Prostate cancer test meets primary endpoints in trial

October 14, 2013

MDxHealth SA said its ConfirmMDx for Prostate Cancer test met all of the primary endpoints in a recently completed clinical validation trial.

MDxHealth SA said its ConfirmMDx for Prostate Cancer test met all of the primary endpoints in a recently completed clinical validation trial.

In related news, MDxHealth has signed agreements with a number of health insurance providers, providing expanded access to the test.

Preliminary analysis of data from the multicenter, blinded DOCUMENT (Detection of Cancer Using Methylated Events in Negative Tissue) trial verifies the epigenetic test’s high negative predictive value for ruling out the presence of prostate cancer, according to the company, and is a significant, independent predictor of risk for men being considered for repeat biopsy.

“This validation study confirms the high negative predictive value of the ConfirmMDx test in a U.S. population,” said Wim van Criekinge, PhD, of the University of Ghent in Belgium and chief scientific officer for MDxHealth. “The clinical utility of this test lies in its ability to reduce unnecessary repeat biopsies, improving patient care and optimizing limited health care resources.”

ConfirmMDx for Prostate Cancer is performed on the residual prostate tissues from the previous negative biopsy, providing epigenetic information beyond histopathology alone to enable more informed patient management decisions. The DOCUMENT study, conducted at five major U.S. urologic centers, involved analyzing tissue from initial negative biopsies and comparing assay results to cancer detection in subsequent biopsies within 24 months.

ConfirmMDx for Prostate Cancer was used to analyze the epigenetic profile of prostate biopsy cores from 350 men screened by PSA. The study’s findings are consistent with the results from an earlier European clinical validation study that demonstrated a negative predictive value of 90% (95% CI: 86%-94%), MDxHealth said.

Results from the DOCUMENT study will be published after full analysis of the data is completed.

Separately, the company said it has signed insurance contracts that extend access to the prostate cancer test to more than 60 million covered lives. The agreements are with health insurance providers FedMed, Inc., America's Choice Provider Network, Inc. (ACPN), and Stratose.

FedMed and ACPN members consist of insurance carriers, third-party administrators, health and welfare funds, and self-insured health plans. Stratose (formerly operating as Coalition America, NPPN, OPPN, PlanCare America, 4MOST Health, Qualident and KeyClaims) maintains a large directly managed PPO network, including more than 850,000 direct and affiliate medical, dental, and workers' compensation provider contracts.

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