MDxHealth recently signed an agreement that gives it the worldwide licensing rights to manufacture and market its prostate cancer prognostic test that uses Philips‘ recently validated biomarker PDE4D7.
MDxHealth will start preparing for the launch of its InformMDx prognostic test, which will help evaluate a patient’s risk of disease worsening and development of secondary tumors.
“This is an exciting deal, which moves us a step closer towards launching InformMDx, our fourth commercial test which we believe will be valuable in providing physicians with critical information required to make informed therapeutic decisions for men recently diagnosed with prostate cancer,” Jan Groen, CEO of MDxHealth, said in a press release.
“In line with our growth strategy, MDxHealth will continue to expand the range and reach of our diagnostic offering as the demand for actionable and cost-effective diagnosis and patient-monitoring grows across healthcare systems globally,” Groen added.
PDE4D7 was recently validated as a prognostic tool for prostate cancer in a 503 patient study published in the journal European Urology Focus.
The title of the study is “Validation of Cyclic Adenosine Monophosphate Phosphodiesterase-4D7 for its Independent Contribution to Risk Stratification in a Prostate Cancer Patient Cohort with Longitudinal Biological Outcomes.”
Researchers in the study examined the prognostic ability of PDE4D7. To do that, they assessed the levels of PDE4D7 in a patient’s tumor and determined their long-term outcomes after surgery.
Results confirmed the independent prognostic and incremental value of PDE4D7, with the levels of the biomarker correlating with prostate cancer outcomes after primary treatment.
The approach allowed doctors to improve the detection of patients with a very high risk of rapid disease relapse after surgery. Also, patients could be stratified as having low, intermediate, to high-risk clinical characteristics using this test.
InformMDx is anticipated to provide information to help guide post-biopsy treatment decisions at the time of diagnosis, as well as post-surgical treatment decisions following prostatectomy.
The American Cancer Society estimates that approximately 165,000 new cases of prostate cancer will be reported in the U.S. in 2018. In the United States alone, more than 150,000 patients annually could benefit from the InformMDx test, MDxHealth estimates.