Progress toward FDA approval for colon cancer blood test
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The US Food and Drug Administration (FDA) is making progress toward the approval of a groundbreaking blood test for colon cancer detection, developed by a biotech company in California. In a new study published in the New England Journal of Medicine, the blood test demonstrated an 83% sensitivity and 90% specificity, showing promising accuracy and reliability in identifying cancer markers. If this innovative diagnostic tool gains FDA approval, it will become the first blood screening test for colorectal cancer eligible for Medicare reimbursement.
Source
Chung DC, Gray DM 2nd, Singh H, Issaka RB, Raymond VM, Eagle C, Hu S, Chudova DI, Talasaz A, Greenson JK, Sinicrope FA, Gupta S, Grady WM. A Cell-free DNA Blood-Based Test for Colorectal Cancer Screening. N Engl J Med. 2024 Mar 14;390(11):973-983. doi: 10.1056/NEJMoa2304714. PMID: 38477985.
Additional Reading
https://www.cnn.com/2024/05/23/health/colon-cancer-blood-test/index.html