Skip to main content
Premium Trial:

Request an Annual Quote

Quest, Clinical Genomics' FIT Test Cleared by FDA

NEW YORK (360Dx) – Clinical Genomics and Quest Diagnostics today announced the US Food and Drug Administration cleared InSure One, a fecal immunochemical test, or FIT, designed to detect blood in stool.

Clinical Genomics manufactures InSure FIT tests, including InSure One, which Quest provides to physicians and organized provider groups, including through specialized programs with accountable care organizations across the US. The companies expect the test to be commercially available in early 2018.

InSure One, which can be conducted at home, detects human hemoglobin from blood in fecal samples to aid in the detection of lower gastrointestinal bleeding. Unlike other FIT tests, Insure One only requires a sample of water from the toilet bowl. The toilet water is collected after brushing the surface of the stool to release any blood into surrounding water. The test also requires sample collection from one bowel movement by the patient, compared to its predicate test which required two samples.

Medical conditions associated with lower gastrointestinal bleeding include colorectal cancer, iron deficiency, anemia, diverticulitis, ulcerative colitis, polyps, and adenomas.

In individuals of average risk, starting at age 50, annual fecal immunochemical tests are guideline-recommended for screening programs for the early detection of adenomatous polyps, precursors to cancer, and colorectal cancer. FIT, along with colonoscopy, was recently recommended as a Tier 1 preferred tests for colorectal cancer screening programs by the US Multi-Society Task Force. Despite the availability of these tests and other screening options, low patient participation is a major challenge to screening programs, the companies said.

"InSure One is a significant step forward for the InSure product line and FIT testing in general, because it addresses several factors that may inhibit screening," said Kristie Dolan, general manager of Quest's oncology franchise, in a statement. She noted that the test could be a "valuable asset" in the companies "consultative solution for ACOs" aimed at helping ACOs meet quality metrics associated with value-based reimbursement.