By James Blacker , Benzinga

Mainz Biomed NV (NASDAQ: MYNZ), a company that specializes in the early detection of cancer, recently shared encouraging topline results from a clinical study designed to test the next-generation version of its colorectal cancer screening tool, ColoAlert®.

The company recently unveiled compelling findings from its most expansive group to date at the 2024 Annual Meeting of the American Society of Clinical Oncology (ASCO) in Chicago, Illinois, as well as virtually. The comprehensive examination consisted of 690 participants from 30 reputable gastroenterology facilities in Europe and the United States, and introduced previously unexplored and unreported specimens.

The results underscored the effectiveness of Mainz Biomed's multimodal screening test, marking significant advancements in colorectal cancer detection. Notable figures include a sensitivity of 92.3% for colorectal cancer, a specificity of 90.1%, a sensitivity rate of 82.2% for advanced precancerous lesions, and an impressive high-grade dysplasia detection rate of 95.8%.

With the success of this study, Mainz Biomed now plans to move forward with a major clinical trial in the U.S., which will involve up to 15,000 participants. If this next trial produces positive results, the company says its next-generation tool has the potential to disrupt the at-home colorectal cancer screening market by becoming a new gold standard.

“The new data read-out demonstrates that our next generation product candidate for early-stage CRC detection utilizing mRNA biomarkers, a FIT test and a proprietary AI algorithm has consistently delivered high sensitivity and specificity for both advanced adenomas and colorectal cancer,” said Guido Baechler, CEO of Mainz Biomed, “These results represent a critical milestone on our path to launching our FDA PMA pivotal study ReconAAsense, which is planned to recruit up to 15,000 patients.”

According to the American Cancer Society’s latest publication, the incidence of colorectal cancer has increased alarmingly since the mid-1990s, continuing to rise between 1% and 2% each year in people under the age of 55. Since the mid-2000s, the mortality rate among young people has increased at a similar rate.

Colorectal cancer is the third most common cancer worldwide and the second leading cause of cancer-related deaths worldwide. However, it is also the most preventable, with early detection leading to survival rates above 90%.

Founded in Germany, Mainz Biomed is becoming a leading global provider of easy-to-use diagnostic solutions for patients and healthcare providers everywhere. The company develops market-ready molecular genetic diagnostic solutions for life-threatening conditions. It is involved in the commercializing of its product portfolio in Europe, the United States and the rest of the world, and develops innovative products to quickly and reliably identify the early onset of several leading deadly conditions – such as pancreatic cancer and colorectal cancer.

The company reports that its CE-IVD-cleared flagship product, ColoAlert, is the first DNA-based screening test for colorectal cancer in Europe, and that it is developing proprietary genetic testing methods for pancreatic cancer.

For 2023, the company earned revenues of $895,479, which compared to revenues of $529,877 in 2022.

In a market with established players such as Cologuard from Exact Sciences Corporation (NASDAQ: EXAS), ColoAlert stands out as an innovative product that addresses the need for a convenient and user-friendly test.

Mainz Biomed claims that ColoAlert is not only more effective than traditional blood tests at detecting precancerous polyps early but also detects more cases of colorectal cancer than other stool tests.

As Mainz Biomed plans its upcoming major trial in the U.S., the company could be one to watch as a force in the fight against cancer.

More information about the company can be found at mainzbiomed.com.

Featured photo by Gerd Altmann on Pixabay.

Benzinga is a leading financial media and data provider, known for delivering accurate, timely, and actionable financial information to empower investors and traders.

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