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DiaCarta OTC Fecal Occult Blood Test Receives FDA Clearance

NEW YORK – DiaCarta announced on Tuesday that its over-the-counter fecal occult blood test has received 510(k) clearance from the US Food and Drug Administration. 

The iColon Fecal Occult Blood Test allows for early detection at home of blood in stool, which can be clinically relevant for gastrointestinal disorders and colorectal cancer, the company said in a statement. 

The new test complements the Pleasanton, California-based firm's ColoScape test for colorectal cancer, it added. The test detects colorectal cancer-associated mutation and methylation biomarkers in circulating blood and can be used to determine which patients are at high risk for colorectal cancer, the company said.