Research analysts covering MAINZ BIOMED.
Recent press releases and 8-K filings for MYNZ.
Mainz Biomed Reviews 2025 Accomplishments and Outlines 2026 Plans
MYNZ
Product Launch
New Projects/Investments
Guidance Update
- Mainz Biomed reviewed its major accomplishments for 2025, highlighted by the initiation of the eAArly DETECT 2 U.S. clinical study for its next-generation colorectal cancer test, a precursor to the ReconAAsense U.S. FDA pivotal trial.
- The company significantly expanded the market reach of its ColoAlert® colorectal cancer screening test, securing official registration in the United Kingdom and Switzerland, and establishing partnerships for distribution in Switzerland and South America.
- For its pancreatic cancer project, Mainz Biomed reported positive topline results from an October 2025 feasibility study, showing 100% sensitivity and 95% specificity for a non-invasive blood-based screening test, and received public funding for its development.
- The company anticipates completing the eAArly DETECT 2 study and launching the ReconAAsense US FDA pivotal colorectal cancer study in the first half of 2026, alongside further advancements in its blood-based pancreatic cancer screening test.
Jan 5, 2026, 2:15 PM
Mainz Biomed Reports Positive Feasibility Study Results for Pancreatic Cancer Test
MYNZ
New Projects/Investments
- Mainz Biomed announced positive topline results from a feasibility study for a non-invasive blood-based screening test for the early detection of pancreatic cancer.
- The leading biomarker panel achieved 100% sensitivity and 95% specificity in a 30-subject cohort, successfully distinguishing pancreatic cancer patients from healthy controls.
- The algorithm developed by Liquid Biosciences also successfully detected precancerous lesions, opening the door for earlier monitoring and intervention.
- Following these results, Mainz Biomed plans a larger clinical study to finalize biomarker selection and a subsequent validation study, which could lead to a future submission to the U.S. Food and Drug Administration (FDA).
Oct 8, 2025, 1:01 PM
Mainz Biomed to Present RNA-based Colorectal Cancer Screening Data at WEO Meeting
MYNZ
New Projects/Investments
- Mainz Biomed (NASDAQ:MYNZ) will participate in the World Endoscopy Organization's (WEO) Colorectal Cancer (CRC) Screening Committee Plenary Meeting on October 3rd, 2025, in Berlin, Germany.
- Dr. Lena Krammes will present clinical data from the 2024 eAArly DETECT study, showcasing the potential of stool RNA testing to identify colorectal cancer and precancerous lesions.
- Key findings from the study include 97% sensitivity and 97% specificity for detecting colorectal cancer, 82% sensitivity for advanced adenomas, and 100% detection of advanced adenomas with high-grade dysplasia.
- These results highlight the potential for RNA-based testing in both early detection and prevention of CRC, as Mainz Biomed continues its eAArly DETECT 2 clinical study in preparation for pivotal FDA study for US regulatory approval.
Sep 30, 2025, 12:03 PM
Mainz Biomed's ColoAlert Authorized for Marketing in UK
MYNZ
Product Launch
New Projects/Investments
- Mainz Biomed's ColoAlert® has received official registration with the Medicines and Healthcare products Regulatory Agency (MHRA), authorizing its marketing in the United Kingdom.
- This approval enables the company's UK laboratory partner, EDX Medical Group plc, to provide the DNA-based colorectal cancer screening test across the UK.
- The authorization supports the expansion of access to early cancer detection solutions and aims to complement the existing Bowel Cancer Screening Program in the UK, where colorectal cancer is the fourth most common cancer.
Sep 2, 2025, 12:03 PM
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