Mainz Biomed N.V., a molecular genetics diagnostic company specializing in early cancer detection, has unveiled the significant findings of its ColoFuture Study. The study was initially set for presentation at the 4th International Conference on Gastroenterology in Paris but was rescheduled. Despite the change, Mainz Biomed decided to release the results as per the original conference timeline.
- The ColoFuture study was an international clinical trial that evaluated the integration of novel gene expression (mRNA) biomarkers into ColoAlert®, Mainz Biomed’s screening test for colorectal cancer (CRC). This test is being commercialized across Europe and in select international regions.
- The study’s results showcased a sensitivity for CRC of 94% with a specificity of 97%. Additionally, the sensitivity for advanced adenoma (AA) was 80%.
- ColoAlert® is a non-invasive CRC screening kit that offers high sensitivity and specificity. It can indicate tumors by analyzing tumor DNA, providing better early detection than fecal occult blood tests (FOBT). The product is available in select EU countries and is undergoing an FDA-registration trial for US approval.
- Colorectal cancer is the third most common cancer worldwide. In the US, screening recommendations suggest using stool DNA tests like ColoAlert® every three years starting at age 45.