Mainz Biomed Submits for FDA Breakthrough Device Designation for CRC Screening Test

Mainz Biomed N.V. has announced the submission of its Next Generation colorectal cancer (CRC) screening test for FDA Breakthrough Device Designation. This submission follows positive clinical studies and the finalization of the test’s configuration, incorporating novel mRNA biomarkers.

The company’s recent clinical analysis showed a 97% sensitivity for colorectal cancer and 88% for advanced adenomas, with 93% specificity. The Next Generation Test integrates the Fecal Immunochemical Test (FIT) with mRNA biomarkers and an advanced AI algorithm to enhance detection accuracy.

Mainz Biomed's CEO, Guido Baechler, emphasized the importance of this milestone, highlighting the test's significant improvement in sensitivity and specificity. The testing process aims to transform colorectal cancer screening practices and reduce global cancer mortality rates.

The FDA Breakthrough Devices Designation aims to accelerate the development and review of medical devices that provide more effective treatment or diagnosis of life-threatening conditions. Approval will enable better access to early cancer detection methods.