In preliminary data, the test has demonstrated ‘promising’ specificity and sensitivity in detecting early-stage colorectal cancer. Credit: Jo Panuwat D/Shutterstock

Mainz Biomed has announced a partnership with Quest Diagnostics to support the commercialisation of its NextGen colorectal cancer screening test, ColoAlert.

The test leverages polymerase chain reaction (PCR) technology to detect cancerous DNA in stool samples and is poised to enhance early detection of this malignancy.

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In preliminary data, the test has demonstrated ‘promising’ specificity and sensitivity in detecting early-stage colorectal cancer and advanced adenomas.

Quest Diagnostics will facilitate clinical trial laboratory services for Mainz Biomed’s ReconAAsense study, which aims to enrol nearly 15,000 individuals from 150 sites across the US. It is a prospective clinical trial designed to provide data supporting the Food and Drug Administration (FDA) validation of the test.

Additionally, Mainz Biomed will grant Quest the option to exercise semi-exclusive rights to offer testing services based on the ColoAlert test kit, contingent upon FDA approval, for a duration of 18 months.

Mainz Biomed CEO Guido Baechler said: “We are excited by the opportunity to work with Quest Diagnostics.

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“Quest is a leader in cancer diagnostics and knows how to scale these innovations to make them broadly accessible to patients in need. 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.”

The non-invasive test is already marketed across Europe and the United Arab Emirates.

In May 2023, the company entered a commercial partnership with TESTDNA to distribute ColoAlert in Poland.

Colorectal cancer is the third most common cancer worldwide. The US Preventive Services Task Force recommends regular screening starting at age 45.

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