Mainz Biomed debuts new colorectal cancer screening test

Molecular genetics diagnostic company Mainz (Germany) Biomed has submitted an application for breakthrough device designation from the FDA for a colorectal cancer screening test. 

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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. 

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