Mainz Biomed has submitted an application to the US Food and Drug Administration (FDA) seeking breakthrough device designation for its colorectal cancer (CRC) screening test.

This non-invasive next-generation test includes a new suite of mRNA biomarkers and could see expedited approval if granted the designation.

The submission is backed by positive outcomes from clinical studies, including ColoFuture and eAArly Detect, and pooled data from the European and US arms presented at the American Society of Clinical Oncology (ASCO) 2024 conference.

These results have led Mainz Biomed to finalise the configuration of its Next Generation Test, which integrates the faecal immunochemical test (FIT) with mRNA biomarkers.

The advanced AI and machine learning algorithm that Mainz Biomed plans to incorporate into its product was also part of the FDA premarket approval study.

The test's efficacy was demonstrated in a clinical setting involving 295 participants from 21 specialised gastroenterology centres in the US.

Mainz Biomed CEO Guido Baechler said: “On the back of our extremely positive clinical results in all our recent studies, finalising the test which will be used in the pivotal ReconAAsense study and approval process has been an elementary milestone for our company.

“Our Next Generation Test has shown a significant improvement in sensitivity for advanced adenomas and high-grade dysplasias, combined with high sensitivity and specificity for CRC.

“Moreover, we believe that our unique decentralised model of working with third-party laboratory partners provides better access to underserved communities and our simple collection process will increase the adherence to testing.”

The Next Generation Test could precisely distinguish between CRC, advanced adenomas, non-advanced adenomas, and samples without pathological findings.

It reported a sensitivity of 97% for CRC and 88% for advanced precancerous lesions, with a specificity of 93%.