention analysis ........................................................................................... 24 
11. Source Documents and Access to Source Data/Documents ................................................................ 25 
12. Quality Assurance and Quality Control ................................................................................................. 25 
12.1 Training ........................................................................................................................................... 25 
12.2 Quality Control Committee ............................................................................................................. 25 
13. Ethics/Protection of Human Subjects (Participants) ............................................................................ 25 
13.1 Ethical Standard .............................................................................................................................. 25 
13.2 Institutional Review Board .............................................................................................................. 26 
13.3 Informed Consent Process .............................................................................................................. 26 
13.3.1 Consent and Other Informational Documents Provided to Participants ................................. 26 
13.3.2 Consent Procedures and Documentation ................................................................................ 26 
13.3.3 Informed eConsent and HIPAA Authorization ......................................................................... 27 
13.4 Participant and Data Confidentiality ............................................................................................... 27 
13.4.1 Research Use of Stored Human Samples, Specimens, or Data ................................................ 28 

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13.5 Future Use of Stored Specimens ..................................................................................................... 28 
13.6 Monitoring ...................................................................................................................................... 28 
14. Data Handling and Record-Keeping ...................................................................................................... 29 
14.1 Data Collection and Management Responsibilities ........................................................................ 29 
14.2 Study Records Retention................................................................................................................. 29 
14.3 Protocol Deviations ......................................................................................................................... 30 
14.3.1 Deviation Classifications .......................................................................................................... 31 
14.4 Publication and Data Sharing Policy ............................................................................................... 31 
15. Study Administration ............................................................................................................................ 31 
15.1 Study Leadership ............................................................................................................................. 31 
16. Conflict of Interest Policy ...................................................................................................................... 31 
17. Literature References............................................................................................................................ 31 
Appendix ..................................................................................................................................................... 32 
A. Schematic of VIOLA Study Design ....................................................................................................... 32 
B. Participant Recruitment Material ....................................................................................................... 34 
C. Informed Consent Form ...................................................................................................................... 35 
D. Participant Study Enrollment Survey (Background, Demographic, Medical) ..................................... 44 
E. Tear Sample Collection: Instructions for Use (IFU) ............................................................................. 48 
F. Melody® Sample Collection Kit Instructions for Use ........................................................................... 49 
G. Namida Lab, Inc. – SOP Specimen Preparation, Handling, and Storage............................................. 51 
H. Namida Lab, Inc. CLIA Certificate of Registration ............................................................................... 54 
I. Melody® Sample Report ...................................................................................................................... 56 
J. Study Participant Exit Survey/Questionnaire ...................................................................................... 57 
K. Study Site Provider Exit Survey/Questionnaire .................................................................................. 59 
L. Namida Lab, Inc. Power Analysis (Sample Size) .................................................................................. 61 
M. Namida Lab, Inc. Privacy Policy ......................................................................................................... 64 
N. Namida Lab, Inc. Policies for PHI Use and Disclosures (HIPAA) ......................................................... 67 
O. Namida Lab, Inc. Mobile App Privacy Policy ...................................................................................... 70 
P. Namida Lab, Inc. Mobile App Cookie Policy ........................................................................................ 77 
Q. Namida Lab, Inc. Mobile App End-User License Agreement (Terms of Use) ..................................... 80 
R. Namida Lab, Inc. Mobile App Participant Facing Screenshot(s) ......................................................... 92 
 
 
 

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List of Abbreviations 
AE 
Adverse Event 
CFR 
Code of Federal Regulations 
CIOMS 
Council for International Organizations of Medical Science 
CLIA 
Clinical Laboratory Improvement Amendments 
CMP 
Clinical Monitoring Plan 
CMS 
Centers for Medicare and Medicaid Services 
CRF 
Case Report Form 
CRO 
Contract Research Organization 
DCC 
Data Coordinating Center 
DHHS 
Department of Health and Human Services 
DSMB 
Data Safety Monitoring Board 
eCRF 
Electronic Case Report Forms 
FDA 
Food and Drug Administration 
FDAAA 
Food and Drug Administration Amendments Act of 2007 
FFR 
Federal Financial Report 
GCP 
Good Clinical Practice 
GLP 
Good Laboratory Practices 
GMP 
Good Manufacturing Practices 
GWAS 
Genome-Wide Association Studies 
HIPAA 
Health Insurance Portability and Accountability Act 
IB 
Investigator’s Brochure 
ICH 
International Conference on Harmonization 
ICH E6 
International Conference on Harmonization Guidance for Industry, Good Clinical 
Practice: Consolidated Guidance 
ICMJE 
International Committee of Medical Journal Editors 
IDE 
Investigational Device Exemption 
IND 
Investigational New Drug Application 
IRB 
Investigational Review Board 
ISO 
International Organization for Standardization 
MedDRA 
Medical Dictionary for Regulatory Activities 
MOP 
Manual of Procedures 
MSDS 
Material Safety Data Sheet 
NIH 
National Institutes of Health 
NIH IC 
NIH Institute & Center 
OHRP 
Office for Human Research Protections 
PI 
Principal Investigator 
QA 
Quality Assurance 
QC 
Quality Control 
SAE 
Serious Adverse Event 
SAP 
Statistical Analysis Plan 
SMC 
Safety Monitoring Committee 
SOP 
Standard Operating Procedure 
UP 
Unanticipated Problem 
US 
United States 

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Statement of Compliance 
The VIOLA Study will be carried out in accordance with Good Clinical Practice (GCP) as required by the 
following: 
• 
US Code of Federal Regulations applicable to clinical studies (45 CFR 46) 
• 
ICH GCP E6 
• 
Completion of Human Subjects Protection Training 
Protocol Summary 
Title: Validating Individualized breast cancer screening by Offering a new Link in Access 
Short Title: The VIOLA Study 
Précis: The VIOLA Study is a Clinical Utility Study to investigate the useability of Melody®, a tear-
based screening assay for breast cancer developed and validated by Namida Lab, Inc., a 
high complexity CLIA certified lab. 
 
The VIOLA Study will have multiple study sites, with a minimum participation of 205 
women who are 40 to 74 years of age, at average risk for developing breast cancer, 
asymptomatic, and have no concerns or breast abnormalities. 
 
Melody® consists of two parts: tear sample collection and clinical lab assay. Participants 
will have a tear sample collected at a study site. The clinical lab assay, Melody®, will be 
performed at Namida Lab, Inc. The results of the Melody® assay will be returned to the site 
clinician to be discussed with the participant. 
 
Objectives: Primary Objective: Investigate the clinical utility of Melody® in federally qualified health 
centers in populations with historically low compliance rates with screening 
mammography. 
 
Secondary Objective: Assess how incorporating Melody® into a primary care provider 
setting affects participation and confidence in the current breast health continuum of care. 
 
Endpoint: Primary endpoint: The VIOLA Study is designed to quantify the relationship between two 
variables: an exposure and an outcome, by utilizing different study sites and recruiting 
from a diverse population. 
 
Secondary endpoint: Quantifying the relationship between Melody® and increased 
participation in breast health care offers the clinical utility evidence required for adoption 
into the Standard of Care. 
 
Population: Women ages 40-74 years old, at average risk for developing breast cancer 
Number of Sites: 3+ sites 
Study Agent: Melody® is a tear-based, high complexity lab-developed test. Melody® has been 
developed, validated, and will only be run by Namida Lab, Inc. as a tool in breast cancer 
screening. 
Study Duration: 6-12 months 
Participant Duration: Six months 

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Schematic of Study Design 
 
The VIOLA Study: Validating Individualized breast cancer screening 
by Offering a new Link in Access 
 
Recruit and consent study sites 
Establish study site principal investigator and study agreement consent 
On-board and train study site personnel 
Define study site opportunity/channels for study participant recruitment 
Create study site materials from approved IRB submission 
Total participants (205 minimum) 
Recruit potential participants by inclusion/exclusion criteria 
Participant downloads the Namida Lab, Inc. mobile app if they have access to a device 
Obtain informed consent from the study participant 
Obtain participant's history/demographics from surveys/questionnaires 
Sample Collection – Site-specific: Sample may be collected as a walk-in or scheduled appointment 
Study participant tear sample sent to Namida Lab, Inc. 
Namida Lab, Inc. conducts Melody® assay on participant samples 
Namida Lab, Inc. returns Melody® assay results to the study site investigator/clinician/personnel 
Study site clinician and Namida Lab, Inc. review Melody® assay results, if requested 
Study site clinician and study participant review Melody® assay results 
Study participant completes exit survey/questionnaire 
Study site personnel completes exit survey/questionnaire 
Namida Lab, Inc. distributes compensation to study participants 
Ongoing data analysis at Namida Lab, Inc. 
Namida Lab, Inc. completes all data analysis from study site personnel and participants 
Namida Lab, Inc. closes sites/study 
*Appendix A: Visual Diagram of Study Schematic
Study Design/Site Enrollment 
Define – Month 1-6 
Participant Recruitment/Enrollment (Study Intervention) 
Measure – Month 5-11 
Baseline Assessments/Study Intervention 
Analyze – Month 5-11 
Follow-Up (Assessments of Study Endpoints/Safety) 
Improve – Month 5-11 
End of Study Assessment 
Control – Month 12 

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1. Key Roles
Anna Daily, Ph.D. 
VP of Product Development & Innovation 
Principal Investigator 
Namida Lab, Inc. 
1905 E Mission Blvd, Ste 6 
Fayetteville, AR 72703 
479.334.2828 
anna@namidalab.com 
Shelby VanHoutan, MBA 
Clinical Research Coordinator 
Namida Lab, Inc. 
1905 E Mission Blvd, Ste 6 
Fayetteville, AR 72703 
479.334.2828 
shelby@namidalab.com 
2. Introduction: Background Information and Scientific Rationale 
2.1 Background Information 
Determining the Sensitivity and Specificity of the Melody® assay 
 
 
Analysis of the development data set was 
outsourced to the statistical firm Elite Research, 
Irvine, TX, to develop an algorithm and scoring 
system by which samples could be classified. 
Stepwise linear regression analysis of the 
development data set (224 healthy controls and 45 
confirmed breast cancer samples) was used to 
determine relevant covariates and produce a 
screening algorithm and scoring system. The 
coordinates of the ROC curve were used to select a 
diagnostic threshold of 0.1.  
 
 
 
 A smaller validation sample set (167 healthy 
controls and 15 breast cancer samples) was used 
to test the algorithm and diagnostic cutoff, 
followed by clinical validation of Melody® in the 
CLIA lab with 50 healthy control samples and 50 
breast cancer samples.   
 
 
False-positive and false-negative rates were determined strictly based on Melody® classification, 
not score. Tear samples were collected at the time of imaging procedures, tested at Namida Lab, 
Inc., and assigned a score and classification before confirming the final diagnosis from our clinical 
partner. Once received, the final diagnosis was then compared to the classification of High or Low 
determined through the Melody® algorithm. 
 
Patients who were given a Low Melody® classification but tested positive for breast cancer were 
ROC curve for Breast Cancer vs. Healthy Controls.  

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considered false negatives. This occurred for 8% of samples. Patients were given a High Melody® 
classification, but no area of concern or suspicion was detected on their mammogram classified 
as false positive. This occurred in 46% of samples.  
 
A standard screening population would typically be entering the continuum of care for a 
screening mammogram and would fall between the ages of 40-70. All healthy controls were 
collected at the time of the screening mammogram. Breast cancer samples were typically 
collected at the time of biopsy or diagnostic MRI. Previous imaging procedures were provided by 
clinical partners when providing diagnostic information. 
 
Eighty-four percent of the breast cancer samples were collected from women entering the 
continuum of care at screening mammograms. Approximately five percent of breast cancer 
samples did not have any screening and were initially seen due to an area of concern. Sample 
collection for these individuals occurred at biopsy or diagnostic MRI. Screening procedures were 
not recorded for eight percent of breast cancer samples of the population. 
  
Age distribution of the entire patient population was as expected, with 85% of our samples falling 
within the normal screening age range of 40-70. Specifically: 
• 
2% were < 39 years of age, 
• 
30% were 40-49 years of age, 
• 
25% were 50-59 years of age, 
• 
30% were 60-69 years of age, 
• 
13% were >70 years of age.  
 
The VIOLA Study is a Clinical Utility Study to investigate the useability of Melody®, a tear-based 
screening assay for breast cancer. Melody® was developed and validated by Namida Lab, Inc., a 
high complexity Clinical Laboratory Improvement Amendments (CLIA) certified lab.  
 
Key terms 
• 
The Clinical Laboratory Improvement Amendment (CLIA) passed in 1988 was established 
to provide quality standards, strengthen federal oversight of clinical laboratories, and 
ensure the reliability and accuracy of patient test results. This program allows clinical labs 
to develop and validate their testing protocols which can only be run in the lab where the 
protocol was validated.  
• 
Namida Lab, Inc. is a CLIA certified high complexity lab. (Appendix H) 
• 
The FDA is responsible for developing and assigning CLIA test complexity categorization 
rules and guidance.  
• 
Melody® is a high complexity lab-developed test that has been developed and validated 
by Namida Lab, Inc. and will be run only by Namida Lab, Inc.  
• 
A clinical utility study evaluates the usefulness, benefits, and drawbacks of an 
intervention (1).  
 
What is the Validation process for an LDT? 
Requirements for validation of a lab-developed test are clearly outlined by CLIA (2). 
• 
In short, each assay must meet guidelines for precision, accuracy, sensitivity, and 
specificity (both analytical and clinical), linearity, and assay range. 
• 
Each laboratory drafts an umbrella Standard Operating Procedure (SOP) to conduct 

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validation of new assays. 
• 
This SOP is then customized to each specific test the lab intends to offer. The medical 
director must approve all SOPs, and subsequent changes to SOPs, in the CLIA lab. 
• 
After completing validation experimentation, all results are compiled in a validation 
report and then reviewed and approved by the medical director. 
 
All CLIA labs are under the jurisdiction of their respective state, CLIA licensing boards, and 
undergo an inspection every two years. At the time of inspection, the lab must provide validation 
reports for all assays available on their testing menu for review.  
  
What was the outcome for the validation of Melody®? 
Designing the validation of Melody® was unique; because there are no lab-developed tests using 
protein biomarkers in tears, to our knowledge. The nature of the sample alone provided a new 
level of challenge that made the validation process more stringent. A summary of parameters 
analyzed and the results for the validation can be found in Table 1 and Table 2. 
 
All performance criteria were successfully achieved. Clinical validation resulted in a sensitivity of 
92% and a specificity of 54%. These values were in line with previously observed sensitivity and 
specificity values from development work (work unpublished). 
 
Table 1: Summary of Analytical Validation 
Study 
Parameter 
Sample Description (Name, 
Number, Replicates) 
Results 
Comparison to 
Acceptance Criteria 
(Pass/Fail) 
Accuracy 
20 spiked LGF samples 
Percent recovery between 80-
120% for all samples 
Pass 
Intra-Assay 
Precision 
24 replicates of 3 concentrations 
per analyte 
All %CV less than or equal to 15% 
Pass 
Inter-Assay 
Precision 
Duplicates of 3 concentrations 
1xday for five days. 
All %CV less than or equal to 15% 
Pass 
Sensitivity 
20 replicates of blank per protein 
S100A8 11% 21.10 pg/ml     
S100A9 14% CV 24.32 pg/ml 
Pass 
Linearity 
7 unknown concentrations 
Percent difference less than 15% 
for all samples 
Pass 
 
 
 
 
 
 

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Table 2: Summary of Clinical Validation 
Study 
Parameter 
Sample Description (Name, 
Number, Replicates) 
Results 
Comparison to 
Acceptance Criteria 
(Pass/Fail) 
Accuracy 
26 samples 3 replicates each 
sample 
92% 
Pass 
Sensitivity 
52 LGF samples in duplicate 
92% 
Pass 
Specificity 
50 LGF samples in duplicate 
54% 
Pass 
Stability of LGF 
samples 
One pooled disease LGS 
One pooled non-disease LGS 
N/A 
Refer to Deviations and 
Section B, Number 4 
 
What exactly is Melody®? 
Part 1: Tear sample collection 
Tear samples are collected using a small strip of filter paper, called a Schirmer strip, a Class I 
Medical Device typically used to test for dry eye. The strips have been repurposed for our need to 
collect tear (lacrimal) fluid and the subsequent proteins from the ocular cavity following protocols 
outlined in the literature (3, 4).  
 
 Tear collection is conducted through the following steps (Figure 1):  
1. The strip is placed in the participants' lower eyelid, and having a foreign object in the 
eye will cause the eye to water. 
(The tear (lacrimal) fluid released washes the inner surface of the eyelid and the ocular lens itself, 
allowing proteins to adhere to the strip.) 
2. The strip is left until the liquid reaches the 25 mm mark or 5 minutes has passed.  
3. The strip is then placed in a tube containing a buffered solution and is shipped overnight 
to Namida Lab, Inc. 
 
Figure 1: Collection of tear sample. 
 
 
Part 2: Clinical Lab assay 
During shipment, the proteins leave the strip and go into the buffered solution in the tube. It is 

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this solution that is evaluated using standard ELISA techniques in the high complexity CLIA lab. 
Namida Lab, Inc. is outfitted with a Hamilton Star Plus automated ELISA system. The data 
generated from the ELISA assay is used together with demographic information to generate a 
Melody® score. The score is then compared to the diagnostic threshold, and classification of High 
or Low is reported.  
 
Site clinicians will receive a report containing both the score and the classification for the 
participant. In addition, the site clinicians will be given a Melody® scale (Figure 2) as a reference 
to use when discussing the results with the study participants. (Appendix I) It will be up to the 
individual site clinician's discretion to provide participants with a copy of their test results.  
 
Figure 2: Melody® Scale*
 
*The Melody® scale was generated using 705 samples evaluated during development and 
validation. Percentages in each range show the distribution of normal and breast cancer patients 
that fall within each range. The distribution of scores along the scale will continually be updated 
as new data is collected.  
 
Melody® has been developed and validated as a breast cancer screening test. Melody® is not a 
replacement for screening mammography but is intended to be an adjunct testing option. The 
ideal patient population is women who are at a low-to-average risk for breast cancer (i.e., no 
family history, at or below 12% calculated lifetime risk, have not been labeled high risk by 
previous screening facility). These women may not be motivated to participate in yearly screening 
mammography or have easy access to a screening facility.   
 
Research and development efforts are ongoing to optimize the diagnostic parameters, 
emphasizing methods to reduce the high false-positive rate. Future-focused studies will look at 
additional applications of Melody® for women with dense breasts, clarification of BiRADS 
category 3, and diagnostic applications to elucidate benign vs. breast cancer. These future-
focused directions were developed in collaboration with key opinion leaders in breast cancer 
screening and breast cancer surgical oncology.  
 
2.2 Rationale 
About 1 in 8 US women, close to 13%, will develop invasive breast cancer throughout their 
lifetime. The most significant risk factors for breast cancer are sex, being a woman, and age, 
growing older. Evidence shows that national mammography screening programs have sufficiently 
reduced breast cancer-related mortality. Therefore, the utility of mammography used as a 
screening tool is not the subject in question.  
 
However, both false-positive and false-negative breast cancer diagnosis, excessive biopsies, and 
irradiation linked to mammography application, as well as sub-optimal mammography-based 
screening, such as in the case of high-dense breast tissue in young females, altogether increase 

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awareness among the experts regarding the limitations of mammography-based screening (5).  
 
Disparities in screening mammography are decreasing among medically underserved populations 
but persist among racial/ethnic minorities and low-income women. Additionally, uninsured 
women and those with no usual care have the lowest rates of reported mammogram use. Despite 
apparent increases in mammogram utilization, there is growing evidence that limitations in the 
national survey databases lead to overestimations of mammography-based screening, 
particularly among low-income racial and ethnic minorities (6). 
 
A significant consideration of the Clinical Utility Study, VIOLA, is addressing the barriers such as 
cost, language and acculturation limitation, deficits in knowledge and cultural beliefs, literacy, 
and health system barriers such as insurance and having a source of regular medical care (7,8). 
Severe concerns regarding mammography as the "golden standard" approach, the demand for a 
complementary innovative strategy, and screening tool to cover the evident deficits are under 
review in the VIOLA Study. 
 
2.3 Potential Risks and Benefits 
2.3.1 Known Potential Risks 
Possible risks from participation in study, questionnaires, and medical consultations might include 
minimal psychological discomfort. 
• 
The survey questions will ask about personal experiences, family medical history, possible 
reproductive experiences such as pregnancy, menstrual cycles, and the body. 
• 
The survey questions ask about personal breast health experiences, which may cause 
discomfort for some participants. 
 
Possible risks from the collection of tears are rare but include conjunctivitis or scleral/corneal 
abrasion.  
• 
Conjunctivitis is inflammation of the delicate membrane covering the internal part of the 
eyelid and is attached to the cornea. 
• 
Scleral/corneal abrasion is irritation of the sclera, which is the white of the eye, or of the 
corneal, which is the membrane that covers the pupil and iris of the eye. 
 
Possible risks from the test results include the potential for false-positive and false-negative 
results.  
• 
False positives do occur. A false-positive result occurs when you receive a Melody® 
classification of High even though a screening mammogram finds no area of concern. The 
false-positive rate of Melody® is 46%. 
• 
False negatives do occur. A false-negative result occurs when you receive a Melody® 
classification of Low even though a screening mammogram indicates an area of concern. 
The false-negative rate of Melody® is 8%. 
 
2.3.2 Other Risks 
There could be other unforeseeable risks. 
 
2.3.3 Known Potential Benefits 
The known potential benefits to participation in the VIOLA Study are indirect to the participant. 

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The benefit(s) may be incidental to participation: 
• 
The study will likely yield generalizable knowledge about the participant's disorder or 
condition. 
• 
The study will likely yield generalizable knowledge to understand the disorder or 
condition under study further. 
• 
The study will likely yield participants contributing to knowledge, sharing experiences to 
benefit others, and potentially affecting a condition, culture, perspective, and feeling 
useful. 
3. Objectives and Purpose 
3.1 Primary Objective 
Most women recognize screening mammography as the current gold standard in breast cancer 
screening. However, disparities are present, leaving groups of women without adequate access to 
screening. Gaps in access to screening exist due to geographic location, socio-economic status, 
race, and ethnicity (9).  
 
3.2 Secondary Objective 
Currently, Melody® is not intended to replace screening mammograms but an additional tool to 
facilitate more discussions between providers and patients. Tear sample collection can be done 
during any routine office visit and does not require specially trained personnel. The accessible 
collection allows patients to be tested in a clinic environment they are already familiar with by 
personnel they already know and trust. The goal for early iterations of Melody® is one more piece 
of clinical information gathered, leading to additional conversations about breast health, which 
may be the key to increased participation in annual or bi-annual screening mammograms.  
 
3.3 Exploratory Objective 
The clinical utility of a test is related to the value-added it has for patient management. A test has 
utility if its results (positive or negative) provide valuable information to the patient and the 
provider in making decisions about effective clinical care. It can take the form of improved 
efficiency in clinical decision making, streamlined clinical workflow, better patient outcomes, 
and/or cost offsets or avoidance. 
 
The level of clinical utility evidence required will likely depend upon a variety of factors, including 
the current Standard of Care (SOC), the setting of care, and potential cost offsets to mitigate the 
added cost of care, as well as the magnitude of the cost of the test itself. 
 
The VIOLA Study is primarily concerned with the use of Melody®, its impact on mammography 
screening rates, and the overall participation in the breast health continuum of care. Proving 
Melody's® clinical utility through effective clinical outcomes, economically efficient 
implementation, and adoptability in a workflow is crucial for incorporating the Standard of Care.   
4. Study Design and Endpoints 
4.1 Description of the Study Design 
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exposure(s) and outcome(s) (10). Depending on the direction of inquiry, these studies can be 
directed forward, known as cohort studies, or backward known as case-control studies.  
 
The VIOLA Study is an analytical study designed to quantify a relationship or association between 
two variables – an exposure and an outcome. The exposure, Melody®, is pre-determined for all 
participants to receive as opposed to experimental studies where an investigator assigns each 
participant to receive or not receive a particular exposure. 
 
The VIOLA Study was designed to be directed forward using a cohort population at multiple study 
sites. A cohort is defined as a "group of people with a shared characteristic." In cohort studies, 
different groups of people with varying levels of exposure are followed over time to evaluate the 
occurrence of an outcome. Melody® does not have varying levels of exposure but is an overall 
new exposure for the population. 
 
This observational study will not dictate the cancer screening regimens that the site clinicians and 
participants utilize. Instead, this study collects data on individuals' cancer screening practices, 
cancer outcomes, and other factors if needed. Because no regimens are dictated, the VIOLA Study 
can capture information about and evaluate various cancer screening practices, including the use 
of different tests or cancer screening regimens. 
 
The association of exposure to outcome this study is attempting to define: How does the use of 
Melody® before mammography affect participation rates in breast cancer screening?   
 
4.2 Study Endpoints 
4.2.1 Primary Endpoint 
It is common knowledge that disparities exist in breast health, preventative care, and screening 
mammography. Namida Lab, Inc. knows the potential of Melody® to be a tool that bridges the 
gap between underserved populations and positive health outcomes. The administration of 
Melody® does not require additional appointments or trips and can be done by any member of a 
medical team. 
 
As such, Namida Lab, Inc. is partnering with federally qualified health centers and large employers 
to evaluate the clinical utility of Melody®. Do women in populations with historically low 
compliance rates with screening mammography, who receive Melody® as the first step in the 
breast health continuum of care, participate in screening mammograms at higher rates than 
previous years? 
 
4.2.2 Secondary Endpoint 
Melody® will be offered by prescription only through a recognized medical study site. Results will 
be delivered to the site clinician and communicated to the participant through standard study site 
workflows. Namida Lab, Inc. is interested in evaluating if this additional clinician/participant 
consultation around Melody® test results will foster more participant confidence in the current 
continuum of care. Thus, increasing compliance with recommended breast cancer prevention and 
health screening guidelines. 
 

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4.2.3 Exploratory Endpoint 
A widely accepted definition of clinical utility for an assay is that the assay results lead to a clinical 
decision with a high level of evidence to improve patient outcomes (11). Step one, Melody®, 
provides accurate diagnostic screening information. Step two, Melody's® results, when used in 
managing patients, given the benefits and harms, improves health outcomes in a clinically 
perceivable way compared with alternative management strategies. Melody® is proven useful if 
its results are actionable, driving a treatment decision that leads to a better outcome. 
 
In a broad sense, the utility may be as simple as showing that Melody® provides equivalent or 
increased sensitivity and specificity, leading to equivalent or improved management decisions. 
Melody® is less invasive or incurs less patient harm. Melody® is less costly, providing, at 
minimum, the same benefit with fewer resources. Melody® is more widely or readily available 
than current screening options. Thus, more likely to be used to make patient management 
decisions across a more significant number of women. Does the clinical utility of Melody® 
increase participation in the breast health continuum of care? 
5. Study Enrollment and Withdrawal 
5.1 Participant Inclusion Criteria 
To be eligible to participate in this study, an individual must meet all the following criteria: 
• 
Female 
• 
40 to 74 years old 
• 
Able to undergo the informed consent process 
• 
Willingness to comply with all study procedures 
• 
Available for the duration of the study 
• 
In good general health and at average risk for developing breast cancer 
 
5.2 Participant Exclusion Criteria 
An individual who meets any of the following criteria will be excluded from participation in this 
study: 
• 
Male* 
• 
Currently diagnosed or are receiving treatment for breast cancer 
• 
Have an uninvestigated area of suspicion or concern in their breast 
 
*Note: While Namida Lab, Inc. understands that breast cancer also affects men, there are not 
enough samples in the repository from men with breast cancer to ensure the accuracy of the 
results of Melody® for men. 
 
5.3 Strategies for Recruitment and Retention 
Target sample size: 
• 
An a priori power analysis was conducted using G*Power v3.1.9.2 to determine the 
minimum sample size required to find significance with a desired level of power set at 
0.80 and alpha (a) level at 0.05. Based on this analysis, it was determined that a minimum 
of 205 participants were required to ensure adequate power for a Pearson's Chi-square 
Test of Independence. (12, 13, 14) 
 

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The anticipated site participants' accrual rate will vary; all sites and participants will be located 
within the United States. Participants will be recruited from outpatient clinics, larger employers, 
and/or the general public. Participant recruitment venues are site-specific, for example, 
outpatient clinic monthly clinical breast exam events. Potential participants will be identified and 
approached using inclusion/exclusion criteria and site-specific events and/or communication 
channels. 
 
While exact recruitment methods will be specific to each site, the material will be made available 
in versions suitable for flyers, email, post through social media, or distributed by mail. Forward-
facing participant recruitment materials have been submitted separately with indications on how 
it can be personalization to each site.   
 
The VIOLA Study participants are all women due to the development and validation of Melody®. 
The objectives and endpoints encourage minorities, employee volunteers, economically 
disadvantaged, and/or a medically underserved population to participate in the VIOLA Study. The 
justification for involving vulnerable populations is because they are primarily affected by 
disparities in the healthcare system. Employee volunteers are included because study sites 
provide current medical care and have a trusted relationship with the employee volunteer as a 
current patient. 
 
Careful considerations have been included in the study design and recruitment process to ensure 
minimal harm/risks and maximum participant protection. Participants will have access to 
translated study materials and access to additional healthcare navigation if needed. Employers 
will not be notified of study participation or Melody® results; participation or nonparticipation is 
confidential. Each participant will receive a $25 Walmart gift card when completing the VIOLA 
Study, and there is no cost to participate.   
 
5.4 Participant Withdrawal or Termination 
5.4.1 Reasons for Withdrawal or Termination 
Participants are free to withdraw from the study at any time upon request. The sponsor-
investigator or site-investigator may terminate a participant in the study if: 
• 
Any clinical adverse event (AE), laboratory abnormality, or other medical condition or 
situation that occurs as continued participation in the study would not be in the 
participant's best interest. 
• 
The participant meets an exclusion criterion (either newly developed or not previously 
recognized) that precludes further study participation. 
• 
The participant fails to follow directions for participating in the study. 
• 
The study is canceled and/or for administrative reasons. 
 
5.4.2 Handling of Participant Withdrawal or Termination 
Participants may request to withdraw from the study at any time. Participants that choose to 
withdraw early from the study will be voluntarily surveyed for reasons for withdrawal. The site 
investigator should advise the participant if any safety procedures are recommended and 
determine if the participant is willing to complete those along with any other end of study 
activities. 
 
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withdrawal for study purposes. If they decline, all data past the note of withdrawal will be 
deleted from the record system. However, please note that the FDA requires that any 
information collected up to participant withdrawal cannot be removed from the study. 
 
Participants that are employed by a study site are under no obligation to participate in the study. 
Employees may withdraw from the study at any time and for any reason. Neither the decision to 
participate in the study nor any decision to withdraw will affect performance appraisal or 
employment. Any employee may refuse to participate or may withdraw from the study at any 
time without penalty or anyone blaming the employee. 
 
5.4.3 Withdrawal Process in Mobile App 
Participants will have the option to withdraw from the study by tapping a "Withdraw from Study" 
button within the app. This action will disable notifications and will result in a cessation of data 
collection. If a participant calls the study site requesting withdrawal from the study, the study 
personnel will instruct the participant on initiating withdrawal on the app. It will not be possible 
for any party other than the participant to withdraw from the study within the app. 
 
In the few cases where the participant has received a notification and has initiated contact with 
the study personnel and then selects "Withdraw from Study" on the app, they may still receive 
follow-up communication from the study personnel. In order to stop further communication, 
these participants would need to inform the site personnel that they wish to be withdrawn. 
 
5.5 Premature Termination or Suspension of Study 
This study may be suspended or prematurely terminated if there is sufficient reasonable cause. If 
the study is prematurely terminated or suspended, the sponsor-investigator will promptly inform 
the IRB and provide the reason(s) for the termination or suspension. Site investigators can 
request suspension of the Namida Lab, Inc. app to stop the research. The study may resume once 
concerns about safety, protocol compliance, data quality is addressed and satisfy the sponsor, 
IRB, and/or FDA. 
 
Circumstances that may warrant termination or suspension include, but are not limited to: 
• 
Determination of unexpected, significant, or unacceptable risk to participants 
• 
Demonstration of efficacy that would warrant stopping 
• 
Insufficient compliance to protocol requirements 
• 
Data that are not sufficiently complete and/or evaluable 
• 
Determination of futility 
6. Study Agent 
6.1 Study Agent Description 
6.1.1 Acquisition 
The complete Melody® assay collection kit consists of 25 single-use tear collection pouches and 
return shipping materials. The complete Melody® collection kit used at study sites will be 
obtained from Namida Lab, Inc. The collection kit components for tear sample collection and 
return shipping will be acquired directly from their production facilities by Namida Lab, Inc. 
According to participant enrollment rates, kits will be disbursed to the site investigator. 
Disbursement schedules will be arranged between Namida Lab, Inc. and study sites. (Appendix F) 

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6.1.2 Formulation, Appearance, Packaging, and Labeling 
The component products included for single-use tear collection are Schirmer strips, collection 
tubes, and sterile 1x PBS solution. Components for tear sample collection will be in a sealed, 
tamper-proof pouch with only one set of single-use materials. The pouches will not use a 
commercial appearance. A label will be affixed to each complete Melody® collection kit box and 
single-use pouch with large text stating that the products are for the VIOLA Clinical Utility Study 
Only. 
 
The complete Melody® collection kit box will include, if applicable: the name of the product(s), a 
model number(s), a description of the product(s), safety, use, storage information, and 
manufacturer contact information. In addition, if applicable, any standard product manual 
package inserts will be included. The inserts detail safety information, a description of the 
product, directions for use, technical support, product specifications, regulatory statements, a 
component list, and packaging symbol and definition legends. 
 
An affixed label will instruct users to consult an additional study-specific package insert that will 
also be included for use modifications on this insert. (Appendix F) This package insert will contain 
the name and description of this clinical study, new directions for use detailing the study 
indications and study procedure, and contact information for the sponsor-investigator and site 
investigators. 
 
6.1.3 Product Storage and Stability 
No seal will be broken until the site clinician is ready to collect the tear sample from the 
participant. Expiration dates will be verified before any seal is broken. According to the 
instruction manual specifications for temperature, humidity, and pressure, collection kits will be 
housed in a secure, designated location at the study sites. The collection kits will only be 
accessible to trained study personnel at the site until use. 
 
6.1.4 Administration of Study Agent 
All site investigators, clinicians, and personnel will receive hands-on training for the appropriate 
tear collection method and the proper time frame for the return shipment of tear samples. The 
Instructions for Use (IFU) will be available at all study sites and included in the collection kit box. 
(Appendix E) 
 
6.1.5 Results of Study Agent Administration 
In addition to the tear sample collection, sites will receive the participant Melody® result reports. 
The participant Melody® assay results will be returned digitally through a secure and encrypted 
messaging platform. Each site will have a designated inbox and will only have access to its site-
specific participants. (Appendix I) 
   
6.2 Study Agent Accountability Procedures 
According to the disbursement schedule, collection kits and return shipping materials will be 
distributed to the study sites, which will specify ownership, storage, and use. The kit materials 
will be received by site personnel who have been trained in the safe handling and proper interim 
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personnel will maintain the proper receipt and transfer of all study products. 
 
Should study products be unused and not defective or expired, they will be assigned to the next 
applicable study participant should the product not expire before the anticipated next 
enrollment. Defective, damaged, or expired products will be reported to Namida Lab, Inc. and 
disposed of or otherwise processed according to site-specific and manufacturer policies. 
7. Study Procedures and Schedule 
7.1 Study Procedures / Evaluations 
7.1.1 Study Specific Procedures 
All procedures listed are specific to the study and not considered part of standard clinical care. 
Specific questions and content are provided in the protocol appendix. 
• 
Participant's informed consent will be obtained electronically through Namida Lab, Inc. 
mobile app if the participant has access to a device.* 
• 
Study participant background questionnaire (Demographics, Medical History, Medication 
History, Family Medical History) 
• 
Biological specimen collection and laboratory evaluation. (Melody® assay: tear sample 
collection) 
• 
A discussion/medical consultation of the Melody® assay results will be provided to the 
participant. 
• 
Administration of questionnaires regarding the assessment of study agent, Melody®, and 
patient-reported outcomes. 
*The study sites will have devices on-site or permit paper submissions for participants who do not 
have their own devices. 
 
7.1.2 Mobile App Eligibility and Enrollment Procedures 
The potential participant will first download the Namida Lab, Inc. app. The app will automatically 
ensure compatibility with the iPhone iOS version and Android version. If compatible, the 
participant will continue forward in the app. (Appendix R). See 7.1.6 for alternatives to digital. 
 
The participant will advance to a screen for new user enrollment to create a secure user account 
within the Namida Lab, Inc. mobile app. The participant will select the VIOLA Study from the list 
of available studies. The app will require a digital authentication token to determine eligibility for 
the study, which participants will receive from Namida Lab, Inc. during recruitment. 
 
The study anticipates a substantial volume of participants screened and consented in the initial 
days following study opening. There is a potential risk of overwhelming the study infrastructure if 
all participants can instantly enter the study. To maintain operational efficiency, the study 
monitors will use an enrollment metering schema. 
 
Participants eligible for inclusion may be delayed in consent and enrollment (participant 
recruitment and enrollment portion of the study). Enrollment metering will be adaptable based 
on study and clinical bandwidths, with metering instituted by invitation to consent. 
 
7.1.3 Mobile App Consent, Baseline Demographics, and Medical History Collection 
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participation in clinical research and utility studies. The Namida Lab, Inc. app utilizes the 
ResearchKit and ResearchStack open-source frameworks on the iOS and Android platforms.  
 
As in other mobile-mediated research and studies, the informed consent process in the Namida 
Lab, Inc. app is conducted remotely in an entirely self-administered setting with no required 
contact with the study personnel before consent and enrollment. The approach to informed 
consent for the study has been adapted accordingly to ensure the ethical requirement of 
informedness, i.e., that participants are adequately informed about the study before 
participation, is met. See 7.1.6 for alternatives to digital. 
 
Potential candidates and enrolled participants will be able to contact study site personnel and 
have the ability to ask questions and request clarifications at any time before or during the study. 
This site personnel will be available from the study start date until study closure. Participants who 
successfully pass the eligibility criteria will be directed to a page requesting their consent to 
participate. Participants will be asked to read and sign the informed consent and authorization 
document within the app if they agree to volunteer or participate. A copy of the signed informed 
consent and authorization document will be available for review and download to the participant 
via the app. 
 
The participant will be considered 'enrolled' from this point. After consenting to participate, the 
participant will be directed to complete a brief questionnaire to collect self-reported baseline 
demographics and medical history. (Appendix D) 
 
7.1.4 Overall Procedures for Enrolled Participants 
After completing the baseline demographics and medical history questionnaires, the participant 
will schedule a sample collection appointment/walk-in at their study site. The study personnel 
will collect the tear sample and return it to Namida Lab, Inc. Namida Lab, Inc. will perform the 
Melody® assay lab-developed test and return the participant's results to their study site. The site 
clinician will review the Melody® results with the participant.  
 
The participant will receive a notification informing them that the exit questionnaire has been 
published and is available to complete. Upon completing the exit survey, the participant will be 
notified that their participation in the study is complete. They will receive instructions to claim 
the $25 Walmart gift card. 
 
7.1.5 Standard of Care Study Procedures 
The Standard of Care is determined by the site investigator, clinicians, and personnel. It is not 
within the scope of our expertise or study endpoints to define the participant's path of care 
beyond the safe collection of the tear sample and medically supervised consultation of Melody® 
results.    
 
7.1.6 Alternatives to Study Participation without Mobile Application 
If the participant does not have access to a smartphone/tablet and/or affordable cellular data 
plans, they will not be excluded from the study. All sites will have a Namida Lab, Inc. provided 
tablet that participants may access to participate in the study. 
 
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necessary physical copies of the study material. Each site will have physical copies of all study 
material, i.e., informed consent and questionnaires. The study personnel will engage with 
participants in the study using a traditional clinical trial model.    
  
7.2 Laboratory Procedures / Evaluations 
7.2.1 Clinical Laboratory Evaluations 
Melody®, a tear-based screening assay for breast cancer developed and validated by Namida Lab, 
Inc., a high complexity CLIA certified lab.  
 
7.2.2 Specimen Preparation, Handling, and Storage 
The trained clinician and personnel will follow the step-by-step tear sample collection Instructions 
for Use (IFU) at the study site. (Appendix E)  
 
At Namida Lab, Inc., the trained laboratory personnel will follow the step-by-step Standard 
Operating Procedure (SOP) for specimen preparation, handling, and storage. (Appendix G) 
 
7.2.3 Specimen Shipment 
After the tear sample has been collected from the participant, it should be placed in the pre-paid 
FedEx envelope for overnight shipment to Namida Lab, Inc. The sample must be mailed to 
Namida Lab, Inc. at 1905 Mission Blvd, Ste 6 Fayetteville AR 72703 (Attn: Kelsey Kirchner) on the 
same day it was collected. 
 
Namida Lab, Inc. will accept samples Monday through Thursday, excluding holidays. There are no 
special shipping requirements such as cold storage or biospecimen labels. The postage is pre-
paid, and Namida Lab, Inc. provides all shipping materials. 
 
7.3 Study Schedule 
7.3.1 Recruitment / Enrollment 
Participant Recruitment / Enrollment (Study Intervention) 
• 
Obtain informed consent of the potential participant. 
• 
Obtain medical history to determine eligibility based on inclusion/exclusion criteria. 
• 
Schedule visits for participants who are eligible and available for the duration of the 
study. 
• 
Provide participants with site-specific instructions needed to prepare for the first study 
visit. 
 
7.3.2 Baseline Assessments / Study Intervention 
(Enrollment) / Baseline Visit / Study Intervention 
• 
Obtain informed consent of potential participants verified by signature on study 
informed consent form. 
• 
Verify inclusion/exclusion criteria. 
• 
Obtain demographic information, medical history, and medication history. 
• 
Collect tear (lacrimal) fluid sample for Melody® assay. 
• 
Site-specific procedures, instructions provided to participants, observations after tear 
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7.3.3 Follow-Up / Final Study Visit 
Follow-up Visit (Assessment of Study Endpoints / Safety) 
• 
Site-specific procedures and instructions provided to participants to review assay results: 
Melody® Scale, Score, and Classification. 
 
Script-reporting results 
I received your test results back, and your Melody® classification is **** (High or Low), and your 
score is***.  
 
According to the scale provided by Namida Lab, Inc., in the range, you fall into of *** to *** 
***percent of women had breast cancer and ****were normal.  
 
(It is up to you and your practice's discretion to make recommendations for the next steps in screening)  
 
This practice follows the *** guidelines, and for a woman of your age and family history, we 
recommend a screening mammogram.  
 
(If your practice typically schedules screening mammograms on behalf of patients, you may offer to do 
that now.) 
 
A member of the Namida Lab, Inc. clinical team will reach out to you with the next steps for the 
VIOLA Study.  
 
Final Study Visit 
• 
Site-specific procedures and instructions are provided to participants to complete the 
exit questionnaire(s). 
• 
Site-specific final instructions to the participant if additional care is required. 
 
7.3.4 Early Termination Visit 
Site-specific determination to which of the procedures/evaluations required for the final study 
visit should be done at a termination visit if early termination occurs and if the participant is 
willing. 
7.3.5 Unscheduled Visit 
Site-specific as to how unscheduled visit(s) will be handled and documented. 
7.3.6 Schedule of Events Table 
Procedures 
Study Design / Site Enrollment 
Participant Enrollment / 
Screening / Study Intervention 
Baseline assessment / Study 
Intervention 
Follow-up Assessments of Study 
Endpoints / Safety 
Follow-Up Assessment of Study 
Endpoints / Safety 
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Recruit and consent study site 
X 
 
 
 
 
 
Establish site PI and study agreement consent 
X 
 
 
 
 
 
 On-board and train study site personnel 
X 
 
 
 
 
 
Define site opportunity/channel for participant 
recruitment 
X 
 
 
 
 
 
Site-specific study materials from approved IRB 
submission
X 
 
 
 
 
 
Total participants (n=x is site-specific) 
 
X 
 
 
 
 
Participant mobile app Terms of Use 
 
X 
 
 
 
 
Obtain informed consent 
 
X 
 
 
 
 
Screen potential participants by 
inclusion/exclusion criteria 
 
X 
 
 
 
 
Obtain history/demographics through 
Questionnaire 
 
X 
 
 
 
 
Sample Collection (Study Enrollment or Future 
Appointment – site-specific) 
 
X 
X 
 
 
 
Participant sample sent to Namida Lab, Inc. 
 
 
X 
 
 
 
Namida Lab, Inc. runs Melody® Assay* 
 
 
X 
 
 
 
Namida Lab, Inc. returns Melody® assay results to 
study site 
 
 
X 
 
 
 
Site clinician/Namida Lab, Inc. review Melody® 
results (if requested) 
 
 
 
X 
 
 
Site clinician and study participant review 
Melody® results 
 
 
 
X 
 
 
Study participant completes exit Questionnaire 
 
 
 
 
X 
 
Study personnel completes exit Questionnaire 
 
 
 
 
X 
 
Namida Lab, Inc. distributes study participant 
incentive 
 
 
 
 
X 
 
Ongoing study data analysis at Namida Lab, Inc. 
 
X 
X 
X 
X 
 
Namida Lab, Inc. completes all data of study 
endpoints from sites and participants 
 
 
 
 
 
X 
Namida Lab, Inc. closes site/study 
 
 
 
 
 
X 
Access to Future Studies** at Namida Lab, Inc. 
X 
X 
 
 
X 
 
*Melody® Assay is a high complexity lab-developed test that has been developed and validated by Namida Lab, Inc. and will 
only be run by Namida Lab, Inc. 
**Future studies will be offered in a mobile app; participant will need to meet inclusion/exclusion, Re-Consent for a new study 
 
7.4 Concomitant Medications, Treatments, and Procedures 
All concomitant prescription medications taken during study participation will be recorded as 
determined by the site investigator. Prescription medication is a medication prescribed only by a 
properly authorized/licensed clinician for this protocol. If required by site investigators, 
medications to be reported are concomitant prescription medications, over-the-counter 
medications, and non-prescription medications. 
 
Per the exclusion criteria, any woman currently in treatment for breast cancer cannot participate 
in the VIOLA Study. This includes both local therapy and systemic/adjuvant therapy. Local therapy 
includes surgery, with or without radiation therapy to the breast and nearby lymph nodes. 
Systemic therapy uses drug therapies that travel throughout the body to get rid of cancer cells. It 
includes chemotherapy, hormone therapy, and HER2-targeted therapy.  

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8. Assessment of Safety 
8.1 Specification of Safety Parameters 
Safety is not an endpoint of this study but is a top concern of the sponsor and all site 
investigators, clinicians, and personnel. There can be a significant experience between participant 
and clinician when discussing breast cancer screening and screening results. Participant's overall 
and general well-being is the most significant safety concern; it is site-specific and primarily 
monitored by the site investigators and the clinical study personnel. 
 
8.1.1 Definition of Adverse Events (AE.) 
Adverse event means any untoward medical occurrence associated with the use of an 
intervention in humans, whether or not considered intervention-related. 
 
8.1.2 Definition of Serious Adverse Events (SAE) 
A serious adverse event or serious suspected adverse reaction: An AE or suspected adverse 
reaction is considered "serious" if, in the view of either the sponsor or principal investigator, it 
results in any of the following outcomes: death, a life-threatening adverse event, inpatient 
hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or 
substantial disruption of the ability to conduct normal life functions or a congenital 
anomaly/congenital disability.  
 
Based upon appropriate medical judgment, important medical events that may not result in 
death, be life-threatening, or require hospitalization may be considered serious when they may 
jeopardize the participant. This event may require medical or surgical intervention to prevent one 
of the outcomes listed in this definition. 
 
No examples of a serious adverse event are available for the administration and use of the study 
assay, Melody®. 
 
8.1.3 Definition of Unanticipated Problems (UP) 
Unanticipated problems involving risks to participants or others to include, in general, any 
incident, experience, or outcome that meets all the following criteria: 
• 
Unexpected in terms of nature, severity, or frequency is given (a) the study procedures 
that are described in the protocol-related documents, such as the IRB-approved clinical 
utility study protocol and informed consent document; and (b) the characteristics of the 
participant population being studied; and 
• 
Related or possibly related to participation in the clinical utility study ("possibly related" 
means there is a reasonable possibility that the incident, experience, or outcome may 
have been caused by the procedures involved in the study); and 
• 
Suggests that the study places participants or others at a greater risk of harm (including 
physical, psychological, economic, or social harm) than was previously known or 
recognized. 
 
8.2 Classification of an Adverse Event 
8.2.1 Severity of Event 
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to describe severity. 
• 
Mild – Events require minimal or no treatment and do not interfere with the participant's 
daily activities. 
• 
Moderate – Events result in a low level of inconvenience or concern with the therapeutic 
measures. Moderate events may cause some interference with functioning. 
• 
Severe – Events interrupt a participant's usual daily activity and may require systemic 
drug therapy or other treatment. Severe events are usually potentially life-threatening or 
incapacitating. 
 
8.2.2 Relationship to Study Agent 
The site clinician's assessment of an AE's relationship to the study agent (Melody® assay) is part 
of the documentation process. However, it is not a factor in determining what is or is not 
reported in the study. If there is any doubt about whether a clinical observation is an AE, the 
event should be reported. All AEs must have their relationship to the study agent, Melody®, 
assessed. In a clinical trial, the study agent must always be suspect. To help assess, the following 
guidelines are used. 
• 
Related – The AE is known to occur with the study agent. There is a reasonable possibility 
that the study agent caused the AE or a temporal relationship between the study agent 
and event. Reasonable possibility means there is evidence to suggest a causal relationship 
between the study agent and the AE. 
• 
Not Related – There is no reasonable possibility that the administration of the study 
agent caused the event, there is no temporal relationship between the study agent and 
event onset, or an alternate etiology has been established. 
 
8.2.3 Expectedness 
The sponsor-investigator will be responsible for determining whether an AE is expected or 
unexpected. An AE will be considered unexpected if the event's nature, severity, or frequency is 
not consistent with the risk information previously described for the study agent, Melody®. 
 
8.3 Time Period and Frequency for Event Assessment and Follow-Up 
The occurrence of an AE or SAE may come to the attention of study personnel during study visits 
and interviews of a participant presenting for medical care or upon review by a study monitor. 
 
All AEs, including local and systemic reactions not meeting SAEs' criteria, will be captured on the 
appropriate CRF. Information to be collected includes event description, time of onset, clinician's 
assessment of severity, relationship to study product/agent (assessed only by those with the 
training and authority to make a diagnosis), and time of resolution/stabilization of the event. 
 
All AEs occurring while on study must be documented appropriately regardless of relationship. All 
AEs will be followed to an adequate resolution. 
 
Any medical condition present at the time that the participant is screened will be considered 
baseline. Baselines are not reported as an AE. However, suppose the study participant's condition 
deteriorates at any time during the study. In that case, it will be recorded as an AE. UPs will be 
recorded in the data collection system throughout the study. 
 
Changes in the severity of an AE will be documented to allow an assessment of the duration of 

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the event at each level of severity to be performed. AEs characterized as intermittently require 
documentation of onset and duration of each episode. 
 
The site PI will record all reportable events with start dates occurring after informed consent is 
obtained until seven days (for non-serious AEs) or 30 days (for SAEs) after the last day of study 
participation. At each study visit, the site investigator or clinician will inquire about AE/SAEs the 
occurrence of AE/SAEs since the last visit. Events will be followed for outcome information until 
resolution or stabilization. 
 
8.4 Reporting Procedures 
8.4.1 Adverse Event Reporting 
All adverse events will be collected and reported to the IRB and Namida Lab, Inc. regularly and 
within 30 days. 
 
8.4.2 Serious Adverse Event Reporting 
The study site investigator will complete an SAE Form within the following timelines: 
• 
All deaths and immediately life-threatening events, whether related or unrelated, will be 
recorded on the SAE Form and submitted to Namida Lab, Inc. within 24 hours of site 
awareness. See Section 1, Key Roles for contact information. 
• 
Other SAEs, regardless of relationship, will be submitted to Namida Lab, Inc. within 72 
hours of site awareness. 
• 
All SAEs will be followed until satisfactory resolution or until the site investigator deems 
the event to be chronic or the adherence to be stable. Other supporting documentation 
of the event may be requested by Namida Lab, Inc. and should be provided as soon as 
possible. 
• 
Namida Lab, Inc. will be responsible for notifying the IRB/FDA of any unexpected fatal or 
life-threatening suspected adverse reaction as soon as possible but in no case later than 
seven calendar days after Namida Lab, Inc.'s initial receipt of the information. 
 
8.4.3 Unanticipated Problem Reporting 
All possible unanticipated problems will be reported to the IRB within five (5) days of receiving 
notice of the event if the event requires immediate intervention to prevent serious harm to 
participants or others. 
 
All other possible unanticipated problems will be reported to the IRB as soon as possible. 
Reported no later than ten (10) business days from the date of the event or from the date the 
sponsor-investigator is notified of the event. 
 
Incidents or events that meet the OHRP criteria for unanticipated problems require creating and 
completing an unanticipated problem report form. The site investigator's responsibility is to 
report unanticipated problems to the study sponsor, Namida Lab, Inc., for further reporting to the 
IRB. 
 
The unanticipated problem report will include the following information: 
• 
Protocol identifying information: protocol title and number, PI's name, and the IRB 
project number. 

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• 
A detailed description of the event, incident, experience, or outcome. 
• 
An explanation of the basis for determining that the event, incident, experience, or 
outcome represents an unanticipated problem. 
• 
A description of any changes to the protocol or other corrective actions taken or 
proposed in response to the unanticipated problem. 
 
Sponsor-investigator must promptly report (according to the above schedule) the following 
events to the IRB if the events occur within thirty (30) days of participants' active participation: 
• 
Adverse events, which in the opinion of the sponsor-investigator, are both unexpected 
and related. 
• 
An unanticipated event related to the utility study that exposes individuals other than the 
participants (e.g., investigators, research assistants, students, the public, etc.) to potential 
risk. 
• 
Information that indicates a change to the risks or potential benefits of the utility study. 
For example: 
o An interim analysis or safety monitoring report indicates that the frequency or 
magnitude of harms or benefits may differ from initially presented to the IRB. 
o A paper is published from another study that shows that the study's risks or 
potential benefits may be different than initially presented to the IRB. 
o A breach of confidentiality. 
o Incarceration of a participant in a protocol not approved to enroll prisoners. 
o Change to the protocol taken without prior IRB review to eliminate an apparent 
immediate hazard to a participant. 
o Complaint of a participant when the compliant indicates unexpected risks or 
cannot be resolved by the study personnel. 
o Protocol violation (meaning an accidental or unintentional change to the IRB-
approved protocol) that harmed participants or others or that indicates 
participants or others may be at increased risk of harm. 
o An event that requires prompt reporting to Namida Lab, Inc. 
o Namida Lab, Inc. imposed suspension for risk. 
o Any other event that indicates participants or others might be at risk of serious, 
unanticipated harms that are reasonably related to the study. 
 
8.5 Study Halting Rules 
Administration and result consultations of the Melody® assay will be halted when three grade 3 
AEs are determined to be "probably related." The sponsor investigator will notify the IRB 
immediately when the third grade 3 event is reported, and enrollment screens will stop accepting 
new participants. 
 
8.6 Safety Oversight 
Safety oversight will be the responsibility of the sponsor principal investigator. 
9. Clinical Monitoring 
Clinical site monitoring is conducted to ensure that the rights and well-being of human subjects 
are protected. In addition, the reported study data are accurate, complete, and verifiable, and 
that the conduct of the study follows the currently approved protocol/amendment(s), with GCP, 

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and with applicable regulatory requirement(s). The study monitor will perform clinical site 
monitoring. The appointment and responsibilities of the study monitor are defined in section 
13.5. 
10. Statistical Considerations 
10.1 Statistical and Analytical Plans 
An a priori power analysis was conducted using G*Power v3.1.9.2 to determine the minimum 
sample size required to find significance with a desired level of power set at 0.80 and alpha (a) 
level at 0.05. Based on this analysis, it was determined that a minimum of 205 participants were 
required to ensure adequate power for a Pearson's Chi-square Test of Independence. (12, 13, 14) 
(Appendix L) 
 
Each participant will be required to take an enrollment survey that collects information on race, 
ethnicity, and socio-economic status. Participant's addresses will be obtained as part of the 
requisition process for the CLIA lab, from which information on geographic location can be 
obtained. In addition to the factors listed above, the enrollment survey also collects information 
on status and type of health insurance, reproductive health, breast health knowledge, prior 
screening history, and family and personal history of cancer.  
 
The exit survey has been designed to collect information on the participant experience with 
Melody® and comprehension of the information Melody® relayed through their site clinician. In 
addition, information is collected on participant's intention to schedule/participate in future 
screening mammograms and/or change in intention to participate in a previously scheduled 
screening mammogram.  
 
Data will be analyzed using SPSS Statistics software. To determine the presence of significant 
changes, Unpaired T-tests or Mann-Whitney U-test will be used with a significance level set at P 
< 0.05.  
 
Due to the effect of COVID-19 on screening rates, screening mammogram participation rates will 
be compared to rates reported for the state of Arkansas in 2019.  
 
10.2 Statistical Hypothesis 
Primary endpoint: 
 
• 
Ho= Participation rates in yearly screening mammography with the incorporation of 
Melody® (examined by geographic location, socio-economic status, race, and ethnicity) 
will not be greater than participation rates recorded in 2019. 
• 
H1= Participation rates in yearly screening mammography with the incorporation of 
Melody® (examined by geographic location, socio-economic status, race, and ethnicity) 
will be greater than participation rates recorded in 2019. 
 
Secondary endpoint:  
 
• 
Ho= Participation rates in yearly screening mammography, with the incorporation of 
Melody® (examined by clinical sites), will not be greater than participation rates recorded 

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in 2019. 
• 
Ho= Participation rates in yearly screening mammography, with the incorporation of 
Melody® (examined by clinical sites), will not greater than participation rates recorded in 
2019. 
 
10.3 Analysis Datasets 
Primary endpoint datasets will be broken down by classifications outlined in the table below.  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Analysis of secondary endpoint datasets will be analyzed by comparing screening mammography 
participation rates reported by the clinical site from 2019 to screening mammography 
participation rates observed after the study. 
 
10.4 Description of statistical methods 
10.4.1 General Approach 
For all variables of interest, percent change will be evaluated for statistical significance by 
Unpaired T-test or Mann-Whitney U-test as appropriate. Statistical significance will be set at P < 
0.05. 
 
10.4.2 Analysis of primary efficacy endpoints 
Data for primary efficacy endpoints will be presented as follows: 
Analysis of Primary Efficacy Endpoints 
 
 
VIOLA 
2019 
Total 
Ethnicity 
Hispanic 
N (%of total for 
VIOLA) 
N (% of total for 
2019) 
N (% of total) 
 
Non-Hispanic 
N (%of total for 
VIOLA) 
N (% of total for 
2019) 
N (% of total) 
Primary Endpoint Characteristic 
 
Ethnicity 
 
 
Hispanic 
 
Non-Hispanic 
Race 
 
 
American Indian-Alaska Native 
 
Asian 
 
Black or African American 
 
Native Hawaiian or Other Pacific Islander 
 
White 
Socio-economic status 
 
 
$35,000 or less 
 
$35,000-$80,000 
 
$80,000-$130,000 
 
$130,000-$200,000 
 
$200,000 or higher 
Geographic Location 
 
 
Metropolitan 
 
Nonmetropolitan 

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P value 
 
P =? 
 
 
Race 
American Indian-Alaska Native 
N (%of total for 
VIOLA) 
N (% of total for 
2019) 
N (% of total) 
 
Asian 
N (%of total for 
VIOLA) 
N (% of total for 
2019) 
N (% of total) 
 
Black or African American 
N (%of total for 
VIOLA) 
N (% of total for 
2019) 
N (% of total) 
 
Native Hawaiian or other 
Pacific Islander 
N (%of total for 
VIOLA) 
N (% of total for 
2019) 
N (% of total) 
 
White 
N (%of total for 
VIOLA) 
N (% of total for 
2019) 
N (% of total) 
P value 
 
P =? 
 
 
Socio-economic status 
$35,000 or less 
N (%of total for 
VIOLA) 
N (% of total for 
2019) 
N (% of total) 
 
$35,000-$80,000 
N (%of total for 
VIOLA) 
N (% of total for 
2019) 
N (% of total) 
 
$80,000-$130,000 
N (%of total for 
VIOLA) 
N (% of total for 
2019) 
N (% of total) 
 
$130,000-$200,000 
N (%of total for 
VIOLA) 
N (% of total for 
2019) 
N (% of total) 
 
$200,000 or higher 
N (%of total for 
VIOLA) 
N (% of total for 
2019) 
N (% of total) 
P value 
 
P =? 
 
 
Geographic Location 
Metropolitan 
N (%of total for 
VIOLA) 
N (% of total for 
2019) 
N (% of total) 
 
Nonmetropolitan 
N (%of total for 
VIOLA) 
N (% of total for 
2019) 
N (% of total) 
P value 
 
P =? 
 
 
 
10.4.3 Analysis of the Secondary Endpoints 
Analysis of the secondary endpoints will be presented as follows: 
Analysis of Secondary Endpoints 
 
 
VIOLA 
2019 
Total 
Site 1 
Followed through with screening 
mammogram 
N (%of total for 
VIOLA) 
N (% of total for 
2019) 
N (% of total) 
 
Did not follow through with 
screening mammogram 
N (%of total for 
VIOLA) 
N (% of total for 
2019) 
N (% of total) 
P 
value 
 
P =? 
 
 
 
The analysis will be conducted for each site enrolled in the VIOLA Study.  
 
10.4.5 Adherence and retention analysis 
During the participant's journey through the study, there are various points where adherence and 
retention can be assessed. A log will be generated for each site listing each participant who has 
enrolled, their contact information, and where they are in the study process.  
1. Study enrollment - A list can be generated by the site of participants enrolled. In addition, 
participants can be tracked via Namida Lab, Inc.'s LIMS system, as an open order will be 
generated once the participant's enrollment is complete. 
2. Sample collection - Once the participant has completed sample collection at their site, the 
order will be completed, and the sample received by the lab.  
3. Exit survey - A notification method will be arranged by site, which will allow site 
personnel to alert Namida Lab, Inc. when the results have been reported to study 
participants. Once this has occurred, the participant will be sent an exit survey. 
4. After completing the exit survey, the study participant will receive the $25.00 Walmart 

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gift card incentive. This will allow the study sponsor to track adherence and retention.  
11. Source Documents and Access to Source Data/Documents 
A Case Report Form will be completed for each participant enrolled in the clinical study. The 
investigator-sponsor will review, approve, and sign/date each completed CRF; the investigator-
sponsor's signature serves as an attestation of the investigator-sponsor's responsibility for 
ensuring that all clinical and laboratory data are entered into the CRF are complete, accurate, and 
authentic. Any missing or spurious data will be accompanied by a note to file in the participant's 
record, which will clarify its reason and any action taken afterward. 
 
Source Data are the clinical findings and observations, laboratory and test data, and other 
information in Source Documents. Source Documents are the original records (and certified 
copies of original records); including, but not limited to, all consent forms, app screens, app-
based screening forms, regulatory documents, hospital medical records, physician or office 
charts, physician or nursing notes, participant diaries or evaluation checklists, pharmacy 
dispensing records, recorded data from automated instruments, x-rays, etc. When applicable, 
information recorded on the CRF shall match the Source Data recorded on the Source 
Documents. 
12. Quality Assurance and Quality Control 
12.1 Training 
The study site principal investigator, co-investigators, clinicians, and personnel involved in the 
study who have roles in sample collection and/or Melody® test result consultations have 
completed training to ensure safety and human ethics compliance. The study site investigator, 
designated for each site, must be available for participant-requested consultations. 
 
The investigator-sponsor is responsible for site visits and training the appropriate personnel at 
each study site. This principal investigator will review the method of identifying and enrolling the 
appropriate participants in the study. 
 
The sponsor principal investigator will provide the necessary documents and forms to assist each 
study site on participant recruitment, procedural follow-up, and the completion of forms for the 
study. 
 
Each site shall ensure uniform data collection and protocol compliance as required by the study 
protocol and associated documents. 
 
12.2 Quality Control Committee 
The sponsor principal investigator will be responsible for quality control. 
13. Ethics/Protection of Human Subjects (Participants) 
13.1 Ethical Standard 
The study will be conducted according to the current ICH GCP Guidelines and according to local 
applicable laws and regulations. The IRB will review all appropriate study documentation to 
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where IRB approval has been obtained. The protocol, sample ICF, advertisements (if applicable), 
written information is given to participants, safety updates, annual progress reports, and any 
revisions to these documents will be provided to the IRB by the sponsor-investigator as allowable 
by local applicable laws and regulations. 
13.2 Institutional Review Board 
The protocol, informed consent form(s), recruitment materials, and all participant materials 
will be submitted to the IRB for review and approval. Approval of both the protocol and the 
consent form must be obtained before any participant is enrolled. Any amendment to the 
protocol will require review, approval by the IRB before the changes are implemented in the 
study. All changes to the consent form will be IRB approved; a determination will be made 
regarding whether previously consented participants need to be re-consented. 
 
13.3 Informed Consent Process 
13.3.1 Consent and Other Informational Documents Provided to Participants 
Consent forms describing the study agent, study procedures, and risks are given to the 
participant, and written documentation of informed consent is required before starting 
intervention/administering the study agent. The following consent materials are submitted with 
this protocol: Informed consent form, privacy policies, instructions for use, recruitment materials, 
participant surveys, a sample Melody® report, and Namida Lab, Inc. SOP and CLIA certificate. 
(Appendix) 
 
The consent form will include the following: 
• 
Purpose statement 
• 
Participant commitment 
• 
Costs 
• 
Risks 
• 
Benefits 
• 
Disclosure of alternative 
• 
Statement of confidentiality 
• 
Study contact information 
 
13.3.2 Consent Procedures and Documentation 
Informed consent is a process that is initiated before the individual agrees to participate in the 
study and continues throughout the individual's study participation. Extensive discussion of risks 
and possible benefits of participation will be provided to the participant. Consent forms will be 
IRB-approved, and the participant will be asked to read, review, sign, and date the document. 
 
The site investigator, clinician, and/or trained personnel will explain the utility study to the 
participant and answer any questions that may arise. All participants will receive a verbal 
explanation regarding their comprehension of the purposes, procedures, and potential risks of 
the study and their rights as study participants. Participants will have the opportunity to carefully 
review the written consent form and ask questions before signing. 
 
The participant will have the opportunity to discuss the study or think about it before agreeing to 

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participate. The participant will sign the informed consent document before any procedures 
being done specifically for the study. The participant may withdraw consent at any time 
throughout the clinical utility study. 
 
A copy of the informed consent document will be available to the participant for their records. 
The rights and welfare of the participant will be protected by emphasizing to them that the 
quality of their medical care will not be adversely affected if they decline to participate in this 
study. 
 
13.3.3 Informed eConsent and HIPAA Authorization 
The informed consent will be provided within the study app. It will employ ResearchKit and 
ResearchStack electronic consent framework for the signature view to obtaining signed and dated 
informed consent and HIPAA authorization before enrollment. Traditional paper documents will 
be available for participants who chose not to use the mobile application. Signed consent forms 
will be stored on an encrypted server that is 21 CFR Part 11 compliant. The reviewing IRB must 
approve the protocol and informed consent form before the commencement of the study. Any 
subsequent revisions to the informed consent form must also receive IRB approval before use. 
(Appendix O and Q) 
 
13.4 Participant and Data Confidentiality 
Participant confidentiality is strictly held in trust by the participating investigators, their 
personnel, Namida Lab, Inc., and their agents. This confidentiality is extended to cover the testing 
of biological samples and genetic tests in addition to the clinical information relating to 
participants. Therefore, the study protocol, documentation, data, and all other information 
generated will be held in strict confidence. 
 
All records related to a participant's study data will be stored in locked filing cabinets or on 
computers protected with passwords. No information concerning the study of the data will be 
released to any unauthorized third party without the prior written approval of Namida Lab, Inc. 
The participant will not be identified by name in any publication of the VIOLA Study results. 
 
The study monitor, other authorized representatives of Namida Lab, Inc., or representatives of 
the IRB may inspect all documents and records required to be maintained by the investigator, 
including but not limited to survey records, medical records (office, clinic, or hospital) and 
pharmacy records for the participants in this study. The clinical study site will permit access to 
such records. 
 
The collection, transfer, and storage of data will be conducted in compliance with the HIPAA 
Security Rule and structured to minimize the risk of PHI disclosure. All recorded data will be 
entered into a password-protected database. All data entry forms will be accessed and completed 
electronically through a password-protected log-on. 
 
All user interaction with the web/app-based system, from transmitting access passwords to 
entering sensitive participant data, is done via 128-bit encryption using the secure HTTPS 
protocol. Firewalls ensure that only the minimum traffic required for normal operations can 
traverse the network of web and database servers. The database production servers will be 
housed in secure institutional data center facilities and include failover protection designed to 

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minimize the potential for server downtime. Minimal required personnel are allowed direct 
access to production facilities. The study data will remain secure and be maximally protected 
using production-level data center servers. (Appendix M, N, O, P, Q) 
 
13.4.1 Research Use of Stored Human Samples, Specimens, or Data 
Intended Use: Samples and data collected under this protocol may be used to study biomarkers 
for cancer. No genetic testing will be performed. 
 
Storage: Samples and data will be stored using codes assigned by the sponsor investigator. Data 
will be kept in password-protected computers. Only the sponsor investigator will have access to 
the samples and data. 
 
Tracking: Data will be tracked using LIMS software at Namida Lab, Inc. 
 
Disposition after the study: All stored samples will remain at Namida Lab, Inc. Study participants 
who request destruction of samples will be notified of compliance with such requests. All 
supporting details will be maintained for tracking. 
 
13.5 Future Use of Stored Specimens 
Data collected for this study will be analyzed and stored at Namida Lab, Inc. After the study is 
completed, archived data will remain at Namida Lab, Inc. under the supervision of Dr. Anna Daily. 
The study data may be available for use by other researchers, including those outsides of the 
study. Permission to retain data at Namida Lab, Inc. will be included in the informed consent. 
 
These samples could be used for research into identifying different cancers, their complications, 
and other conditions for which individuals are at increased risk and improve screening and/or 
treatment. 
 
During the conduct of the study, an individual participant can choose to withdraw consent to 
have biological specimens stored for future research. However, withdrawal of consent regarding 
bio-sample storage will not be possible after the study is completed. 
 
13.6 Monitoring 
The sponsor principal investigator shall select a Monitor(s) qualified by training and experience to 
monitor the study. A Monitor may be an employee of the principal investigator's organization or 
an organization contracted by the principal investigator. The Monitor shall assure that the 
investigators comply with the signed investigator agreement, the Clinical Investigation 
Plan/Protocol, IDE regulations, and any conditions of approval imposed by the Investigation Site 
IRB/EC or FDA. 
 
Routine monitoring will occur to: 
• 
Verify that participant enrollment is being achieved. 
• 
Verify that the inclusion/exclusion criteria have been met at enrollment. 
• 
Verify that the participant has signed the correct version of the informed consent. 
• 
Review the medical records of all enrolled participants to ensure all adverse events have 
been captured and properly reported. 

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• 
Verify that the data and imaging are accurate, complete, and backed up by source 
documents. 
• 
Verify that all contracts, certifications, and medical licenses for each site are valid 
through the duration of the study. 
14. Data Handling and Record-Keeping 
14.1 Data Collection and Management Responsibilities 
Data collection is the responsibility of the clinical personnel at the site under the supervision of 
the site PI. The investigator is responsible for ensuring the accuracy, completeness, legibility, and 
timeliness of the data reported. 
 
All source documents should be completed in a neat, legible manner to ensure accurate 
interpretation of data. Black ink is required to ensure the clarity of reproduced copies. When 
making changes or corrections, cross out the original entry with a single line and initial and date 
the change. DO NOT ERASE, OVERWRITE, OR USE CORRECTION FLUID OR TAPE ON THE ORIGINAL. 
 
Copies of the electronic CRF (eCRF) will be provided for use as source documents and maintained 
for recording data for each participant enrolled in the study. Data reported in the eCRF derived 
from source documents should be consistent with the source documents. The discrepancies 
should be explained and captured in a progress note and maintained in the participant's official 
electronic study record. 
 
Clinical data (including AEs, concomitant medications, and expected adverse reactions data) and 
clinical laboratory data will be entered into a 21 CFR Part 11-compliant data capture system 
provided by Namida Lab, Inc. The data system includes password protection and internal quality 
checks, such as automatic range checks, to identify inconsistent, incomplete, or inaccurate data. 
Clinical data will be entered directly from the source documents. 
 
14.2 Study Records Retention 
The sponsor investigator will maintain records in accordance with Good Clinical Practice 
guidelines; to include, if applicable: 
• 
FDA correspondence related to the IDE application and Investigational Plan; including 
copies of submitted form FDA 3500 A, supplemental IDE applications, current investigator 
lists, progress reports, a notice of device recall or disposition, and failure to obtain 
informed consent reports. 
• 
IRB correspondence (including approval notifications) related to the clinical protocol, 
including copies of adverse event reports and annual or interim reports. 
• 
Current and past versions of the IRB-approved clinical protocol and corresponding IRB-
approved consent form(s) and, if applicable, participant recruitment advertisements. 
• 
Signed Investigator's Agreements and Certifications of Financial Interests of Clinical 
Investigators. 
• 
Curriculum vitae (sponsor investigator and clinical protocol site investigators). 
• 
Certificates of required training (e.g., human subject protections, Good Clinical Practice, 
etc.) for the sponsor investigator and listed site investigators. 

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• 
Normal value(s)/range(s) for medical/laboratory/technical procedures or tests included in 
the clinical protocol. 
• 
Laboratory certification information. 
• 
Instructions for on-site preparation and handling of the tear sample collection kits and/or 
other study-related materials (i.e., if not addressed in the clinical protocol). 
• 
Signed informed consent forms. 
• 
Completed Case Report Forms; signed and dated by sponsor investigator. 
• 
Source Documents or certified copies of Source Documents. 
• 
Copies of sponsor investigator correspondence to site investigators, including notifications 
of adverse-effect information. 
• 
Participant screening and enrollment logs. 
• 
Retained biological specimen log. 
• 
Interim data analysis report(s); and the 
• 
Final clinical study report. 
Study documents should be retained for a minimum of 2 years after the last approval of a 
marketing application in an ICH region, if applicable. These documents should be retained for a 
longer period, however, if required by local regulations. No records will be destroyed without the 
written consent of Namida Lab, Inc. 
14.3 Protocol Deviations 
A protocol deviation is any noncompliance with the clinical utility study protocol, GCP, or MOP 
requirements. The noncompliance may be either on the participant, the investigator, or the study 
site personnel. As a result of deviations, corrective actions are to be developed by the sponsor 
investigator and study site and implemented promptly. 
 
These practices are consistent with ICH E6: 
• 
4.5 Compliance with Protocol, sections 4.5.1, 4.5.2, and 4.5.3 
• 
5.1 Quality Assurance and Quality Control, section 5.1.1 
• 
5.20 Noncompliance, sections 5.20.1 and 5.20.2. 
 
Sponsor investigator or study site investigator must not make any changes to or deviate from the 
protocol, except to protect the life and physical well-being of a participant in an emergency. A 
site investigator shall notify the sponsor investigator and the reviewing IRB of any deviation from 
the protocol to protect the life or physical well-being of a participant in an emergency and those 
deviations that affect the clinical investigator's scientific integrity. Such notice shall be given as 
soon as possible, but no later than five working days after the emergency occurred, or per 
prevailing local requirements, if sooner than five working days. 
 
All deviations from the protocol, with the reason for the deviation and the date of occurrence, 
must be documented and reported to the sponsor investigator using the appropriate case report 
form. Sites are also required to report deviations to the IRB per local requirements. Deviations 
will be reviewed and evaluated on an ongoing basis. As necessary, appropriate corrective and 
preventive actions (including notification, re-training, or discontinuation) will be put into place by 
the sponsor investigator. 
 

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14.3.1 Deviation Classifications 
For consistency and reporting, deviations will be classified according to the scheme outlined 
below: 
• 
Type A - Deviation to protect the life or physical well-being of a participant in an 
unforeseen emergency. 
• 
Type B - Deviation based on medical judgment. 
• 
Type C - Deviation due to misunderstanding of protocol requirements (training was an 
issue, and re-training may be required) 
• 
Type D - Deviation due to a situation that is beyond control. 
• 
Type E - Deviation due to an oversight, error, or protocol noncompliance. 
 
If a trend or pattern is observed in a particular deviation type, the sponsor investigator will 
conduct a compliance visit. Documentation of such a visit and any subsequent training will be 
documented in the VIOLA Study regulatory binder. 
 
14.4 Publication and Data Sharing Policy 
De-identified data will be shared across multiple publication sites. Any publication is the 
responsibility of the sponsor principal investigator and is not contingent on any outside party. No 
commercial entity has any right to prevent or change the publication of the data. 
15. Study Administration 
15.1 Study Leadership 
Namida Lab, Inc. will govern the conduct of the study. The Namida Lab, Inc. team will be 
composed of the Sponsor PI, study monitors, study site investigators, and collaborators. 
16. Conflict of Interest Policy 
The independence of this study from any actual or perceived influence is critical. Therefore, any 
actual conflict of interest of persons who have a role in the design, conduct, analysis, publication, 
or any aspect of this study will be disclosed and managed. Furthermore, persons who have a 
perceived conflict of interest will be required to have such conflicts managed in a way that is 
appropriate to their participation in the study. The study leadership has established policies and 
procedures for all study group members to disclose all conflicts of interest. It will establish a 
mechanism for the management of all reported dualities of interest. 
17. Literature References 
1. Smart A. A multi-dimensional model of clinical utility. Int J Qual Health Care. 2006 Oct;18(5):377-
82. DOI: 10.1093/intqhc/mzl034. Epub 2006 Sep 2. PMID: 16951425.  
2. Clinical Laboratory Improvement Amendments of 1988 (CLIA) 42 CFR section 493.1253 part 
(b)(1)(ii)(2003). 
3. Grus FH, Joachim SC, Pfeiffer N. Proteomics in ocular fluids. Proteomics Clin Appl. 2007 
Aug;1(8):876-88. DOI: 10.1002/prca.200700105. Epub 2007 Jul 18. PMID: 21136741. 
4. Posa A, Bräuer L, Schicht M, Garreis F, Beileke S, Paulsen F. Schirmer strip vs. capillary tube 
method: non-invasive methods of obtaining proteins from tear fluid. Ann Anat. 2013 
Mar;195(2):137-42. doi: 10.1016/j.aanat.2012.10.001. Epub 2012 Oct 23. PMID: 23357333. 

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5. Zubor, P.; Kubatka, P.; Kajo, K.; Dankova, Z.; Polacek, H.; Bielik, T.; Kudela, E.; Samec, M.; Liskova, 
A.; Vlcakova, D.; Kulkovska, T.; Stastny, I.; Holubekova, V.; Bujnak, J.; Laucekova, Z.; Büsselberg, 
D.; Adamek, M.; Kuhn, W.; Danko, J.; Golubnitschaja, O. Why the Gold Standard Approach by 
Mammography Demands Extension by Multiomics? Application of Liquid Biopsy miRNA Profiles 
to Breast Cancer Disease Management. Int. J. Mol. Sci. 2019, 20, 2878. 
https://doi.org/10.3390/ijms20122878 
6. Peek ME, Han JH. Disparities in screening mammography. Current status, interventions, and 
implications. J Gen Intern Med. 2004 Feb;19(2):184-94. DOI: 10.1111/j.1525-1497.2004.30254.x. 
PMID: 15009798; PMCID: PMC1492136. 
7. Bossuyt PM, Reitsma JB, Linnet K, Moons KG. Beyond diagnostic accuracy: the clinical utility of 
diagnostic tests. Clin Chem. 2012 Dec;58(12):1636-43. DOI: 10.1373/clinchem.2012.182576. 
PMID: 22730450. 
8. Bossuyt PM, McCaffery K. Additional patient outcomes and pathways in evaluations of testing. 
Med Decis Making. 2009 Sep-Oct;29(5): E30-8. DOI: 10.1177/0272989X09347013. Epub 2009 
Sep 2. PMID: 19726782. 
9. McElfish PA, Su LJ, Lee JY, Runnells G, Henry-Tillman R, Kadlubar SA. Mobile Mammography 
Screening as an Opportunity to Increase Access of Rural Women to Breast Cancer Research 
Studies. Breast Cancer (Auckl). 2019 Sep 23;13:1178223419876296. DOI: 
10.1177/1178223419876296. PMID: 31579384; PMCID: PMC6757489. 
10. Ranganathan P, Aggarwal R. Study designs: Part 3 - Analytical observational studies. Perspect 
Clin Res. 2019;10(2):91-94. doi:10.4103/picr.PICR_35_19 
11. Lesko LJ, Zineh I, Huang SM. What is clinical utility, and why should we care? Clin Pharmacol 
Ther. 2010 Dec;88(6):729-33. DOI: 10.1038/clpt.2010.229. PMID: 21081937. 
12. Cohen, J. (1988). Statistical power analysis for the behavioral sciences (2nd ed.) Hillsdale, NJ: 
Lawrence Erlbaum Associates.  
13. Erdfelder, E., Faul, F., & Buchner, A. (1996). G*Power: A general power analysis program. 
Behavior Research Methods, Instruments & Computers, 28, 1-11. Retrieved from 
http://link.springer.com/article/10.3758/BF03203630. 
14. Faul, F., Erdfelder, E., Lang, A.G., & Buchner, A.  (2007). G*Power 3: A flexible statistical power 
analysis program for the social, behavioral, and biomedical sciences. Behavior Research 
Methods, 39 (2), 175-191. Retrieved from http://www.ncbi.nlm.nih.gov/pubmed/17695343.  
15. FDA. (2020, May 29). FDA's MyStudies Application (App) Technical Background. FDA.gov. 
https://www.fda.gov/drugs/science-and-research-drugs/fdas-mystudies-application-app-
technical-background 
 
Appendix 
A. Schematic of VIOLA Study Design 
**view the diagram on the next page in landscape** 

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B. Participant Recruitment Material 
 

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C. Informed Consent Form 
 

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D. Participant Study Enrollment Survey (Background, Demographic, Medical) 
 

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E. Tear Sample Collection: Instructions for Use (IFU) 
 

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F. Melody® Sample Collection Kit Instructions for Use 
 

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G. Namida Lab, Inc. – SOP Specimen Preparation, Handling, and Storage 
 

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H. Namida Lab, Inc. CLIA Certificate of Registration 
 

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I. Melody® Sample Report 
 

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J. Study Participant Exit Survey/Questionnaire 
 

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K. Study Site Provider Exit Survey/Questionnaire 
 

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L. Namida Lab, Inc. Power Analysis (Sample Size) 
 

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M. Namida Lab, Inc. Privacy Policy 
 

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N. Namida Lab, Inc. Policies for PHI Use and Disclosures (HIPAA) 
 

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O. Namida Lab, Inc. Mobile App Privacy Policy 
 

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P. Namida Lab, Inc. Mobile App Cookie Policy 
 

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Q. Namida Lab, Inc. Mobile App End-User License Agreement (Terms of Use) 
 

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R. Namida Lab, Inc. Mobile App Participant Facing Screenshot(s)