NEW YORK (GenomeWeb) – MDxHealth today announced it has signed an agreement to include its recently acquired SelectMDx prostate cancer test in a prospective clinical trial at The Netherlands' Radboud University Medical Center.
The study is looking at the effectiveness of new technologies in prostate cancer testing.
The 4M clinical study of 600 test subjects will evaluate the effectiveness of the PCR-based SelectMDx test in tandem with magnetic resonance imaging to suggest patients for prostate biopsies. SelectMDx uses two mRNA markers derived from urine samples to identify patients with a low risk of developing prostate cancer.
Financial and other details of the agreement were not disclosed.
MDxHealth gained the rights to the CE-marked test last month when it purchased Radboud University Medical Center spinout NovioGendix for $8.8 million.
"Given the recent controversy over PSA screening, and concerns about over diagnosis and treatment of prostate cancer patients, there is a well-defined need for better tools to diagnose and manage prostate cancer patients," J.O. Barentsz, principal investigator of the 4M study and a professor at Radboud University Medical Center, said in a statement. "We are eager to investigate the potential synergies of the SelectMDx test in combination with MRI. We want to know if the SelectMDx test can enhance patient selection for MRI-guided prostate biopsies, thereby optimizing resources, decreasing healthcare costs, and improving patient outcomes."
In August, MDxHealth signed an agreement with The Netherlands' Erasmus University Medical Center giving the firm exclusive worldwide rights to methylation biomarkers for bladder cancer.