Mainz Biomed N.V. (MYNZ −5.69%), a molecular genetics diagnostic company focusing on early cancer detection, is set to present the encouraging findings from its ColoFuture study at the 4th International Conference on Gastroenterology in Paris, France. The study evaluated the integration of novel gene expression biomarkers into ColoAlert®, the company’s effective screening test for colorectal cancer.
Study Highlights:
The ColoFuture trial, conducted across multiple international centers, demonstrated promising results for the sensitivity and specificity of ColoAlert® when combined with the company’s innovative mRNA markers. Noteworthy outcomes included a 94% sensitivity and 97% specificity for colorectal cancer detection, along with an 81% sensitivity for advanced adenomas. The study involved 220 subjects from Germany, Norway, and Denmark.
Clinical Significance:
ColoAlert® stands out as a non-invasive, at-home colorectal cancer screening kit with high accuracy. By analyzing tumor DNA, it provides superior early detection compared to conventional fecal occult blood tests. The test’s PCR-based technology enables it to identify more cases of colorectal cancer, allowing for earlier diagnoses.
Presentation Details:
- Abstract: QC-ICGR23-128
- Session: Poster session, 4th International Conference of Gastroenterology, Paris, France
- Title: A novel and non-invasive mRNA and AI based early Colorectal Cancer and Advanced Adenoma detection approach – First interim data review of the international COLOFUTURE case control study
- Speaker: Dr. Moritz Eiden
Commercial Availability:
ColoAlert® is currently accessible in select EU countries through established independent laboratories, corporate health programs, and direct sales. To receive marketing approval in the US, ColoAlert® will undergo evaluation in the FDA-registration trial ‘ReconAAsense,’ with plans to establish widespread distribution in collaboration with regional and national laboratory service providers.
About Colorectal Cancer:
Colorectal cancer (CRC) ranks as the third most common cancer worldwide, necessitating timely and accurate screening. ColoAlert® addresses this need by offering a reliable, non-invasive screening option for early detection.
About Mainz Biomed N.V.:
Mainz Biomed specializes in developing market-ready molecular genetic diagnostic solutions for life-threatening conditions. ColoAlert® serves as the company’s flagship product, revolutionizing early detection of colorectal cancer. In addition to ongoing FDA clinical studies, the company’s product candidate portfolio includes PancAlert, a screening test for early-stage pancreatic cancer.
For further information, visit mainzbiomed.com or connect on LinkedIn, Twitter, and Facebook.
