Mainz Biomed, a molecular genetics diagnostic company specialising in the early detection of cancer, has entered into a Technology Rights Agreement with Socpra Sciences Santé Et Humaines S.E.C. (“TTS”) to access a portfolio of novel mRNA biomarkers for potential future integration into ColoAlert, the company’s detection test for colorectal cancer (“CRC”).
Mainz is currently marketing ColoAlert in Europe through its unique business model of partnering with third-party laboratories for test kit processing versus the traditional methodology of operating a single facility. The company is also preparing to initiate ColoAlert’s regulatory pathway for approval in the United States.
Under the terms of the Technology Rights Agreement, the company has the unilateral option to license the exclusive global rights to five gene expression biomarkers which have demonstrated a high degree of effectiveness in detecting CRC lesions including advanced adenomas (“AA”), a type of pre-cancerous polyp often attributed to this deadly disease. In a study evaluating these biomarkers published in the online peer review journal platform MDPI (March 11, 2021), study results achieved overall sensitivities of 75% for AA and 95% for CRC, respectively, for a 96% specificity outcome. If these statistical results are duplicated when the biomarkers are integrated into ColoAlert, we believe that it will ultimately position the company’s CRC test to be the most robust and accurate at-home diagnostic screening test on the market. It will not only detect cancerous polyps with a high degree of accuracy but has the potential to prevent CRC through early detection of precancerous adenomas.
Guido Baechler, chief executive officer of Mainz Biomed, said: “Securing the exclusive rights to license this family of novel biomarkers is a fantastic milestone for the company as it provides an extraordinary opportunity to potentially upgrade ColoAlert’s technical profile, possibly making it the most effective at-home screening test for CRC that has ever been commercialised. The Mainz team is on a mission to develop gold standard molecular diagnostic screening solutions for cancer indications and obtaining the rights to these biomarkers is a testament to our on-going commitment to develop cutting-edge products as they have shown superior sensitivity to even liquid biopsy products in development in terms of identifying advanced adenomas.”
The company will now commence a clinical study in Europe to evaluate the effectiveness of these biomarkers to enhance ColoAlert’s utility in terms of extending its capability to include the identification of advanced adenomas, while increasing rates of diagnostic sensitivity and specificity. Given ColoAlert in its present form has already been CE-IVD marked (complying with EU safety, health, and environmental requirements), the timeline and process to initiate this “add-on” study is expedited, and the company is targeting the first half of 2022 to launch the clinical study. Data generated by the study may be incorporated into the company’s design of ColoAlert’s U.S. clinical trial for consideration by the FDA.
