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Geneoscopy Submits PMA Application to FDA for Stool-Based Colorectal Cancer Screening Test

NEW YORK – Diagnostics firm Geneoscopy said Tuesday that it has submitted a premarket approval application to the US Food and Drug Administration for its stool-based screening test to detect colorectal cancer and advanced adenomas in average-risk individuals.

The PMA bid is supported by data from a trial called CRC-PREVENT, in which the firm's RNA-based assay demonstrated 94 percent sensitivity for CRC and 45 percent sensitivity for advanced adenomas, a precursor lesion typically removed when identified during a colonoscopy.

In a subset of subjects aged 45 to 49, the test showed 100 percent sensitivity for CRC and 44 percent sensitivity for advanced adenomas at 89 percent specificity.

"Despite CRC being the second leading cause of cancer death in the US, millions of eligible Americans do not get screened — many due to a lack of knowledge of the importance of screening, lack of access to screening, and concerns about the invasive nature of options like colonoscopy," Geneoscopy CSO Erica Barnell said in a statement. "We are committed to closing this gap."

According to the company, the CRC-PREVENT results meet or exceed the sensitivity profiles reported for other noninvasive CRC screening tests in a prospective setting. As such, the company believes it will be successful in seeing its test approved by the FDA. The agency named the assay a breakthrough device in 2021, a designation that can confer a speedier review process.

Moving forward, Geneoscopy CEO Andrew Barnell said the company's stool RNA platform may yield additional tests, including more precise CRC screening assays and "high-value diagnostic testing for other gastrointestinal indications."