Mainz Biomed Seeks FDA Approval For Colorectal Cancer Test It Says Is Nearly Twice As Sensitive As Others – A Look At Pipeline And Milestones

In August 2020, popular actor Chadwick Boseman succumbed to colorectal cancer at the age of 43 after a four-year battle with colon cancer. The untimely death of the Black Panther star saw many fans overcome with grief but also brought attention to the danger posed by such cancers.

Colorectal cancer is the second leading cause of cancer death in the United States, with more than 100,000 cases diagnosed so far in 2024. Mainz Biomed MYNZ, a German company whose U.S. offices are in Berkeley, California, believes the threat can be mitigated by technology and is working on a predictive test that may be more effective than solutions currently on the market.

Benzinga recently sat down with the company's CFO, Bill Caragol, to discuss the challenge and all the work the company is doing to help address it.

The Available Options For Detecting Colorectal Cancer

The standard of care for detecting colorectal cancer has since 1969 been the colonoscopy. The procedure is invasive and not very pleasant.

In 2014, the fecal immunochemical test (FIT) received FDA approval. The test analyzes a person's DNA to detect advanced adenomas, the pre-cancerous polyps that "may be the most valid…marker for present and future colorectal cancer risk," according to research published by the National Library of Medicine.

Blood-based tests are also available to detect colorectal cancer risk. However, some in the medical community are cautious about their use. According to David Lieberman, MD, chair of the American Gastroenterological Association's Colorectal Cancer Workshop, "blood tests are neither as effective or cost-effective” as established colorectal cancer screening tests – something that Mainz's Caragol testifies to, as well, stating that doctors continue to prescribe stool-based tests over blood tests because of the clinical differentiation since stool-based tests are better at detecting early-stage cancer, despite the "yucky factor."

He added,"Remember, [with] colorectal cancer – you detect late-stage, there's a roughly 10% survival. When you catch it in early-stage, there's 90% survival."

Mainz's Breakthrough Device Leads To Next-Generation Screening Test

Mainz has developed a molecular diagnostic solution to detect colon cancer risk. 

In July, Mainz submitted an application to the U.S. Food and Drug Administration (FDA) requesting Breakthrough Device Designation for a non-invasive colorectal cancer product that includes a portfolio of mRNA biomarkers.

Studies conducted by Mainz revealed that its mRNA-powered test showed a sensitivity for detecting precancerous polyps that is double that of products currently on the market.

In those studies, competitors' tests "demonstrated efficacy of detecting advanced adenomas in the 40% range," says Bill Caragol.

Caragol added that readouts from the three clinical studies Mainz conducted between 2023 and 2024, "demonstrated consistent accuracy above 80%, a quantum leap…over the other stool-based tests."

Mainz says its flagship product, ColoAlert®, misses far fewer cases than its competitors' tests. Mainz puts the number at up to 60% fewer cases. Its next-generation FIT test is an enhancement of ColoAlert and was submitted to the FDA in July for Breakthrough Device designation.

The next-generation FIT test is complemented by a proprietary algorithm that uses artificial intelligence and machine learning to identify mRNA biomarkers in order to better detect the early warning signals of potential colorectal cancer.

Mainz said the test is "a new gold standard for noninvasive detection of advanced adenomas." The company is scheduled to conduct an FDA pre-market approval study in 2025 for its next-generation test.

A focus of the study is to distribute the next-generation test kit through the currently existing network of FDA-approved national reference testing laboratories in the United States. This differs from other products currently on the market in that the companies that make those test kits also control the testing process.

As Caragol describes it, "every test [is] manufactured by them, sent out by them, returned to them [for analysis], test results delivered." As a result, says Caragol, Mainz will have "the only product that will fit into the largest distribution."

Milestones Mainz Is Focused On For The Year Ahead

Mainz has a clear strategy for approaching the market. Caragol said that they realize that as a small company targeting a large market, they will have to strategically align themselves with larger companies.

The company is looking to partner with a PCR provider as well as one of the national reference labs. PCR labs specialize in blood, urine and other molecular testing to detect pathogens, commonly used for diagnosing infections like COVID-19. National reference labs offer a wide range of high-accuracy diagnostic services, including PCR, serving as centralized hubs for specialized testing across various locations.

Having these partnerships in place is necessary for Mainz to conduct its FDA pre-market approval study. Importantly, they will also be important allies if the company receives approval to sell the kits. They will be integral components of Mainz's commercial go-to-market strategy.

At that point, Mainz's commercial roadmap will focus on creating partnerships and awareness within physician networks and health care professionals about the differentiating benefits of the ColoAlert mRNA powered test.

Investment Drivers For Companies Like Mainz Biomed

If the company can meet each of its milestones, then it could set a course for future growth. The U.S. market for colorectal screening "is over $30 billion a year," according to Caragol. He notes that the market is double that worldwide.

There are a number of companies competing domestically for colorectal screening, the most notable of which is Exact Sciences Corp. EXAS. Caragol says Exact has about a 10% share of U.S. sales.

As such, there may be an opportunity for Mainz if its next-generation test receives FDA approval in the next few years.

The company says that a successful launch could open the door to other products, including test kits for pancreatic and other gastrointestinal cancers – significantly expanding its addressable market.

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

Featured photo by Furiosa-L from Pixabay.

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