The clinical genome-wide DNA methylation test can diagnose genetic diseases that are missed by exome or genome sequencing and evaluate variants of unknown significance.
The company's assay relies on a set of 15 methylation and microRNA markers to determine whether a woman has breast cancer.
As part of the agreement, LifeLabs will serve as an exclusive distributor for MDxHealth's non-invasive liquid biopsy prostate cancer assay In Canada.
Led by investigators at the University of Trento in Italy, the team received a five-year, £5 million ($6.4 million) award recently to advance its work.
Investigators shared data at an oncology meeting last week, showing that the test has high sensitivity and specificity in a blinded case-control cohort that included early-stage tumors.
The firm plans to conduct a prospective trial of a pan cancer assay and aims to bring another assay focused on colorectal cancer through FDA clearance.
The test uses changes in DNA methylation patterns for the early detection of lung cancer and is based on the same platform as the firm's bladder cancer test.
The final LCD, which expands Medicare coverage of the firm's ConfirmMDx test to all providers, becomes effective on Sept. 3.
The firm has been developing several new tests that are based on its ADAPT aptamer profiling technology.
The Belgian company recently received €3.6 million to develop the signature into a clinical test within the next three years.