Mainz Biomed Shares Rise Premarket After FDA to Review Cancer Test Kit

By Chris Wack

Mainz Biomed N.V. shares were up 13% to $15.33 in premarket trading Wednesday after the company said its pre-submission filed with the U.S. Food & Drug Administration for ColoAlert has been accepted for review.

The company said that by accepting the pre-submission for review, the FDA will provide feedback on its proposed pivotal U.S. clinical trial design for ColoAlert, its detection test for colorectal cancer.

The FDA feedback is expected in the second quarter of 2022, and will offer Mainz the opportunity to gain preliminary insight and guidance on the potential technical parameters and endpoints of the study, which is on track to begin in 2023.

Mainz is currently marketing ColoAlert by partnering with third-party laboratories for test kit processing versus the traditional methodology of operating a single facility.

Write to Chris Wack at [e-mail]

(END) Dow Jones Newswires

02-23-22 0836ET