Mainz Biomed Seeks FDA Approval for Advanced Colorectal Cancer Test

Colorectal cancer remains a formidable health challenge, being the second leading cause of cancer-related deaths in the United States with more than 100,000 cases diagnosed so far in 2024. Mainz Biomed (NASDAQ: MYNZ), a German company with U.S. offices in Berkeley, California, is working on a new test that could drastically improve early detection rates.

Standard methods for detecting colorectal cancer, such as colonoscopies and fecal immunochemical tests (FIT), have their limitations. Colonoscopies are invasive and unpleasant, while FITs, which analyze DNA to detect pre-cancerous polyps, have moderate sensitivity levels. Blood-based tests have also been met with skepticism due to their lower effectiveness and cost-efficiency.

Mainz Biomed has developed a molecular diagnostic test that utilizes mRNA biomarkers to identify colon cancer risk. The company recently submitted an application to the U.S. Food and Drug Administration (FDA) for Breakthrough Device Designation for this non-invasive product. Studies conducted by Mainz have demonstrated that their mRNA-powered test has double the sensitivity for detecting precancerous polyps compared to existing products.

According to Mainz CFO Bill Caragol, current competitors' tests show efficacy in detecting advanced adenomas in the 40% range, while Mainz's test consistently exceeds 80% accuracy. This substantial increase in sensitivity could mean that Mainz's ColoAlert® test misses up to 60% fewer cases than its competitors.

The next-generation FIT test employs artificial intelligence and machine learning to enhance the detection of early warning signs of colorectal cancer. Mainz is set to conduct an FDA pre-market approval study in 2025, aiming to distribute the test through a network of FDA-approved national reference laboratories. This distribution strategy differs from current market practices, where companies control the entire testing process.

Mainz's approach involves strategic partnerships with PCR providers and national reference labs, essential for both the FDA study and the commercial launch if approved. These partnerships will support Mainz's goal of integrating its test into the largest distribution networks and raising awareness among healthcare professionals about its benefits.

The market for colorectal cancer screening in the U.S. is valued at over $30 billion annually, with global figures doubling this amount. Mainz's successful FDA approval and subsequent commercial launch could pave the way for future product expansions, including test kits for pancreatic and other gastrointestinal cancers, significantly broadening its market reach.

The potential for Mainz Biomed's new colorectal cancer test to set a new gold standard in non-invasive screening is substantial. With enhanced sensitivity and a strategic distribution plan, Mainz is poised to make a significant impact on early cancer detection and patient survival rates.

For more information about Mainz Biomed listen to the conversation Bill Caragol had with Benzinga’s Zunaid Suleman.