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Mainz Biomed Partners with German Regional Lab on Colorectal Cancer Test Commercialization

NEW YORK – German diagnostics firm Mainz Biomed said Monday that it has partnered with Laboratory Mönchengladbach MVZ Dr. Stein & Kollegen, a large regional laboratory that is part of the Limbach Group laboratory network, to expand the commercial reach of its ColoAlert, a colorectal cancer early detection assay.

Under the terms of the partnership, Mainz Biomed will co-brand ColoAlert with Laboratory Mönchengladbach and sell its PCR assay kits on an on-demand basis for use by the more than 2,500 physicians served by the lab.

ColoAlert combines analysis of DNA for specific tumor markers with the fecal immunochemistry test. It is currently CE-IVD marked, and Mainz said it is working on transitioning to compliance with IVDR.

The companies are also collaborating on marketing and education campaigns for the test, including direct-to-consumer advertising.

Financial terms of the deal were not disclosed.

"As a result of our unique model of engaging in mutually beneficial commercial partnerships … we are ideally positioned to further scale operations across Europe and will continue to pursue and engage in beneficial partnerships with the leading diagnostics labs in each jurisdiction being targeted," Mainz CEO Guido Baechler said in a statement.

Other partnerships include a recent, similar agreement with Ganzimmun Diagnostics.

According to Mainz, Laboratory Mönchengladbach already screens approximately 1,000 patients per week for CRC.

"As an organization focused on delivering the very best diagnostics solutions to our network, we've been highly impressed by the efficacy of the ColoAlert test. We're thrilled to be able to make it available to patients via their physicians across the region and catch more cases of this deadly disease in its earliest stages where it can be successfully treated," Dietmar Dressen, managing director of Laboratory Mönchengladbach, said in a statement.