NEW YORK – Molecular diagnostic firm Mainz Biomed announced on Wednesday that it has entered a technology rights agreement to license a portfolio of novel mRNA biomarkers from Canadian outfit Socpra Sciences Santé Et Humaines.
Under the terms of the agreement, Mainz has the unilateral option to license the exclusive global rights to five gene expression biomarkers that have demonstrated a high degree of effectiveness in detecting colorectal cancer lesions, including advanced adenomas — precancerous polyps associated with the disease.
Financial terms of the deal were not disclosed.
The biomarkers will potentially be integrated into Mainz's ColoAlert detection test for colorectal cancer, the German company said in a statement. The test analyzes cell DNA from stool for specific tumor markers, which it combines with a fecal immunohistochemistry test.
Mainz added that if and when the biomarkers are added to the test, it will "not only detect cancerous polyps with a high degree of accuracy but [it] has the potential to prevent colorectal cancer through early detection of precancerous adenomas."
Mainz said it plans to begin a clinical study in Europe in the first half of 2022 to evaluate the effectiveness of the biomarkers to enhance ColoAlert's ability to identify advanced adenomas while increasing sensitivity and specificity.
"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 commercialized," Guido Baechler, CEO of Mainz Biomed, said in a statement.
The CE-marked ColoAlert test is currently being marketed in Europe through partnerships with third-party laboratories, with preparations underway to begin the regulatory process in the US, Mainz added. Data from the clinical study in Europe may be integrated into the design of the clinical trial for US approval, Mainz noted.
Last month, Mainz signed a deal with German stool analysis lab Ganzimmun Diagnostics to commercialize ColoAlert in Germany.