NEW YORK (GenomeWeb News) - Exact Sciences will use a methylation biomarker and methylation-specific PCR technology from MDxHealth in its Cologuard non-invasive DNA colon cancer screening test, MDxHealth said today.
Exact Sciences initially licensed the marker and platform technology in July, before MDxHealth changed its name from OncoMethylome. The company has been evaluating the technology since that time.
MDxHealth said that Exact's decision to move forward with the test has triggered a milestone payment of an undisclosed amount. The company is also entitled to royalties on sales of the test once it is commercialized.
Exact Sciences said that in a study involving samples from 1,100 patients, Cologuard was shown to detect 64 percent of colorectal pre-cancers and 85 percent of colorectal cancers.
The company is now preparing to enroll several thousand patients in a prospective trial to obtain approval from the US Food and Drug Administration. It expects to complete the trial in 2012.