Mainz Biomed N.V, a leader in molecular genetics diagnostic solutions for early cancer detection, has announced a strategic collaboration with Trusted Health Advisors (THA), a prominent player in supporting the launch and management of commercial programs for diagnostic products in the United States.

The focus of Mainz Biomed lies in revolutionizing colorectal cancer (CRC) screening diagnostics. They are in the final stages of clinical development for a highly precise and user-friendly nucleic acid-based detection test. This test is intended for distribution through a unique business model involving partnerships with third-party laboratories. Currently, Mainz Biomed is finalizing regulatory plans for the ReconAAsense clinical trial, which aims to seek Premarket Approval (PMA) for its advanced diagnostic test in the United States. While the company already markets its first-generation test, ColoAlert®, in Europe and select international regions, it aims to extend its reach into the American market with ReconAAsense.

Guido Baechler, Chief Executive Officer of Mainz Biomed, expressed excitement for the partnership with THA, citing its potential to expedite the company's U.S. market entry strategy for CRC screening. Dr. Jay Wohlgemuth, Managing Partner at THA, highlighted the transformative potential of Mainz Biomed's technology in detecting Advanced Adenoma lesions, which could significantly enhance early intervention and treatment outcomes for patients. Dr. Ray Tabibiazar, also a Managing Partner at THA, commended Mainz Biomed's innovative approach to commercialization, emphasizing its potential to broaden patient access to crucial diagnostic tests and improve overall health outcomes.

Led by Drs. Wohlgemuth and Tabibiazar, THA brings a wealth of experience and expertise in healthcare innovation and commercialization to the partnership. Dr. Wohlgemuth's background includes extensive experience in senior executive roles at Quest Diagnostics and as a co-founder of CareDx, while Dr. Tabibiazar boasts a successful track record as a CEO, entrepreneur, and investor in the biotechnology and diagnostics sectors.

The ReconAAsense trial, Mainz Biomed's pivotal FDA PMA clinical trial, aims to evaluate a next-generation CRC screening test incorporating novel gene expression biomarkers. Recent clinical studies have shown promising results, indicating high sensitivity and specificity for both CRC and Advanced Adenoma. With approximately 15,000 subjects across 150 sites in the U.S., ReconAAsense aims to establish the efficacy and accuracy of Mainz Biomed's innovative diagnostic solution.

Mainz Biomed's flagship product, ColoAlert®, offers a non-invasive and user-friendly CRC screening kit that has achieved commercial success in select European markets. With plans to expand its presence in the U.S. through ReconAAsense, the company aims to address the significant market opportunity presented by the growing demand for effective CRC screening solutions.

Colorectal cancer remains a significant global health challenge, with Mainz Biomed at the forefront of efforts to improve early detection and treatment outcomes. Through strategic partnerships and innovative technology, the company is poised to make a meaningful impact in the fight against CRC, ultimately saving lives and improving public health worldwide.

 

Source: globenewswire.com

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