- European Study ColoFuture and U.S. Study eAArly DETECT report sensitivity and specificity for the detection of Colorectal Cancer and Advanced Adenoma exceeding competition
- ReconAAsense designed to evaluate gold standard at-home colorectal cancer screening test and is on track to commence enrollment in mid-2024
- Expanded international commercialization of ColoAlert® in major European markets and Israel
BERKELEY, Calif. and MAINZ, Germany, Jan. 09, 2024 (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 a year end summary of its corporate and product development progress.
Key Commercial, Product Development and Operational Highlights Included:
- Announced groundbreaking results from ColoFuture (Europe) and eAArly DETECT (U.S.) clinical studies evaluating the potential to integrate portfolio of novel gene expression (mRNA) biomarkers into a next-generation version of ColoAlert®.
- ColoFuture reported sensitivity for colorectal cancer (CRC) of 94% with specificity of 97% and advanced adenoma (AA) sensitivity of 80%.
- eAArly DETECT reported sensitivity for CRC of 97% with a specificity of 97% and a sensitivity for AA of 82%.
- Expanded international commercialization of ColoAlert®, a highly efficacious and easy-to-use DNA-based detection test for CRC being sold via Company’s unique business model of marketing products via partnerships with third-party laboratories versus the traditional methodology of operating a single facility.
- Established commercial operations in major markets including Spain, Poland, Romania, Portugal, Israel, and the UK.
- Launched corporate health program with Germany serving as initial market via integration into Country’s BGM system (“betriebliches Gesundheitsmanagement”).
- Ramped-up preparations for pivotal FDA PMA clinical trial (ReconAAsense) which remains on track to commence patient enrollment in mid-2024. Presents an opportunity to achieve gold-standard status for at-home CRC screening.
“This past year was an exceptional period for the Company as we executed our international commercial strategy for flagship product ColoAlert® while advancing product development programs,” commented Guido Baechler, Chief Executive Officer of Mainz Biomed. “The latter half of 2023 was especially exciting given the groundbreaking results from the ColoFuture and eAArly DETECT studies which reported extraordinary statistical significance for CRC lesion detection and advanced adenomas, a type of pre-cancerous polyp often attributed to this deadly disease. This outstanding outcome enables optimal trial design for the ReconAAsense pivotal FDA PMA study that if successful, will now represent disruptive innovation in self-administered CRC screening, providing the opportunity to bring to market the most advanced diagnostic tool on the market. As such, we head into 2024 with a great deal of momentum as we make final preparations for ReconAAsense, with patient enrollment targeted to commence mid-year. On the commercial front, we’ll continue to expand our international footprint while strengthening our presence in established markets.”
2023 Commercial Summary: Expanded international partnership network and increased presence in established markets.
Throughout 2023, Mainz Biomed executed its differentiated commercial plan of partnering with third-party laboratories for test kit processing versus the traditional methodology of operating a single facility. Under the standard terms of all partnerships, Mainz Biomed is providing ColoAlert® to the respective labs, including co-branding with key accounts, whereby each facility purchases Mainz Biomed’s customized polymerase chain reaction (PCR) assay kits on an on-demand basis and provides their respective network of physicians and patients with a comprehensive solution for advanced CRC detection. During the year, Mainz Biomed expanded its commercial operations in major international territories by extending its network of laboratory and distribution partners while continuing to gain traction in established markets.
During the year, Mainz Biomed launched commercial operations in Spain, Portugal, Romania, Poland, the United Kingdom, and Israel. For Spain and Portugal, the Company established a partnership with The Instituto de Microecologia, widely known for its pioneering work in intestinal health. The laboratory offers a wide range of diagnostic and analytical services and is continuously advancing its scientific and technical capabilities through ongoing internal research alongside external collaborations. The Institute deploys the most innovative diagnostic techniques by continuously auditing procedures…
Read More: Mainz Biomed Provides Year-End Corporate Review 2023