NEW YORK – Quest Diagnostics and Mainz Biomed said Thursday they have entered an agreement for Quest to provide clinical trial lab services for Mainz Biomed's ColoAlert colorectal cancer screening test.
Under the agreement, Quest will provide clinical trial services for Mainz's Biomed's ReconAAsense study, a prospective clinical study that will include approximately 15,000 subjects from 150 sites across the United States to develop data supporting a US Food and Drug Administration submission for the ColoAlert test.
Quest will also have the option to obtain semi-exclusive rights to provide ColoAlert testing services for an 18-month period if the test receives FDA approval.
Financial and other terms of the agreement were not disclosed.
ColoAlert uses PCR to detect genetic mutations linked to colorectal cancer in patient stool samples.
"Quest is a leader in cancer diagnostics and knows how to scale these innovations to make them broadly accessible to patients in need," Mainz Biomed CEO Guido Baechler said in a statement. "With their support, we are positioned to advance commercial development of our ColoAlert test in order to help more patients gain access to quality screening."