PharmacoDx facility will build on existing partnership to develop new products.

Belgium-based cancer molecular diagnostics firm MDxHealth has established a new companion diagnostics division, MDxHealth PharmacoDx, in Ghent. The new facility will build on the firm’s existing bioinformatics and translational medicine partnership with Ghent University. The partners will work together to develop gene methylation-based companion diagnostics for use in drug development and alongside cancer therapy. MdXHealth’s existing Flemish subsidiary and personnel will be merged with the new MDxHealth PharmacoDx facility.

“Strengthening our collaboration with Ghent University is key for our pharmacodiagnostic development capabilities,” comments Jan Croen, Ph.D., MDxHealth CEO. “The development and commercialization of clinical and companion diagnostics are at the heart of MDxHealth’s growth strategy.”

MDxHealth is exploiting its DNA-based methylation expertise to develop and commercialize both clinical diagnostic and pharmacodiagnostic products for personalized cancer treatment and cancer drug development. Its clinical diagnostics pipeline is being developed, validated, and commercialized independently for use by physicians in the assessment of cancer diagnosis and prognosis. The pharmacodiagnostic products are being developed and validated in collaboration with pharmaceutical companies for use in the clinical trials and regulatory approval process, and to help improve treatment decisions. MDxHealth has an ISO-certified service laboratory in Liege, Belgium, and intends to offer its products in North America through a CLIA-certified service laboratory.

Prognostic and predictive MDx products are currently in development for a range of cancer types and will be commercialized through a network of clinical collaborations. A combination of different assays will be developed for each cancer type, MDxHealth points out. The ConfirmMDx products will serve as an aid for physicians to assess the presence or absence of cancer. The InformMDx tests will be designed to provide prognostic assessment to distinguish between aggressive and nonaggressive tumors. PredictMDx products will be designed to provide predictive information indicating which drug or treatment regimen is likely to be most effective for the individual patient.

ConfirmMDx and InformMDx tests for prostate, lung, and colorectal cancers are currently at the verification or validation stage. PredictMDx assays are separately in development for brain, colon, and breast/ovarian cancers. The most advanced of the PredictMDx assays, for brain cancer, is being prepared for pivotal trials, and is designed to predict a patient’s response to alkylating agents.

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