Grail announces study results validating methylation sequencing approach for multicancer testing

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Grail, maker of the Galleri multicancer early detection (MCED) test, on Friday announced findings from a substudy of the Circulating Cell-free Genome Atlas (CCGA; NCT02889978) study evaluating circulating cell-free DNA (cfDNA)-based MCED tests.

The CCGA Discovery substudy, the results of which have been published in Cancer Cell, is to date the most comprehensive evaluation of approaches for cfDNA-based MCED tests. Using a cohort of 2,800 individuals, the substudy evaluated whole-genome sequencing, whole-genome methylation sequencing, and ultra-deep targeted sequencing approaches to blood-based MCED testing.

The findings showed that the methylation-based approach had the most effective combination of highest cancer signal detection sensitivity (at 98%) and the most accurate prediction of signal origin.

The CCGA study is a prospective, multicenter, longitudinal study aimed at mapping the landscape of genomic cancer signals in the blood of people with and without cancer. Using specimens and clinical data from more than 15,000 individuals at 142 sites across the U.S. and Canada, it will follow up annually with participants for up to five years. The Discovery substudy is the second CCGA substudy to have published results.

The results from this substudy formed the basis of the development, refinement, and validation of the targeted methylation platform used in Grail’s Galleri MCED test, Amoolya Singh, senior vice president of data science and chief scientific officer at Grail, said in a statement. “It’s our origin story and the foundation of our work to transform cancer care with a simple blood test. This defining study made it possible to carefully design a population screening test with a high specificity and low false-positive rate for cancer detection. When combined with standard screenings, this test has the potential to improve detection of cancer in asymptomatic individuals.”

The Galleri test uses next-generation sequencing, data science, and machine learning to detect a shared cancer signal for more than 50 types of cancer. Results for Galleri test performance in the Pathfinder study were presented at the European Society for Medical Oncology (ESMO) Congress 2022.

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