MDxHealth said it will continue the scientific collaboration between NovioGendix and the Radboud University Medical Center in Nijmegen, the Netherlands, where the PCA3 test was discovered. In addition to SelectMDx, NovioGendix has a range of diagnostic tests for prostate, bladder, kidney and other urologic cancers in various stages of development.
MDx Health plans to acquire NovioGendix for up to $8.8 million, the companies said today, in a deal that expands the buyer’s uro-oncology offerings with a non-invasive urine-based molecular biomarker test for prostate cancer that is set to be launched to market next year in the U.S. and Europe.
Privately-held NovioGendix has focused on developing the “liquid biopsy,” an mRNA-based test designed to help differentiate patients with aggressive, clinically significant prostate cancer, from those with slower growing cancer. According to the company, initial comparative studies have shown the new mRNA test outperforms the prostate cancer antigen 3 (PCA3) gene test in clinical performance.
MDx Health CEO Jan Groen, Ph.D., said in a statement his company plans to launch the new test as SelectMDx for Prostate CancerTM in the US next year as a laboratory developed test. The test is CE-marked and validated to run on several PCR instruments, enabling MDx Health to enter the European and broader global urology markets with a kit option, the company said.
Dr. Groen said the NovioGendix facility in the Netherlands will allow MDx Health to expand its presence in Europe and will serve as a platform to launch the SelectMDxTM IVD kit in Europe, also in 2016.
"Our focus is to build MDxHealth into a market leader in molecular diagnostics for uro-oncology,” Dr. Groen stated. “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."
NovioGendix was founded in 2007 by Jack A. Schalken, Ph.D., and Willem Melchers, Ph.D., and began operations the following year as a Radboud University Medical Center (Radboudumc) spinout company. Main shareholders of NovioGendix include fund manager BioGeneration Ventures, and Participatiemaatschappij Oost Nederland, a regional venture capital company that is part of East Netherlands Development Agency.
MDx Health said it will propose appointing Dr. Schalken to its board as an independent director following the completion of the deal, which is expected to occur on or about September 18.
MDxHealth agreed to purchase all outstanding shares of NovioGendix Holding for up to $8.8 million in cash and stock. Of the purchase price, $5.1 million is payable in new MDxHealth shares, $283,345 in cash—and up to an additional $3.3 million cash is tied to achieving unspecified milestones. MDxHealth also agreed to grant NovioGendix a bridge loan of $680,000 to repay outstanding debts.
MDxHealth said it anticipates the acquisition will add approximately $0.5 million in 2015 operating expenses, excluding acquisition-related expenses.