The Belgium-based company says its ConfirmMDx test reaffirmed researchers' hopes that its test could produce a more personalized--and accurate--prostate cancer diagnosis when an initial biopsy comes back negative. About 650,000 American men each year experience prostate biopsies that come back negative, even though an estimated 25% of them may still have cancer, MDxHealth estimates.
Essentially, the results reaffirmed the usefulness of using "field effect" biomarkers GSTP1, APC, and/or RASSF1 gene promoter methylation to detect cancer next to histologically negative biopsies. Also reaffirmed: The ability to determine whether those tumors could be the result of occult aggressive prostate cancer. They found the markers in patients with otherwise benign biopsies who faced a 7 Gleason Score, versus a low volume Gleason Score of 6. Gleason scores are based on biopsies and traditionally used to stage prostate cancers.
MDxHealth said data for ConfirmMDx shows the development-stage diagnostic can be used for men who should not have a repeat biopsy after a negative initial result. The trial, the company touted, proved that the test along with a biopsy helped boost sensitivity to 74% and negative predictive value to 91%. The test is designed to identify an epigenetic field, or "halo" effect at the DNA level, spotting a tumor that would otherwise be missed by the gold-standard biopsy and scrutiny under a microscope. By relying on an existing biopsy, it will hopefully help rule out the need for repeat biopsies and then reel in patients at high risk of the cancer for whom a a repeat biopsy and treatment could actually help, the company explains.
While more testing is in the mix, the results are encouraging enough to plow forward with more trials. And the company is already planning for the future, having raised $12.6 million in private equity in July to help scale up its U.S. sales efforts.
MDxHealth detailed its clinical trial results at the ASCO Genitourinary Cancers Symposium 2013, from Feb. 14-16, 2013 in Orlando, FLA.
- read the release
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