Monday, July 15, 2024

Colorectal Cancer Test: Mainz Biomed Seeks FDA Breakthrough Device Status

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Colorectal cancer (CRC) screening test has been recently submitted by Mainz Biomed for breakthrough device designation to the US Food and Drug Administration (FDA). This next-generation, non-invasive test, which integrates new mRNA biomarkers, aims to expedite approval and bring a highly effective screening tool to market sooner.

The submission to the FDA is supported by robust clinical data from the ColoFuture and eAArly Detect studies, along with pooled data from both the European and US arms of the trials presented at the American Society of Clinical Oncology (ASCO) 2024 conference. The results have been promising, leading Mainz Biomed to finalize the configuration of its Next Generation Test, which combines the faecal immunochemical test (FIT) with advanced mRNA biomarkers.

Advancing Non-Invasive Colorectal Cancer Screening: High Efficacy in Clinical Trials

In a clinical trial involving 295 participants from 21 specialized gastroenterology centers across the United States, the test demonstrated significant efficacy. It reported a sensitivity of 97% for detecting CRC and 88% for advanced precancerous lesions, with a specificity of 93%. These metrics indicate a high degree of accuracy in identifying both colorectal cancer and advanced adenomas, setting a new standard for non-invasive CRC screening.

The Next Generation Test by Mainz Biomed incorporates advanced AI and machine learning algorithms, enhancing its diagnostic capabilities. These innovations were part of the FDA premarket approval study, underscoring the sophisticated technological foundation of the test. The integration of AI allows for more precise differentiation between CRC, advanced adenomas, non-advanced adenomas, and samples without pathological findings.

Guido Baechler, CEO of Mainz Biomed, expressed optimism about the clinical results and the future impact of the test. “On the back of our extremely positive clinical results in all our recent studies, finalizing the test which will be used in the pivotal ReconAAsense study and approval process has been an elementary milestone for our company,” Baechler stated. He emphasized that the test’s significant improvement in sensitivity for advanced adenomas and high-grade dysplasias, coupled with its high sensitivity and specificity for CRC, represents a major advancement in CRC screening.

Colorectal Cancer

Decentralized Access and Enhanced Adherence: Mainz Biomed’s Strategy for Colorectal Cancer Screening

Baechler also highlighted the strategic advantages of the test’s decentralized model. By collaborating with third-party laboratory partners, Mainz Biomed aims to enhance access to CRC screening, especially in underserved communities. The simple sample collection process is designed to increase adherence to testing, further broadening the test’s impact.

If granted breakthrough device designation, Mainz Biomed’s test could revolutionize CRC screening by providing a highly accurate, non-invasive alternative to traditional methods. The high sensitivity and specificity metrics mean that more cases of CRC and advanced precancerous lesions can be detected early, potentially improving patient outcomes and reducing mortality rates associated with colorectal cancer.

The test’s design allows it to fit seamlessly into existing healthcare frameworks, leveraging advanced technology to offer a reliable, easy-to-administer screening option. This is particularly important in a landscape where early detection of colorectal cancer is critical to effective treatment and survival.

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Mainz Biomed’s pursuit of FDA breakthrough device status for its Next Generation Test marks a significant step forward in the fight against colorectal cancer. With its impressive clinical results, innovative use of AI and mRNA biomarkers, and a model designed to reach underserved populations, the test promises to enhance early detection and improve patient outcomes. As the FDA reviews the application, the medical community and patients alike await the potential approval of a game-changing tool in CRC screening.


Resource: Mainz Biomed, July 09, 2024

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