Mainz Biomed NV (NASDAQ:MYNZ) has entered into a Technology Rights Agreement with Socpra Sciences Santé Et Humaines to access a portfolio of mRNA biomarkers for future integration into ColoAlert, a detection test for colorectal cancer (CRC).
- Mainz is currently marketing ColoAlert in Europe by partnering with third-party laboratories for test kit processing versus the traditional methodology of operating a single facility.
- The Company is also preparing to initiate ColoAlert's regulatory pathway for approval in the U.S.
- Under the agreement terms, the Company has the unilateral option to license the exclusive global rights to five gene expression biomarkers.
- In a study evaluating these biomarkers published in the online peer-review journal platform MDPI, study results achieved overall sensitivities of 75% for advanced adenomas and 95% for CRC, respectively, for a 96% specificity outcome.
- The Company will now commence a clinical study in Europe to evaluate the effectiveness of these biomarkers to enhance ColoAlert's utility.
- Mainz Biomed is targeting 1H of 2022 to launch the clinical study.
- Furthermore, data generated by the study may potentially be incorporated into the Company's design of ColoAlert's U.S. clinical trial for consideration by the FDA.
- Price Action: MYNZ shares are trading 79.50% higher at $18.65 during the premarket session on the last check Wednesday.