Molecular diagnostic company MDxHealth has reported that its ConfirmMDx for prostate cancer test met all primary endpoints in the recently completed multicentre, blinded 'Detection of Cancer Using Methylated Events inNegative Tissue' (DOCUMENT) clinical validation trial.
The DOCUMENT study, which was conducted at five major US urologic centres, used ConfirmMDx to analyse the epigenetic profile of prostate biopsy cores from 350 men screened by PSA.
Preliminary data has verified the test's high negative predictive value (NPV) for ruling out the presence of prostate cancer, which is considered as a significant, independent predictor of risk for men being considered for repeat biopsy.
The study analysed tissue from initial negative biopsies and compared assay results to cancer detection in subsequent biopsies within 24 months.
MDxHealth CEO Dr Jan Groen said the company is extremely pleased with these results, demonstrating that ConfirmMDx for Prostate Cancer validates as a significant, independent predictor for the presence of prostate cancer in a repeat biopsy.
"These findings are consistent with the results from our earlier European clinical validation study that demonstrated a NPV of 90%," Dr Groen said.
Results from the DOCUMENT study will be published once full analysis of the data is complete.
Performed on the residual prostate tissues from the previous negative biopsy, the non-invasive assay provides critical insights beyond histopathology to facilitate more informed patient management decisions.
ConfirmMDx detects an epigenetic field effect or 'halo' associated with the cancerisation process at the DNA level in cells adjacent to cancer foci.
This epigenetic 'halo' around a cancer lesion can be present despite having a normal appearance under the microscope.
University of Ghent professor and MDxHealth chief scientific officer Dr Wim van Criekinge said this validation study confirms the high negative predictive value of the ConfirmMDx test in a US population.
"The clinical utility of this test lies in its ability to reduce unnecessary repeat biopsies, improving patient care and optimizing limited healthcare resources," Dr Criekinge said.
The epigenetic assay, ConfirmMDx for prostate cancer, helps urologists distinguish patients who have a true-negative biopsy from those at risk from occult cancer, and rule out prostate cancer-free men from undergoing unnecessary repeat biopsies.
According to GlobalData estimates, the tumour markers market in the US was valued at $489.4m in 2012 and is expected to grow at a CAGR of 6.6% to reach $765m by 2019.