Grail will be moving forward with testing its methylation sequencing blood test, which uses DNA sequencing technology and machine learning algorithms for the early detection not only of multiple forms of cancer in a patient’s genome, but also of each cancer’s origin point within the body. It is being developed for use in patients aged 50 and older.
The test requires only a single blood draw and, according to preliminary research, produces a low rate of false positive results. Grail has enrolled approximately 115,000 patients so far in its planned program of three large-scale clinical studies to evaluate the blood test and create an atlas of genomic cancer markers.
Also this week, the FDA granted Grail’s test the Breakthrough Device designation, which acknowledges its potentially life-saving effects and will expedite its path from development and testing to ultimate approval.
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