Shares of Mainz Biomed NV (NASDAQ: MYNZ) soared in pre-market trading on Tuesday after the molecular genetics diagnostic company announced that it had received approval from an independent Institutional Review Board (IRB) for the protocol ReconAAsense.
ReconAAsense is MYNZ’s pivotal study in the U.S. to evaluate the clinical performance of its detection test for colorectal cancer (CRC). After this approval, Mainz Biomed will “now initiate the study, which will form the basis of the data package to be submitted for review by the U.S. Food and Drug Administration (FDA) to achieve marketing authorization.”
MYNZ’s ReconAAsense prospective clinical study is likely to include 15,000 subjects from 150 sites across the United States.
Only two analysts have covered the stock in the past three months and both have rated the MYNZ stock a Buy.
