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Medical Devices / Submissions and Approvals

FDA Clears Clinical Genomics-Quest Diagnostics Fecal Test

Nov. 16, 2017

Clinical Genomics and Quest Diagnostics received FDA-clearance for InSure One, an at-home fecal immunochemical test (FIT) aimed at increasing patient testing.

InSure One requires a single sample of toilet bowl water to detect human hemoglobin in the user’s blood with the goal of detecting lower gastrointestinal bleeding, which may be associated with health conditions such as colorectal cancer and anemia.

The American Cancer Society recommends the test on an annual basis.

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