Mainz Biomed Announces Submission for FDA Breakthrough Device Designation for its Next Generation CRC Screening Test

Core Insights - Mainz Biomed has submitted an application to the FDA for Breakthrough Device Designation for its non-invasive Next Generation colorectal cancer product, which includes novel mRNA biomarkers [1][4] - The Next Generation Test has demonstrated a sensitivity of 97% for colorectal cancer and 88% for advanced adenomas, with a specificity of 93% [1][4] - The test integrates a Fecal Immunochemical Test (FIT) with proprietary mRNA biomarkers and advanced AI algorithms, enhancing its diagnostic capabilities [2][3] Clinical Study Results - The configuration of the Next Generation Test was validated through a clinical study involving 295 subjects across 21 gastroenterology centers in the U.S., showcasing its efficacy in differentiating between various colorectal conditions [3] - Sensitivity for colorectal cancer is reported at 97% (95% confidence interval: 83.3-99.9), and for advanced precancerous lesions at 88% (95% confidence interval: 77.2-94.5) [4] - Specificity of the test stands at 93% (95% confidence interval: 88.4-98.3), indicating a high accuracy in identifying non-pathological samples [4] Market Opportunity - The U.S. market presents a significant opportunity, with over 16.6 million colonoscopies performed annually and approximately one-third of residents aged 50-75 never screened for colon cancer, representing a market potential exceeding $4.0 billion [6] Company Strategy - Mainz Biomed aims to transform colorectal cancer screening practices and reduce global cancer mortality rates through its decentralized model and simple collection process, which enhances access to underserved communities [11] - The company’s flagship product, ColoAlert®, is a non-invasive early-detection test for colorectal cancer, currently marketed in Europe, with plans for a pivotal FDA clinical study for U.S. regulatory approval [13]