Mainz Biomed has announced that it has made an agreement with Quest Diagnostics in which Quest will support the commercialization of Mainz Biomed’s next-generation ColoAlert colorectal cancer (CRC) screening test.
Under the terms of the agreement, Quest will provide clinical trial laboratory services for Mainz Biomeds’ ReconAAsense study, a prospective clinical study that includes approximately 15,000 subjects from 150 sites across the U.S. intended to provide data in support of the test’s submission for U.S. Food and Drug Administration (FDA) approval, Mainz said in a statement.
Assuming the test’s FDA approval, Quest will have the option to exercise semi-exclusive rights to provide testing services based on the test kit for 18 -months.
Financial terms of the agreement were not disclosed.
Mainz Biomed’s stool-based ColoAlert test uses polymerase chain reaction (PCR) technology to detect CRC tumor DNA to help identify genetic mutations that may lead to a CRC diagnosis in its early stages. In preliminary data, the test has shown promising sensitivity and specificity in identifying CRC, including advanced adenomas, the firm said.