Germany-based molecular genetics diagnostic company Mainz Biomed has partnered with US-based diagnostic information services provider Quest Diagnostics.
The collaboration aims to support the commercialisation of Mainz Biomed’s next-generation stool-based screening test for colorectal cancer, dubbed ColoAlert.
Under the partnership, Quest will provide clinical trial laboratory services for Mainz Biomeds’s ReconAAsense study to validate the test for FDA approvals.
The clinical study will include 15,000 subjects from 150 sites across the US.
Once the test gets FDA approval, Quest can exercise semi-exclusive rights to provide testing services based on the test kit for a period of 18 months.
Mainz Biomed CEO Guido Baechler said: “We are excited by the opportunity to work with Quest Diagnostics.
“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.”
According to the World Cancer Research Fund, Colorectal cancer (CRC) is the world’s third most common cancer, with more than 1.9 million new cases reported in 2020.
The US Preventive Services Task Force recommends screening with stool DNA-FIT (sDNA-FIT) tests once every one to three years, starting at age 45.
Mainz Biomed designed the ColoAlert test to detect colorectal cancer tumour DNA to help identify colorectal cancer in its early stages.
The test leverages polymerase chain reaction (PCR) technology on a small sample of DNA from the patient’s stool sample to identify genetic mutations that may lead to cancer.
In addition, ColoAlert test has shown promising sensitivity and specificity in identifying colorectal cancer, including advanced adenomas, in preliminary data.
Earlier this year, Quest Diagnostics partnered with Augurex Life Sciences, a Canada-based biotechnology company to enhance rheumatoid arthritis (RA) diagnosis and management.
