Understanding Positive Predictive Value (PPV)The importance of PPV for interpreting Galleri® Cancer Signal Detected results
A sample of asymptomatic individuals
ages 50-79 years taking the Galleri test

What Is PPV?
PPV represents the number of individuals
who receive a Cancer Signal Detected
test result who had cancer diagnosed.
It can help guide the discussion on theimplications and appropriate next steps.

1000

9

What Does That Mean?
Galleri’s PPV is 43.1% meaning thatabout 4 out of 10 individuals with a“Cancer Signal Detected” result areexpected to have a confirmed cancer
diagnosis following diagnostic work-up.

PPV for the Galleri Test is:991

Cancer Signal Detected

4

CancerDiagnosed(True Positives)

43.1%

PPV is 43.1 %No Cancer Signal Detected

5Cancer
Not Found**Represents cancer
may not be present,incorrect cancer
signal origin (CSO) or
limitations of imaging

15

CancerDiagnosed

through otherscreening or
clinical signs/symptoms

976

CancerNot Found(True Negatives)

NPV is 98.5%

In the PATHFINDER study1, out of 6,578 participants tested with Galleri, 58 had a Cancer Signal Detected result.
Of these, 25 had a cancer diagnosed. 25/58 = 43.1%

PPV of Single Cancer Screening Tests
There has been no head-to-head PPV comparisonof Galleri to these standard-of-care screening tests.

Current standard-ofcare screening tests
for individual cancers
have PPVs in therange of 1-10%.
PPV (%)The Galleri test
should be usedin addition torecommended singlecancer screenings.

1056.9% †6.9% ‡COLORECTAL(FIT)4

LUNG 54.4%<1% †0BREAST(MAMMOGRAPHY)2

CERVICAL 3See Important Safety Information on reverse†Pre-cancerous lesions were excluded. ‡Based on previous USPSTF recommendations of adults 55–80 years with a 30 pack/year smoking history. 1 Schrag D, et al. Presentation at European
Society for Medical Oncology (ESMO) Congress; September 9-13, 2022 2 USPSTF. 2016. Lehman, et al. Radiology. 2017;283(1):49-58. 3 Kim, et al. JAMA. 2018;320(7):706-714. 4 Imperiale T, et al.
N Engl J Med 2014;370:1287-1297. 5 Pinsky, et al. Ann Intern Med. 2015 Apr 7;162(7): 485–491. Data on file. GA-2021-0069.

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 “No Cancer
Signal 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 meanthat cancer is not present or testing was insufficient to detect cancer, including due to the cancer being located in a different partof the body. False-positive (a cancer signal detected when cancer is not present) 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
by GRAIL. 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.

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