Geneoscopy Submits Premarket Application for Colorectal Screening Device

Gastrointestinal diagnostic test developer Geneoscopy has submitted a premarket approval (PMA) application to the FDA for its ColonoSight, a stool-based at-home noninvasive screening test that detects colorectal cancer (CRC) and advanced adenomas (AA) in average-risk individuals.

The company based its PMA submission on positive results from a trial of asymptomatic individuals ages 45 to 80 who used the test and later had a standard colonoscopy. The trial results showed 94 percent sensitivity for CRC and 45 percent sensitivity for advanced adenomas, a primary marker for present and future colorectal cancer risk.

In the 45 to 49 age group, the test demonstrated 100 percent sensitivity for cancer and 44 percent sensitivity for AAs. These results are the highest sensitivity profile for a noninvasive CRC screening reported to date, the company said.

The at-home assay was given the FDA’s Breakthrough Device designation in January 2021.