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Mainz Biomed Completes Successful Pre-Submission Process with the U.S FDA for ColoAlert’s Pivotal Clinical Trial
Multi-Center Study on Track to Commence in Late 2022Initiated Reimbursement Process with The Centers for Medicare and Medicaid Services BERKELEY, Calif. and
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[{"type":"text","content":"Multi-Center Study on Track to Commence in Late 2022Initiated Reimbursement Process with The Centers for Medicare and Medicaid Services BERKELEY, Calif. and MAINZ, Germany, March 31, 2022 (GLOBE NEWSWIRE) -- Mainz Biomed N.V. (NASDAQ:MYNZ) (“Mainz Biomed” or the “Company”), a molecular genetics diagnostic company specializing in the early detection of cancer, announced today that it has received supportive feedback from the U.S. Food & Drug Administration (FDA) on the Company’s pre-submission package profiling the potential pivotal clinical trial design for ColoAlert, its highly efficacious, and easy-to-use detection test for colorectal cancer (CRC). As Mainz prepares to launch ColoAlert’s pivotal clinical trial, the Company is also pleased to announce the formal commencement of its reimbursement process for ColoAlert by scheduling an initial meeting with The Centers for Medicare and Medicaid Services (CMS) in April 2022. The CMS is a federal agency in the U.S. Department of Health and Human Services (HHS) that administers the Medicare program and works in partnership with state governments to administer Medicaid, the Children's Health Insurance Program (CHIP), and health insurance portability standards. “We are encouraged by the FDA’s supportive commentary on our proposed pivotal clinical trial design for ColoAlert and will now work with our clinical team to finalize the study’s protocols and make the necessary preparations to ensure premier trial execution,” commented Guido Baechler, Chief Executive Officer of Mainz Biomed. “In concert with final pivotal clinical trial preparations, we are excited to pursue reimbursement for ColoAlert and are looking forward to commencing formal discussions with the CMS.” An integral part of Mainz’s clinical execution and medical reimbursement strategies is its partnership with Precision for Medicine, a leading global Clinical Research Organization. Precision for Medicine will continue to work with Mainz’s management team to implement the U.S. focused regulatory and market access strategy for ColoAlert by finalizing ColoAlert’s clinical development plan to ensure the trial design is cost-effective, robust, and efficient. The Company is planning to integrate CMS guidelines into ColoAlert’s pivotal trial design, utilizing currently marketed CRC screening tests as benchmarks to provide the test w...