MDxHealth announced that it will begin Genomic Prostate Score (GPS) testing in the UK ProtecT trial, the world’s largest randomized study of treatment effectiveness for localized prostate cancer. The partnership with the University of Oxford will allow GPS to be evaluated in a cohort of more than 1,500 men followed for over two decades, providing robust long‑term outcome data on active surveillance, radical prostatectomy, and radiotherapy.
GPS is a 17‑gene genomic assay that stratifies risk in men with localized prostate cancer. By integrating GPS into the ProtecT trial, MDxHealth aims to demonstrate the test’s predictive power for disease progression and treatment outcomes in a rigorously controlled setting. The data generated could support stronger payer coverage decisions, influence clinical guidelines, and accelerate adoption of GPS among urologists and pathologists worldwide.
MDxHealth’s strategy is to build a comprehensive, evidence‑backed diagnostic pathway for prostate cancer. Successful validation in ProtecT would reinforce GPS’s clinical utility, potentially expanding its market share and solidifying the company’s position as a leader in precision urology diagnostics. The company has recently reported strong financial performance, with Q1 2025 revenue up 22% year‑over‑year to $24.3 million and an adjusted EBITDA improvement of 71%. MDxHealth reiterated its 2025 revenue guidance of $108–$110 million and expects adjusted EBITDA profitability in Q2 2025.
CEO Michael K. McGarrity described the ProtecT collaboration as a “transformative moment for prostate cancer precision diagnostics,” emphasizing the trial’s rigorous design and long‑term follow‑up. Professor Hamdy of the University of Oxford highlighted that incorporating GPS could “redefine how physicians evaluate risk and personalize care for patients worldwide.”
The prostate cancer diagnostics market is valued at approximately $2.3 billion, with potential to grow to $4.8 billion. The ProtecT trial’s large, randomized design and extended follow‑up period are expected to provide high‑impact evidence that could shape clinical practice and payer decisions, positioning MDxHealth to capture a significant share of this expanding market.
The launch of GPS testing in the ProtecT trial marks a significant milestone for MDxHealth, positioning the company to deliver compelling evidence that could influence treatment guidelines, payer coverage, and clinical adoption of precision diagnostics for prostate cancer.
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