Galleri® is the first-of-its-kind multi-cancer early detection(MCED) test available. Cancers growing in the body
shed DNA into the bloodstream. Galleri is a blood test
that screens for a “fingerprint” of some of the deadliest
cancers before people have symptoms.1

Galleri Test Facts
Screens for many of the deadliest
cancers, such as pancreatic,
esophageal, ovarian and liver.*

Galleri is recommended for use in adults with an elevatedrisk for cancer, such as those aged 50 or older, and should
be used in addition to recommended single-cancer
screening tests. The Galleri test does not detect all cancers
and should be used in addition to routine cancer screening
tests recommended by a healthcare provider.

<1%GRAIL’s sequencing technology was spearheaded by
Dr. Richard Klausner, who directed the National Cancer
Institute from 1995 to 2001. The extensive clinical researchbacking this technology was among the largest explorationof genomic cancer signals in blood ever undertaken.

false positive rate
(99.5% specificity)1,8140+

clinical study sites contributed to thevalidation of Galleri

Current Cancer Screenings
Recommended single-cancer screenings are powerfultools that can help find cancer at an early stage. However,
only five cancer types have recommended screenings—
breast, cervical, colorectal, lung (for smokers considered
at risk) and prostate cancers.2 While today doctors test
individually for these five specific cancers, nearly 70%
of deaths are caused by cancers without recommended
screening.3**

Our robust clinical development program
consists of studies that are planned tocollectively include

Although early detection has been proven to significantly
improve cancer survival rates4 and reduce the cost andcomplexity of treatment5 for cancers with recommended
screenings, most cancers don’t have recommended
screenings and are detected too late.

Cancers without widespreadscreening recommendations
represent:
all cancer
71% ofdiagnoses.
cancer
~70% ofdeaths.
**

The Galleri test does not detect a signal for all cancers
and not all cancers can be detected in the blood. Galleri
should be used in addition to healthcare provider
recommended screening tests. False positive and false
negative results do occur.

Data from the National
Cancer Institutedemonstrated that
diagnosing cancer early
improves overall 5-year
survival rates from

Costs associatedwith treating late-stage
cancers are

20%–90%4***

than treating
early-stage cancers.7

63

380,000+
participants

2–7xhigher*Sensitivity in study participants with - Pancreas cancer: 83.7% overall (61.9% stage I, 60.0% stage II, 85.7% stage III, 95.9% stage IV). Esophagus cancer 85.0% overall (12.5%stage I, 64.7% stage II, 94.7% stage III, 100% stage IV). Ovary cancer: 83.1% overall (50.0% stage I, 80.0% stage II, 87.1% stage III, 94.7% stage IV). Liver/bile duct cancer: 93.5%
overall (100% stage I, 70.0% stage II, 100% stage III, 100% stage IV).
**Assumes screening is available for all prostate, breast, cervical, and colorectal cancer cases and 43% of lung cancer cases (based on estimated proportion of lung cancers that
occur in screen-eligible individuals older than 40 years).
***“Early/Localized” includes invasive localized tumors that have not spread beyond organ of origin, “Late/Metastasized” includes invasive cancers that have metastasizedbeyond the organ of origin to other parts of the body.

For more information, please visit grail.com.

A New Proactive Tool to Screen for Cancer
MCED tests like Galleri are a fundamentally different approach in early cancer detection. Adding Galleri torecommended screenings gives healthcare providers the chance to screen many of the deadliest cancers
that don’t have recommended screenings today.1,2 Cancer identified early, before a person has symptoms,
may be more easily treated and potentially curable.5The Galleri Test:
Can help screen for many of the deadliest cancers that don’t have recommended screening today,
such as pancreatic, esophageal, ovarian and liver.

Looks for a unique “fingerprint” shared by many types of cancer while maintaining a low false
positive rate.1,8Can identify DNA shed by cancer cells while the patient is still asymptomatic with a false positive rate
amongst patients/participants without cancer of just 0.5%, and specificity >99%.1,8 Galleri provides 75%
sensitivity rates in cancers responsible for two-thirds of cancer deaths, and this goes over 80% for someof the most serious cancers.1*

Can indicate the origin of the cancer with 88% accuracy,** giving healthcare providers a guide tonext steps for diagnosis.8

Approximately doubled the number of cancers diagnosed when added to standard of carecancer screenings.8
The Galleri test does not detect a signal for all cancers and not all cancers can be detected in the blood. Galleri should be used in addition to healthcare
provider recommended screening tests. False positive and false negative results do occur.

How the Galleri Test Works
Galleri is available by prescription only. If ordered by a physician, a blood sample is analyzed to determine if acancer signal is present and, if so, predict the origin of the cancer. If a cancer signal is detected, a healthcare
provider will determine next steps for diagnostic evaluation, which may include personal and family healthhistory, physical examination, and guideline directed evaluation(s) including lab work and imaging. The abilityof an MCED test to help identify the origin of the cancer is critical for informing appropriate next steps.
Cancer signal detectedCancer signal
origin prediction

No cancer
signal detectedTumor sheds cfDNAfragments
into bloodstream

Blood plasma
isolated (contains unique
cfDNA fragments with a“fingerprint” of cancer)

Targeted methylation analysis
of cfDNAa (sequencing,mapping, alignment)

Machine-learningclassifier

cfDNA, cell-free DNA.aBisulfite treatment; targeted probes pull out fragments matching regions of interest. Adapted from Liu MC, et al. Ann Oncol. 2020;31(6):745-759. DOI:10.1016/j.annonc.2020.02.011.

*80%+ sensitivity: Anus, Cervix, Colon/Rectum, Esophagus, Head and Neck, Liver/Bile duct, Neuroendocrine, Ovary, Pancreas, Urothelial Tract**Proportion of ﬁrst or second origins correctly predicted among true positive participants.

For more information, please visit grail.com.

GRAIL Clinical Research Program
Our robust clinical development program consists of studies that are planned to collectively include more than
380,000 participants—and what is believed to be the largest linked datasets of genomic and clinical data inthe cancer field. GRAIL’s clinical program includes the foundational Circulating Cell-free Genome Atlas (CCGA)
development and validation study; the interventional PATHFINDER and PATHFINDER 2 studies; the NHS-Galleri
randomized, controlled clinical study; the STRIVE and SUMMIT observational studies; the REFLECTION realworld registry; and the REACH/Galleri-Medicare study. The largest of these, the NHS-Galleri trial, has enrolled
more than 140,000 participants with the primary objective to assess the clinical utility of an MCED test for
population screening in the United Kingdom (UK) when added to standard of care.

9181

CCGA (n=15,254)
Develop and validatea cell-free DNA-based
MCED test6REFLECTION (n~17,000)
Understand the real-world
experience of Galleri inclinical settings

2STRIVE (n=99,481)
Evaluate MCED
test performance inwomen undergoing
mammography screening

7

PATHFINDER 2 (n~35,000)
Evaluate MCED test
performance in eligible
screening population

3

SUMMIT (n=13,035)
Observational study inpeople at high risk oflung cancer

8

SYMPLIFY (n=6,242)
Assess MCED test in
individuals withsigns/symptoms of cancer

4

PATHFINDER (n=6,662)
Evaluate clinicalimplementation andperceptions of MCED test

9

REACH/Galleri-Medicare(n~50,000)
Understand health equity
impact of Galleri in aMedicare population

5NHS-Galleri (n=142,321)
Assess clinical utility ofMCED for population
screening in the UK762>380,000
participants345

n~ indicates approximate enrollment.

Media Contacts
Kristen Davis: kdavis@grailbio.com
Cammy Duong: cduong@grailbio.com

Important Safety Information:
The Galleri test is recommended for use in adults with an elevated risk for cancer, such as those aged 50 or older. The Galleri
test does not detect all cancers and should be used in addition to routine cancer screening tests recommended by a healthcare
provider. Galleri is intended to detect cancer signals and predict where in the body the cancer signal is located. Use of Galleri is notrecommended in individuals who are pregnant, 21 years old or younger, or undergoing active cancer treatment.
Results should be interpreted by a healthcare provider in the context of medical history, clinical signs and symptoms.
A test result of “Cancer Signal Not Detected” does not rule out cancer. A test result of “Cancer Signal Detected” requires confirmatory
diagnostic evaluation by medically established procedures (e.g., imaging) to confirm cancer.
If cancer is not confirmed with further testing, it could mean that cancer is not present or testing was insufficient to detect cancer,
including due to the cancer being located in a different part of the body. False-positive (a cancer signal detected when cancer is notpresent) and false-negative (a cancer signal not detected when cancer is present) test results do occur. Rx only.

Laboratory/Test Information:
GRAIL’s clinical laboratory is certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) and accredited by theCollege of American Pathologists (CAP). The Galleri test was developed, and its performance characteristics were determined byGRAIL. The Galleri test has not been cleared or approved by the Food and Drug Administration. GRAIL’s clinical laboratory is regulated
under CLIA to perform high-complexity testing. The Galleri test is intended for clinical purposes.

For more information, please visit grail.com.

References
1.

Klein EA, Richards D, Cohn A, et al. Clinical Validation of a Targeted Methylation N-Based Multi-Cancer Early Detection Test Using an Independent
Validation Set. Ann Oncol. 2021;32(9):1167-1177. Doi: 10.1016/j.annonc.2021.05.806.

2.

U.S. Preventive Services Task Force (USPSTF). Rockville, MD: U.S. Dept. of Health & Human Services, Agency for Healthcare Research and Quality.
Recommended cancer screening tests, Grade A,B,C. https://www.uspreventiveservicestaskforce.org/uspstf/topic_search_results.

3.

Estimated deaths per year in 2022 from American Cancer Society Cancer Facts and Figures 2022. Available at: http://www.cancer.org/content/
dam/cancerorg/research/cancer-factsand-statistics/annual-cancerfacts-andfigures/2022/cancer-factsand-figures-2022.pdf. Data on fileGA-2021-0065.

4.

Surveillance, Epidemiology, and End Results (SEER) Program (www.seer.cancer.gov) SEER*Stat Database: Incidence - SEER 18 Regs Research
Data, Nov 2018 Sub. Includes Persons Aged 50-79 Diagnosed 2006-2015. Data on file GA-2021-004.

5.

World Health Organization (WHO). Early cancer diagnosis saves lives, cuts treatment costs. Accessed 2024.
https://www.who.int/news/item/03-02-2017-early-cancer-diagnosis-saves-lives-cuts-treatment-costs.

6.

Hackshaw A, Cohen SS, Reichert H, et al. Estimating the Population Health Impact of a Multi-Cancer Early Detection Genomic Blood Test toComplement Existing Screening in the US and UK. Br J Cancer. 2021;125(10):1432-1442. doi: 10.1038/s41416-021-01498-4.

7.

Reddy SR, Broder MS, Chang E, et al. Cost of Cancer Management by Stage at Diagnosis Among Medicare Beneficiaries.
Curr Med Res Opin. 2022;38(8):1285-1294. doi: 10.1080/03007995.2022.2047536.

8.

Schrag D, Beer TM, McDonnell CH, et al. Bloodbased tests for multi-cancer early detection (PATHFINDER): a prospective cohort study. Lancet.
2023;402:1251-1260. doi: 10.1016/S0140-6736(23)01700-2.

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GALLERI IS A REGISTERED TRADEMARK OF GRAIL, LLC. US-GRL-2300020-2