BERKELEY, Calif. and MAINZ, Germany - Mainz Biomed N.V. (NASDAQ:MYNZ), a molecular genetics diagnostic company, has announced significant findings from a pooled clinical study on colorectal cancer (CRC) screening. The study's topline results showcased a sensitivity of 92% and a specificity of 90% for CRC detection, alongside an 82% sensitivity for advanced adenoma, which the company states is best-in-class.
The study analyzed 690 subjects, including new patients from Mainz Biomed's ColoFuture and eAArly DETECT trials across 30 clinical sites in the U.S. and Europe. These subjects were evaluated using the company's novel mRNA biomarkers, a fecal immunochemical test (FIT), and a proprietary AI algorithm.
Guido Baechler, CEO of Mainz Biomed, expressed that the results mark a critical milestone towards their upcoming FDA PMA pivotal study, ReconAAsense, aiming to recruit up to 15,000 patients. The study's findings are planned to be published at a major medical conference in the second quarter of 2024.
The Centers for Disease Control and Prevention (CDC) recognizes CRC as the second most lethal cancer in the U.S. and Europe. However, it is also considered the most preventable, with early detection leading to survival rates above 90%. Mainz Biomed's mRNA biomarkers have previously demonstrated the ability to detect CRC lesions, including advanced adenomas, which are pre-cancerous polyps.
The company's flagship product, ColoAlert®, is a user-friendly, at-home CRC screening kit, which is commercially available in select EU countries. The product's effectiveness is based on PCR technology, and it is currently undergoing a pivotal FDA clinical study for U.S. regulatory approval.
This announcement is based on a press release statement from Mainz Biomed.
InvestingPro Insights
Mainz Biomed N.V. (NASDAQ:MYNZ) has shown promise with its recent clinical study results, but the financial metrics from InvestingPro paint a picture of a company that may face challenges ahead. With a market capitalization of $19.67 million and a negative Price/Earnings (P/E) ratio of -0.73 for the last twelve months as of Q4 2023, investors should be aware of the company's current lack of profitability. The high Price/Book ratio of 6.05 suggests that the stock is trading at a significant premium relative to the company's book value.
The company's revenue has grown by 69.0% over the last twelve months as of Q4 2023, indicating some potential in its operations. However, Mainz Biomed is trading at a high revenue valuation multiple, which could be a concern for value-focused investors. The company does not pay a dividend, which is not uncommon for companies focused on growth and reinvestment, but it is a factor for those seeking income from their investments.
According to InvestingPro Tips, Mainz Biomed is quickly burning through cash and analysts do not anticipate the company will be profitable this year. This is crucial information for investors considering the stock, especially in light of the company's moderate level of debt. For those seeking more detailed analysis, there are additional InvestingPro Tips available, including insights on the stock's significant price fall over the last year and its valuation multiples. Interested investors can uncover more tips by visiting https://www.investing.com/pro/MYNZ and can use the coupon code PRONEWS24 to get an additional 10% off a yearly or biyearly Pro and Pro+ subscription.
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