The Food and Drug Administration (FDA) has cleared ‘InSure ONE’, an at-home fecal immunochemical test (or FIT).

The InSure ONE – manufactured by Clinical Genomics and distributed by Quest Diagnostics – detects human hemoglobin from blood in fecal samples to aid in the detection of lower gastrointestinal bleeding.

Compared to InSure FIT, InSure ONE requires sample collection from only one bowel movement instead of two. Unlike other FITs, InSure ONE only requires a sample of water from the toilet bowl after the stool surface has been brushed to release any blood into the water. 

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“InSure ONE was specifically designed with the user in mind,” said Mark Boyle, President of Clinical Genomics IVD. “A test that is easier for the patient to use is far more likely to be employed, which in turn may enhance screening rates and earlier detection of medical issues when they are more likely to be successfully treated.”

The U.S. Multi-Society Task Force recently recommended FIT as a  ‘tier 1’ preferred test for colorectal cancer screening, along with colonoscopy. The task force found FIT to be a low cost test that has been shown to be highly effective when repeated annually. The Company stated that they expect the InSure ONE test to be available in early 2018.

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