MedCity News May 8, 2024
Geneoscopy received approval for its noninvasive colorectal cancer screening test, which the FDA designated as a breakthrough device. This marks only the second time the FDA has issued an approval for a molecular diagnostic test for colorectal cancer — and the first time the agency has done so for a colorectal cancer test that uses RNA.
Diagnostics startup Geneoscopy earned its first-ever FDA approval this week.
The St. Louis-based company received approval for ColoSense, its noninvasive colorectal cancer screening test. The test — which the FDA designated as a breakthrough device — is approved for adults ages 45 and older who are at average risk for developing colorectal cancer.
The approval marks only the second time the FDA has...
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