Molecular genetics diagnostic company Mainz (Germany) Biomed has submitted an application for breakthrough device designation from the FDA for a colorectal cancer screening test.
If granted, the test’s approval process could be accelerated. The submission comes after two clinical studies conducted on the test showed consistently positive results, according to a July 9 news release from Mainz.
The test combines a traditional fecal immunochemical test with special biomarkers, alongside artificial intelligence and machine-learning algorithms.