Tuesday, September 15, 2015
MDxHealth SA, announced that it has entered into an agreement to acquire NovioGendix, a privately-held molecular diagnostics company focused on the development of a non-invasive liquid biopsy test for prostate cancer.
Each year, 1.8 million prostate biopsy procedures are performed in the U.S. and the EU. However, the results for 1.3 million of these men will be negative, meaning that a significant proportion could have avoided a biopsy, itself a painful and invasive procedure with serious potential side effects. More accurate non-invasive tests could help prostate cancer-free men safely avoid unnecessary biopsies, while helping to identify men who may be harboring aggressive prostate cancer, who will benefit from earlier detection.
NovioGendix's proprietary urine-based, molecular biomarker test for prostate cancer offers a non-invasive "liquid biopsy" method to identify patients at low risk for prostate cancer, thereby aiding in the reduction of unnecessary prostate biopsy procedures and concomitant complications and expense. This mRNA biomarker test can also help identify men at increased risk of high-grade disease who may benefit most from a prostate biopsy procedure. NovioGendix's test is CE-marked, and has been validated to run on several PCR instruments, opening the opportunity for the sale of reagent kits.
Dr. Jan Groen, Chief Executive Officer of MDxHealth, commented: "Our focus is to build MDxHealth into a market leader in molecular diagnostics for uro-oncology. The acquisition of NovioGendix provides us with a validated, non-invasive, actionable testing option for prostate cancer and allows us to address the larger market opportunity of initial prostate biopsy for early cancer detection, complementing our ConfirmMDx test for repeat biopsy."
"We plan to launch this new non-invasive urine test as SelectMDx for Prostate CancerTM on the US market in 2016 as a laboratory developed test. The test is CE-marked enabling us to enter the European and broader global urology markets with a kit option. The NovioGendix facility in the Netherlands allows us to expand our presence in Europe and will serve as a platform to launch the SelectMDxTM IVD kit on the European market in 2016."
MDxHealth will continue the scientific collaboration established between NovioGendix and the Radboud University Medical Center in Nijmegen, The Netherlands. Since its founding in 2007, co-founders Dr. Jack A. Schalken and Dr. Willem Melchers and the NovioGendix team have capitalized on the experience gained in the development and commercialization of the PCA3 gene test for prostate cancer, a urine test which was discovered at the Department of Urology at Radboud University Medical Center, but has several drawbacks.
NovioGendix recognized the recent shift in clinical management of prostate cancer and set about developing a test that could help differentiate patients with aggressive, clinically significant prostate cancer, from those with slower growing cancer, which was one of the shortcomings of the PCA3 test. Initial comparative studies have shown the new mRNA test outperforms the PCA3 test in clinical performance.
Dr. Willem Melchers, Chief Executive Officer of NovioGendix, commented: "MDxHealth is the optimum strategic fit to ensure that NovioGendix's unique, non-invasive prostate cancer test is successfully commercialized internationally. We are very excited to be working with the MDxHealth team to continue our commitment to delivering high quality molecular tests that improve the medical care of urological cancer patients around the world."
mdxhealth.com
