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GALLERI

MULTI-CANCER EARLY DETECTION TEST

Galleri is the first-of-its-kind multi-cancer early detection (MCED) test available. It can detect a signal shared by more than 50 cancer types, and predict the tissue type or organ associated with the signal to help healthcare providers determine next steps.

The Galleri test is recommended for use in adults with an elevated risk for cancer, such as those aged 50 or older, and is used in addition to recommended single-cancer screening tests.

 

GRAIL’s sequencing technology was developed within Illumina and spearheaded by Dr. Richard Klausner, who directed the National Cancer Institute from 1995 to 2001. The extensive clinical research

backing this technology was among the largest exploration of genomic cancer signals in blood ever undertaken.

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HOW DOES IT WORK?

All cells—cancer and healthy ones—shed DNA, which is called cell-free DNA (cfDNA), into the bloodstream. One of the "hallmarks of cancer" is hypo- and hyper-methylation of DNA.

 

After a blood sample is taken at a healthcare provider’s office or at a GRAIL partner laboratory, the Galleri test uses the power of next-generation sequencing and machine-learning algorithms to analyze cfDNA methylation patterns. The test uses these methylation patterns to determine if a cancer signal is present and, if so, predict the tissue type or organ where the cancer signal originated.

 

If a cancer signal is detected, a healthcare provider will determine next steps for diagnostic evaluation, which may include personal and family health history, physical examination, and guideline directed evaluation(s) including lab work and imaging. The ability of an MCED test to help identify the tissue type or organ associated with the cancer signal is critical for informing appropriate next steps.

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