Mainz Biomed Advances Colorectal Cancer Detection with Innovative mRNA Test

Mainz Biomed (NASDAQ: MYNZ), a German biotech company with U.S. offices in Berkeley, California, is making strides in the fight against colorectal cancer with a new screening test that could potentially revolutionize early detection. The company has submitted an application to the U.S. Food and Drug Administration (FDA) for Breakthrough Device Designation for its non-invasive colorectal cancer product, which utilizes a portfolio of mRNA biomarkers.

Colorectal cancer remains a significant health concern, with over 100,000 cases diagnosed in the United States so far in 2024. It is the second leading cause of cancer death in the country, highlighting the critical need for improved screening methods. Mainz Biomed's innovative approach aims to address this pressing issue by offering a more sensitive and accurate detection method.

The company's flagship product, ColoAlert®, and its next-generation FIT test have shown promising results in clinical studies. According to Bill Caragol, Mainz Biomed's CFO, their mRNA-powered test demonstrated a sensitivity for detecting precancerous polyps that is double that of products currently on the market. In studies conducted between 2023 and 2024, the test consistently achieved accuracy rates above 80%, which Caragol describes as "a quantum leap...over the other stool-based tests."

Mainz Biomed claims that its test misses up to 60% fewer cases than competing tests. This significant improvement in detection rates could have a substantial impact on survival rates. As Caragol points out, "When you catch it in early-stage, there's 90% survival," compared to only a 10% survival rate for late-stage detection.

The company's next-generation FIT test incorporates a proprietary algorithm that uses artificial intelligence and machine learning to identify mRNA biomarkers, enhancing its ability to detect early warning signals of potential colorectal cancer. Mainz Biomed has dubbed this test "a new gold standard for noninvasive detection of advanced adenomas."

In 2025, Mainz Biomed is scheduled to conduct an FDA pre-market approval study for its next-generation test. The company plans to distribute the test kit through existing networks of FDA-approved national reference testing laboratories in the United States. This approach differs from current market offerings, where companies typically control both the test kits and the testing process.

As part of its strategy, Mainz Biomed is seeking partnerships with PCR providers and national reference labs. These collaborations are crucial for conducting the FDA pre-market approval study and will play a vital role in the company's commercial go-to-market strategy if the test receives approval.

The potential market for colorectal screening is substantial, with Caragol estimating the U.S. market alone at over $30 billion annually and double that worldwide. If Mainz Biomed can successfully navigate the regulatory process and bring its innovative test to market, it could capture a significant portion of this lucrative industry.

The company's ambitions extend beyond colorectal cancer screening. Mainz Biomed sees the potential for expanding its technology to develop test kits for other gastrointestinal cancers, including pancreatic cancer, which could further increase its addressable market.

As Mainz Biomed progresses towards its milestones, including FDA approval and strategic partnerships, the medical community and investors alike will be watching closely. The company's innovative approach to colorectal cancer screening has the potential to make a significant impact on early detection rates and, ultimately, save lives.