Geneoscopy submits FDA premarket approval application for noninvasive CRC test
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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.
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“The completion of our PMA submission is a major milestone – Geneoscopy’s first regulatory approval application,” Andrew Barnell, CEO and co-founder of Geneoscopy, said in the release. “This product and the years of effort from our team that have brought us here exemplify the dedication to our mission to empower patients and providers to transform gastrointestinal health through innovative diagnostics.”
Barnell added, “The impact this test can have on patient health is beyond exciting, as is the validation of our stool RNA platform. We believe this platform will yield additional tests, including increasingly more precise CRC screening and high-value diagnostic testing for other gastrointestinal indications.”
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