Mainz Biomed Partners with Trusted Health Advisors to Support U.S. Go-To-Market Strategy for Next Generation Early Colorectal Cancer Diagnostic
In the U.S., Mainz Biomed is in final regulatory planning stages of ReconAAsense clinical trial to seek Premarket Approval (PMA) for its next generation diagnostic test.
- In the U.S., Mainz Biomed is in final regulatory planning stages of ReconAAsense clinical trial to seek Premarket Approval (PMA) for its next generation diagnostic test.
- The Company currently commercializes its first-generation test in Europe and in select international territories through its flagship product ColoAlert® via partnerships with third-party laboratories.
- “Detecting AA lesions allows for early intervention and significantly increases the chance of successful treatment and survival.
- The study’s primary objectives include calculating sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) in average-risk subjects for CRC and AA.