MDxHealth (NASDAQ:MDXH) NV is a molecular diagnostics company specializing in the development and commercialization of genomic-based tests for urologic cancers. Founded in 2004 and headquartered in Liège, Belgium, with a North American hub in Irvine, California, MDxHealth leverages advanced epigenetic and transcriptomic technologies to improve diagnostic accuracy and patient management. The company’s assays aim to address unmet clinical needs in prostate and bladder cancer by reducing unnecessary biopsies and guiding treatment decisions.
MDxHealth’s flagship product, SelectMDx, is a non-invasive urine-based test designed to assess the risk of clinically significant prostate cancer, helping physicians decide whether a biopsy is warranted. ConfirmMDx, a tissue-based epigenetic assay, identifies DNA methylation changes in prostate tissue to detect patients at risk of harboring aggressive disease missed by initial biopsy. In addition, the firm is advancing its next-generation blood-based IsoPSA test, which employs proprietary signal processing algorithms to distinguish benign from malignant prostate conditions and refine patient selection for further workup.
The company’s commercial footprint spans the United States, Europe and select markets in Asia Pacific. In North America, MDxHealth collaborates with leading urology practices, reference laboratories and payers to facilitate test adoption and reimbursement. Its European operations support clinical validation studies and market access initiatives across key territories, while strategic partnerships in Asia Pacific drive local engagement and regulatory approvals. MDxHealth continues to invest in real-world evidence generation and health economics research to demonstrate the clinical utility and cost-effectiveness of its assays.
Under the leadership of CEO James Voelkel and a seasoned executive team, MDxHealth remains committed to advancing precision diagnostics in urologic oncology. The company’s board of directors includes experts in molecular biology, diagnostics commercialization and health care policy, providing strategic guidance as MDxHealth expands its product portfolio and geographic reach. With multiple late-stage programs in development, MDxHealth seeks to strengthen its role as a partner to clinicians and patients in the global fight against cancer.
