Method: The Galleri test is a proprietary next-generation sequencing (NGS)-based screening test developed by GRAIL, LLC (CLIA #34D2231294), analyzing DNA methylation patterns in cell-free DNA from peripheral whole blood. This is a screening test - not a diagnostic test. A positive result requires diagnostic workup by a qualified healthcare provider. For full methodology and intended use, visit galleri.com.
A derived biomarker is a value that is calculated from other directly measured biomarkers rather than being measured directly in the lab.
Key benefits of Proprietary Cancer Signal Detection testing
- Multi-cancer early detection from a single blood draw
- screens for signals across 50+ cancer types including many with no dedicated screening test
- 99.5% specificity and 0.5% false positive rate (per GRAIL PATHFINDER study)
- Cancer Signal Origin prediction to guide clinical follow-up
What is Proprietary Cancer Signal Detection?
The Galleri test analyzes cell-free DNA (cfDNA) shed by cells into the bloodstream. Using targeted methylation sequencing, it examines over 100,000 DNA methylation regions and more than 1 million CpG sites to identify abnormal methylation patterns associated with cancer. The result is binary: cancer signal detected or no cancer signal detected.
Why is Proprietary Cancer Signal Detection important?
The majority of cancers lack routine screening tests. The Galleri test may detect shared cancer signals across 50+ cancer types - including pancreatic, esophageal, ovarian, and liver cancers - at stages where more intervention options may be available. With 99.5% specificity and a false positive rate of 0.5% (per GRAIL PATHFINDER study), a detected signal is highly specific. This is a screening test - not a diagnostic test - and all detected signals require clinical evaluation and follow-up testing.
What insights will I get?
A "No Cancer Signal Detected" result means no cancer-associated DNA methylation pattern was identified in your sample at this time. A "Cancer Signal Detected" result includes a predicted Cancer Signal Origin (CSO) identifying the tissue type where the signal may originate - enabling targeted diagnostic follow-up. This test screens for a signal; it does not diagnose cancer. Clinical evaluation is required for all positive results.
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