Clinical impact
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Breakthrough test performance

Percentage of cancer deaths caused by cancers without recommended screening tests: 71% Percentage of cancer deaths caused by cancers without recommended screening tests: 71%

The Galleri® test detected cancer signals across more than 50 cancer types, most of which do not have current guideline-recommended screenings.1,4

In approximately 200 people tested, only 1 person would be expected to receive a false positive result.

Galleri test performance: 99.5% specificity

The Galleri test’s low risk of false positives minimizes unnecessary diagnostic testing and patient anxiety.

In participants with cancer, when the Galleri test detected cancer, its prediction of the cancer signal origin was correct 89% of the time. 

Predicting the origin of the cancer signal helps healthcare providers select the appropriate follow-up diagnostics tests or procedures to confirm the diagnosis.

The Galleri Test performance: 89% cancer signal origin accuracy

Sensitivity

76.3% sensitivity in cancers that cause two-thirds of cancer deaths in the US 1,6,7

Different cancers shed DNA into the bloodstream at different rates.8 The proportion of tumor-derived cfDNA in the blood tends to increase as cancer progresses. Cancers that shed more DNA at earlier stages tend to be associated with higher mortality.9 The greater the proportion of cfDNA in a sample, the stronger its signal and the more likely it is to be detected by the Galleri test.5

The cancer types specified here account for 63% of all estimated cancer deaths.6,7 The Galleri test detected a cancer signal in approximately 3 out of 4 people with one of the cancers in this high-signal cancer group.1

Clinical studies and research publications

Learn more about the clinical studies building clinical evidence for the Galleri test.

Clinical evidence supporting the development and validation of the Galleri test has been described in peer-reviewed publications. 

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  1. Klein E, et al. Clinical validation of a targeted methylation-based multi-cancer early detection test. Oral presentation at: American Association for Cancer Research; April, 2021; LB013.
  2. Modeled detection extrapolated to 2020 US population ages 50 – 79. Screening includes methods with United States Preventive Services Task Force (USPSTF) A, B, or C rating (breast, colon, cervical, prostate, and lung), and assumes screening is available for all prostate, breast, cervical, and colorectal cancer cases and 33% of lung cancer cases (based on estimated proportion of lung cancers that occur in screen-eligible individuals older than 40 years).
  3. Data on file from Surveillance, Epidemiology, and End Results (SEER) 18 Regs Research Data, Nov 2017 Submission. Includes persons aged 50 – 79. Estimated deaths per year in 2020 from American Cancer Society Cancer Facts and Figures 2020. Available at: www​.can​cer​.org/​c​o​n​t​e​n​t​/​d​a​m​/​c​a​n​c​e​r​-​o​r​g​/​r​e​s​e​a​r​c​h​/​c​a​n​c​e​r​-​f​a​c​t​s​-​a​n​d​-​s​t​a​t​i​s​t​i​c​s​/​a​n​n​u​a​l​-​c​a​n​c​e​r​-​f​a​c​t​s​-​a​n​d​-​f​i​g​u​r​e​s​/​2​0​2​0​/​c​a​n​c​e​r​-​f​a​c​t​s​-​a​n​d​-​f​i​g​u​r​e​s​-​2​0​2​0.pdf
  4. The Galleri test does not detect all cancers and should be used in addition to, and not instead of, routine cancer screening tests recommended by clinical guideline organizations such as the American Cancer Society or the US Preventive Services Task Force (USPSTF).
  5. 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 – 59.
  6. Pre-specified analysis groups included all cancer types, and a subset of 12 high-signal cancers based on results from the first sub-study and mortality data (anus, bladder, colon/​rectum, esophagus, head and neck, liver/bile-duct, lung, lymphoma, ovary, pancreas, plasma cell neoplasm, stomach). Specifically, the subset of pre-specified high-signal cancers were required to have at least 50% sensitivity on at least one of the three prototype assays from the first CCGA sub-study (whole-genome sequencing, whole-genome bisulfite sequencing, targeted sequencing), and included cancers with high mortality according to the Surveillance, Epidemiology, and End Results program.
  7. American Cancer Society. Cancer Facts & Figures 2021. Atlanta: American Cancer Society; 2021.
  8. Oxnard G, et al. Simultaneous multi-cancer detection and tissue of origin (TOO) localization using targeted bisulfite sequencing of plasma cell-free DNA (cfDNA). Ann Oncol. 2019; 30: LBA77
  9. Venn O, et al. 2019 Cold Spring Harbor Laboratory Meeting: The Biology of Genomes; May 7 – 11, 2019; Cold Spring Harbor, NY.