NEW YORK – Mainz Biomed announced on Wednesday a partnership with German laboratory service provider Dr. Staber & Kollegen, also known as Labor Staber, to market its ColoAlert test.
The colorectal cancer screening test will be marketed through Labor Staber's network of physicians and laboratories in Germany, Mainz said in a statement. Financial and other terms of the deal were not disclosed.
"We have found putting our PCR testing kits in the hands of highly professional laboratory networks to be a much more effective business model than the traditional methodology of operating testing at a single facility," Mainz CEO Guido Baechler said in a statement.
The noninvasive test analyzes DNA, mRNA, and fecal immunohistochemistry in stool samples and is commercially available in the EU through independent laboratories, corporate health programs, and direct sales, the company said. Last month, the firm signed agreements with labs in the UK and Spain to commercialize the ColoAlert assay.
It also received approval from an independent institutional review board in December to conduct its ReconAAsense study to evaluate clinical performance of the test in the US in preparation for a submission to the US Food and Drug Administration. Once it is approved in the US, Mainz plans to partner with regional and national laboratory providers to distribute the test, the company said.