Galleri Test for the Detection of Cancer

Natasha J. Pyzocha

NATASHA J. PYZOCHA, DO, FAWM, FAAFP, 98point6, Seattle, Washington

Am Fam Physician. 2022;106(4):459-460

Author disclosure: No relevant financial relationships.

The Galleri test is a multicancer early detection blood test used to identify more than 50 cancer types in asymptomatic adults 50 years or older.^1,2 It uses artificial intelligence analysis of cell-free DNA to recognize patterns associated with cancer and identify the likely tissue of origin. The Galleri test is not meant to replace current population-based cancer screening recommendations and is not approved by the U.S. Food and Drug Administration.³

Test	Indication	Population, frequency	Cost*
Galleri multi-cancer early detection test	Detection of more than 50 cancer types†	Asymptomatic adults with an elevated risk for cancer (such as those 50 years or older); performed annually	$949

Liu MC, Oxnard GR, Klein EA, et al.; CCGA Consortium. Sensitive and specific multi-cancer detection and localization using methylation signatures in cell-free DNA. Ann Oncol. 2020;31(6):745-759.

Galleri. Health systems. Accessed March 20, 2022. https://www.galleri.com/health-systems

United States Securities and Exchange Commission. Form S-1 registration statement: Grail, Inc. Accessed March 29, 2022. https://www.sec.gov/Archives/edgar/data/1699031/000162827920000227/grails-1.htm

Klein EA, Richards D, Cohn A, et al. Clinical validation of a targeted methylation-based multi-cancer early detection test using an independent validation set. Ann Oncol. 2021;32(9):1167-1177.

Lin JS, Piper MA, Perdue LA, et al. Screening for colorectal cancer: updated evidence report and systematic review for the US Preventive Services Task Force [published corrections appear in JAMA. 2016; 316(5): 545, and JAMA. 2016; 316(13): 1412]. JAMA. 2016;315(23):2576-2594.

Jonas DE, Reuland DS, Reddy SM, et al. Screening for lung cancer with low-dose computed tomography: an evidence review for the U.S. Preventive Services Task Force. Evidence Synthesis, No. 198. Agency for Healthcare Research and Quality; 2021.

Beer TM, McDonnell CH, Nadauld L, et al. Abstract from the American Society of Clinical Oncologists Annual Meeting, June 2021. Interim results of PATHFINDER, a clinical use study using a methylation-based multi-cancer early detection test. J Clin Oncol. 2021;39(15 suppl):3010.

U.S. National Library of Medicine. The STRIVE study: development of a blood test for early detection of multiple cancer types. Updated July 31, 2020. Accessed March 20, 2022. https://clinicaltrials.gov/ct2/show/NCT03085888

U.S. National Library of Medicine. The SUMMIT study: a cancer screening study (SUMMIT). ClinicalTrials.gov. Updated July 7, 2022. Accessed August 24, 2022. https://clinicaltrials.gov/ct2/show/NCT03934866

National Health Service. Galleri trial. Accessed June 1, 2022. https://www.nhs-galleri.org/

American Cancer Society. Cancer facts and figures 2022. Accessed March 22, 2022. https://www.cancer.org/research/cancer-facts-statistics/all-cancer-facts-figures/cancer-facts-figures-2022.html

Galleri. Pricing and benefit coverage. Accessed August 5, 2022. https://www.galleri.com/the-galleri-test/cost

Chen X, Dong Z, Hubbell E, et al. Prognostic significance of blood-based multi-cancer detection in plasma cell-free DNA. Clin Cancer Res. 2021;27(15):4221-4229.

Mathios D, Johansen JS, Cristiano S, et al. Detection and characterization of lung cancer using cell-free DNA fragmentomes. Nat Commun. 2021;12(1):5060.

Continue Reading

More in AFP

More in PubMed

Subscribe

Issue Access

Continue Reading

More in AFP

More in PubMed