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Exact Sciences to Use MDxHealth Methylation Biomarker, PCR Tech in Cologuard Test


MDxHealth said this week that Exact Sciences will use MDxHealth's methylation biomarker and methylation-specific PCR technology in Cologuard, Exact's non-invasive, stool-based DNA colon cancer screening test currently under development.

Exact Sciences licensed several methylation biomarkers, among other biomarkers, and the PCR technology in July, before MDxHealth changed its name from OncoMethylome. Exact has been evaluating the technologies since that time, in studies with Cologuard.

The confirmation that Exact will use MDxHealth's technology triggers an undisclosed milestone payment to MDxHealth, which will also receive royalties on net sales once the test is commercialized.

Exact Sciences said that in a recently completed 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.

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