Mainz Biomed submits application for FDA breakthrough device designation for CRC product

Mainz Biomed (NASDAQ:MYNZ) announced that it has submitted an application to the FDA requesting breakthrough device designation for its non-invasive, next-generation colorectal cancer (CRC) screening test, which includes its novel portfolio of mRNA biomarkers.

Based on positive clinical studies, the company has defined the final configuration of the next-generation test, including novel mRNA biomarkers, to be used in a pivotal registration study, ReconAAsense.

A clinical analysis involving 295 subjects from 21 specialized gastroenterology centers in the U.S demonstrated a sensitivity for CRC of 97% and 88% for advanced adenomas, with a specificity of 93%.

In a statement, Guido Baechler, CEO of Mainz Biomed, said, “Our next-generation test has shown a significant improvement in sensitivity for advanced adenomas and high-grade dysplasia, combined with high sensitivity and specificity for CRC.”