Geneoscopy announced it submitted an FDA premarket approval application for the noninvasive, stool-based, at-home screening test for colorectal cancer and advanced adenomas, according to a company release.
The submission comes after Geneoscopy’s stool-based test demonstrated 94% sensitivity for CRC and 45% sensitivity for advanced adenomas in the CRC-PREVENT trial. In addition, among patients aged 45-49 years, the test showed 100% sensitivity for cancer and 44% sensitivity for advanced adenomas.
“The completion of our PMA submission is a major milestone – Geneoscopy’s