Collection of Blood Products for Use in the Development and Validation of Point-of-Care In Vitro Diagnostic Liver Function Test Devices
Conditions: Liver Diseases, Healthy, Liver Cirrhosis, Liver Fibrosis
Sponsor: Group K Diagnostics Inc.

 
Laura M Ferguson, PhD 
Group K Diagnostics 
page 1 
Protocol:  Collection of Blood Products for Use in the Development and Validation 
of Point-of-Care In Vitro Diagnostic Liver Function Test Devices 
Study GKD001 
NCT # Not Yet Assigned 
IRB Approved Date 6/23/2022 
 
 
 

 
Laura M Ferguson, PhD 
Group K Diagnostics 
page 2 
 
Clinical Study Protocol  
Title of Clinical Study: 
Collection of Blood Products for Use in the Development and Validation of 
Point-of-Care In Vitro Diagnostic Liver Function Test Devices 
Protocol Short Title: 
Blood Collection for Development of Diagnostic Tests 
Protocol Number: 
GKD001 
eIRB Number 
Pro00064273 
Principal Investigator: 
Laura M Ferguson, PhD 
Chief Scientific Officer, Group K Diagnostics 
Phone: 484-633-7853 
Email: Laura.Ferguson@GroupKDiagnostics.com 
Study Sponsor: 
Group K Diagnostics 
1015 Chestnut St Suite 1010 
Philadelphia, PA  19107 
Study Site 
Group K Diagnostics 
1015 Chestnut St Suite 1200 
Philadelphia, PA  19107 
Number of Subjects 
150 Adults over 6 months 
Study Start Date: 
June 27, 2022 
 
 
TABLE OF CONTENTS 
1. Study Overview 
2. Study Objective 
3. Study Background 
4. Study Design 
5. Characteristics of Study Population 
6. Subject Recruitment 
7. Study Procedures  
8. Subject Confidentiality  
9. Data Disclosure  
10. Risk / Benefit  
11. Data and Safety Monitoring 
ATTACHMENTS 
A. Study Enrollment Form 
B. Informed Consent and Authorization Form 
C. Recruiting Flyer 
D. Recruiting Social Media Post  
 
 

 
Laura M Ferguson, PhD 
Group K Diagnostics 
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1. Study Overview 
The present clinical study is designed to collect blood samples to support the development and validation a new 
diagnostic device platform for quantitative point-of-care and at-home testing of blood for various analytes instructive 
of patient health. The blood analytes of initial interest are instructive of liver health. The target population for this 
study includes adults who are healthy or who may have liver disease or be on medications that may impact liver 
function. Initial reach activities will rely on standard venous blood draws and later activities will include finger stick 
capture of capillary blood, as well.  
2. Study Objectives  
2.1 To collect blood samples for use as both fresh and frozen specimens in the development and validation of 
quantitative tests for bilirubin, ALT (alanine transaminase), and AST (aspartate aminotransferase) using a 
novel investigational in vitro diagnostic (IVD) device. 
2.2 To perform structured testing protocols using investigational test devices to support statistical analysis of the 
device analyte test results to confirm reproducibility, linearity, repeatability, and other assessments to 
demonstrate the devices will be safe and effective when used as intended. 
2.3 To prepare investigational study reports for evaluation of the IVD tests for 510(k) clearance by the FDA.  
3. Study Background  
Outpatient diagnostics are time-consuming and expensive due to the long test turnaround times, difficult result release 
workflows, and the need for specially trained staff involvement. Turnaround time for diagnostics tests can be up to 5 
days or more, as patients may have to travel to a separate facility to have labs drawn, and those lab draws follow a 
complex workflow. Since testing is offsite, a significant number of patients never make it to their appointments and 
are therefore not retained in the system. Time delay or non-compliance can make acute problems even more serious. 
Additionally, lab samples may have to be sent to a third location to have actual clinical testing performed on them. 
This causes patients to be lost to follow up when doctors attempt to provide patients with results but are unable to get 
in touch. Beyond time and workflow difficulties, tests can cost anywhere from $15-$100 per test depending on a 
myriad of factors such as insurance, plan coverage, and provider. Given that over two-thirds of all clinical decisions 
are based on laboratory testing (COLA, 2015) and in a 2002 survey of the US, 77% of providers were unable to 
contact their patients with abnormal diagnostic results (White, 2002), diagnostics are not working efficiently for 
outpatient providers. These studies show that lack of access to fast point of care results leads to significant problems 
in continuum of care and effective care. Very few rapid diagnostics are used by doctors, as modular machines are 
often cost or workflow prohibitive. Many rapid diagnostics require a trained technician and have high-cost hardware 
and certifications. The rapid diagnostics that are often used are tests such as pregnancy tests or rapid strep tests that 
are in multiple different platforms and are rate-limited in how many tests a practice can adopt.  
Group K Diagnostics (GKD) intends to transform healthcare through innovative, rapid diagnostics. Inefficiencies of 
current lab solutions will be solved by bringing the "lab" to the provider and allowing practitioners to run diagnostic 
tests onsite in doctors’ offices and clinics. With a low-cost reliable system, providers have actionable information 
before the patient leaves the office. GKD is developing a paper microfluidic platform (KromaHealth Kit) with an 
accompanying mobile application (KromaViewer). The KromaHealth Kit is a simple, cost-effective device with one 
or more test windows. These windows have a mix of dried proprietary reagents that when combined with a patient’s 
drop of blood or serum will produce a colorimetric change. The KromaHealth Viewer on a mobile phone in concert 
with a low-tech viewing light box is then used to interpret the color change and transmit results to a doctor or to the 
patient.  
Group K currently has a 510(k) submission under review with the FDA for a bilirubin only test device that will be 
used in clinical laboratories. The present study will support obtaining newly requested performance data on the IVD 
device under review and the development and validation of a 3-analyte test IVD device on the same platform. 
 
 

 
Laura M Ferguson, PhD 
Group K Diagnostics 
page 4 
4. Study Design  
4.1 Enrolled subjects will provide one standard venous blood draw performed by a certified phlebotomist. The 
blood will be captured in a barcoded venipuncture tube with a copy of the barcode affixed to the enrollment 
form. Some enrolled subjects will also have a finger stick of blood captured in a measured capillary tube. 
Subjects will be allowed to participate in the study up to 1 time per week or may choose to only participate 
once. 
4.2 Development and validation protocols will be performed using aliquots of the fresh blood samples and 
remaining serum will be aliquoted and stored for further validation work.  Some studies will require fresh 
samples while others can be performed using frozen.  
4.3 Statistical analysis of the development protocols will dictate the number of samples required for validation 
studies. At this time, it is projected that less than 300 individual fresh blood samples will be required to 
complete the entirety of the work for submission of the validation reports to the FDA. 
4.4 The study duration is approximately six months with completion expected by December 31, 2022. 
4.5 All study staff will be well trained on the study protocol and have current certifications for the roles they will 
perform in this study. 
4.6 Study subjects will be consented, enrolled, and have blood drawn in a private area of the office with only the 
phlebotomist, staff member obtaining informed consent, and possibly the study PI present. Patients will be 
given ample time to have all their questions answered. 
5. Characteristics of the Study Population  
5.1 Target population:  adults, 18 years of age and older, with varying liver health.  
5.2 Key inclusion criteria: 
5.2.1 
18 years of age and older 
5.2.2 
Able to read and understand an informed consent form written in English 
5.3 Key exclusion criteria: 
5.3.1 
Pregnancy 
5.3.2 
Participated in the present study within the last 6 days 
5.3.3 
Subject is subjectively unwell at the time of enrollment visit 
5.3.4 
Subject previously participated and has asked to be withdrawn from the study  
 
6. Subject recruitment  
The study recruitment will involve posting of the study’s call for volunteers on physical displays in public areas near 
the study site, on social media platforms, via email list serves, and on the sponsor’s website. Sponsor employees will 
also send links to the study recruitment pages on social media and the sponsor’s website to their friends and family. 
The physical and electronic recruitment posts will include a phone number to contact to gain more information. 
Potential subjects will be informed of the criteria for study inclusion, data to be collected during study enrollment, as 
well as the risks and benefits study enrollment. This information is provided in the consent form and presented 
verbally during the consent process. 
7. Study Procedures  
7.1 Subject Enrollment 
7.1.1 
Subjects contact study phone number supplied on recruiting postings and are asked the following 
screening questions: 
a. Are you 18 years of age or older? 
b. Can you read and understand an informed consent form written in English? 

 
Laura M Ferguson, PhD 
Group K Diagnostics 
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c. Are you currently pregnant? 
7.1.2 
Based on the answers to the screening questions, a subject will be invited to enroll in this study and 
a study visit will be scheduled. 
7.1.3 
When the subject arrives for the scheduled visit, they will be asked the screening questions again for 
confirmation. Based on the answers, they will be given the informed consent form to read and discuss 
with study staff. They will be encouraged to ask any questions about the conduct of this study that 
they wish. 
7.1.4 
Informed consent will be obtained by signature, and a copy made for the subject to take. 
7.1.5 
Once enrolled, the following information will be gathered and recorded in the Study Enrollment 
Form: 
a. Full name 
b. Date of birth 
c. Phone number 
d. If they are feeling healthy today 
e. If they have any diagnosed liver conditions or are on any medications that may affect liver 
function, and if so, what these are 
7.1.6 
A phlebotomist will perform a standard venous blood draw to collect roughly 3 mL (milliliters) of 
blood using a 3.5 mL barcode-labeled venipuncture tube. (At a later phase in study research, 
volunteers will also have 30 µL of blood taken by finger stick). 
7.1.7 
Subjects will be monitored for any immediate adverse effects of the blood collection procedure. 
7.1.8 
Subjects will be given the copy of the informed consent form and a $25.00 pre-loaded gift card as 
reimbursement for their time and transportation to the study site.  
7.1.9 
Subjects will be invited to contact the study Principal Investigator should any questions or concerns 
arise after leaving the study site and reminded that they may request to participate again in the study 
if they so choose. 
7.2 Biobanking of Blood Samples 
Venous blood samples will be allowed to clot, and serum will be drawn off. Serum will be aliquoted for use 
in barcode-labeled tubes. Some aliquots will be used fresh, and others stored frozen. The retained samples 
will used to continue development and validation of the in vitro diagnostic tests. 
Finger stick blood samples will be used immediately for testing. 
7.3 Laboratory Testing 
Various structured testing protocols will be performed using investigational test devices to support statistical 
analysis of the device analyte test results to confirm reproducibility, linearity, repeatability, and other 
assessments to demonstrate the devices will be safe and effective when used as intended. Investigational 
device test results will not be provided to study subjects. 
7.4 Data Analysis Plan 
Structured testing protocols and statistical analysis plans have been created based on CSLI standards for 
assessment of critical performance parameters. These parameters include single and multi-site precision and 
repeatability, linearity, Limit of Blank/Limit of Determination, device stability, and interference of 
anticipated compounds. Other parameters may be assessed based on the outcome of the pre-planned analytics. 
Investigational device study reports will be submitted to the FDA in support of making the new test devices 
available to the healthcare community. 
 
 

 
Laura M Ferguson, PhD 
Group K Diagnostics 
page 6 
8. Subject Confidentiality  
Subject enrollment logs will be kept on a secure server with access only by PI and one study staff member designate. 
Enrollment logs will be the only documentation linking the blood sample barcode to the individual subject. Blood 
and corresponding test results will be linked via unique barcode identifiers. The linking set will be maintained in a 
21 CFR Part 11 compliant electronic laboratory management system. The investigator assures that subject’s 
anonymity will be maintained and that their identities are protected from unauthorized parties. The subjects will be 
informed that representatives of the Sponsor of the study, the overseeing IRB, FDA, or EC, or regulatory authorities 
may inspect their study enrollment records to verify the information collected, and that all personal information made 
available for inspection will be handled in strictest confidence and in accordance with local data protection laws. 
Only necessary study staff will have access to data. Though we do not expect any breaches of confidentiality, if they 
do occur, they will be reported directly to the IRB within 24 hours of after discovery.  
All potential participants will have their questions answered and will be consented in a private area of the study site. 
9. Data Disclosure  
Investigational device study reports supplied to the FDA will contain no identity information about the subjects who 
participated in this clinical trial  
10. Risk / Benefit  
10.1 
Potential Study Risks  
Study inclusion involves the minimal risk inherent to standard venipuncture and finger stick procedures. 
Some slight risks of standard venous blood draws are pain from the needle going through skin into the vein, 
mild bruising, clots under the skin, lightheadedness, possible fainting, and rarely, infection. Subjects will 
have clear instructions as to how to reach the team if questions, concerns or adverse events occur after leaving 
the study site. There is a potential risk of loss of privacy and breach of confidentiality which will be 
minimized only using barcode and de-identified demographic information outside of the enrollment process.  
No aspect of the study data analysis plan requires accessing the original enrollment documentation, by either 
hard copy or electronic form.  
10.2 Potential Study Benefits 
There will be no direct benefit to the subjects from participation in this study; the data and conclusions derived 
from this study, however, will support evaluation of technology designed to increase access to clinical 
diagnostic tests. 
10.3 Alternatives to Participation 
Participation is voluntary and optional. Potential subjects may chose not to participate.  
11. Data and Safety Monitoring  
Enrollment data and subject safety will be monitored by the PI and/or study staff during subject visits. Any adverse 
events that occur during subject visits or any study-related adverse events that arise after the subject visit, will be 
reported to the IRB. Investigation device test data will not be shared with subjects.