Mdxhealth and University of Oxford to validate GPS test in largest randomized trial of treatment effectiveness in patients with localized prostate cancer
Rhea-AI Summary
mdxhealth (NASDAQ: MDXH) announced initiation of Genomic Prostate Score (GPS) testing in the UK ProtecT randomized trial to validate GPS in an Active Surveillance cohort.
The ProtecT trial followed >1,500 men with localized prostate cancer for over two decades across Active Surveillance, Radical Prostatectomy, and Radiotherapy, providing long-term outcomes that the GPS-ProtecT study will leverage to test GPS's predictive power.
This follows a prior ProMPT validation and aims to generate randomized clinical-trial evidence supporting GPS's clinical utility and potential influence on guidelines, payer coverage, and provider adoption.
Positive
- Access to a >1,500-patient ProtecT randomized trial sample set
- ProtecT includes >20 years of clinical follow-up across AS, RP, and RT
- Builds on completed ProMPT validation of GPS
Negative
- Study is an initiation with no immediate clinical or commercial readout
- Validation timeline may be lengthy given ProtecT's multi-decade follow-up
News Market Reaction – MDXH
In the Jan 6 session, MDXH declined 3.02%, reflecting a moderate negative market reaction. Our momentum scanner triggered 2 alerts that day, indicating moderate trading interest and price volatility.
Data tracked by StockTitan Argus on the day of publication.
Key Figures
Historical Context
| Date | Event | Sentiment | 24h Move | Catalyst |
|---|---|---|---|---|
| Nov 12 | Q3 2025 earnings | Positive | -7.4% | Revenue growth, better margins, smaller net loss, added Exosome business. |
| Nov 03 | Earnings preview | Neutral | -1.6% | Announcement of Q3 2025 release date and conference call logistics. |
| Sep 15 | Exosome acquisition close | Positive | +3.8% | Closed $15M ExoDx deal, adding prostate test and CLIA lab assets. |
| Aug 05 | Q2 results & deal | Positive | +10.4% | Strong Q2 growth, positive adjusted EBITDA, and ExoDx acquisition announcement. |
24h Move is the share-price change in the day after each event; other market factors may also have contributed.
Recent history shows mixed reactions: strategic acquisitions and strong quarterly reports sometimes drew positive moves, while earnings releases also triggered notable sell-offs.
Over the past months, mdxhealth reported rising revenues and improving profitability, with Q2 and Q3 2025 delivering $26.6M and $27.4M in revenue and positive adjusted EBITDA. The company closed the $15M Exosome Diagnostics acquisition, adding the ExoDx prostate test and a CLIA lab. Despite these milestones, shares fell -7.42% after Q3 earnings and -1.63% around the Q3 results date, while the August earnings and acquisition update saw a 10.44% gain, underscoring inconsistent news reactions.
Key Terms
genomic prostate score medical
active surveillance medical
randomized clinical trial medical
radical prostatectomy medical
radiotherapy medical
AI-generated analysis. How Rhea-AI works. Not financial advice.
Mdxhealth and University of Oxford to validate GPS test in largest randomized trial of treatment effectiveness in patients with localized prostate cancer
IRVINE, CA – January XX, 2026 (GlobeNewswire) – Mdxhealth SA (NASDAQ: MDXH) (the “Company” or “mdxhealth”), a leading precision diagnostics company, today announced the next major phase of its collaboration with the University of Oxford: the initiation of Genomic Prostate Score (GPS) testing in the landmark UK ProtecT trial (Prostate Testing for Cancer and Treatment). This study is designed to establish GPS as the first genomic classifier supported by randomized clinical trial evidence in an Active Surveillance cohort, further validating the clinical utility of GPS in predicting prostate cancer progression and long-term treatment outcomes.
Michael K. McGarrity, Chief Executive Officer of mdxhealth, commented: “This is a transformative moment for prostate cancer precision diagnostics – no other patient cohort combines this level of rigor, long-term follow-up, and potential impact on clinical practice guidelines, payer coverage and provider adoption for patients diagnosed with localized prostate cancer.”
The ProtecT Trial
The UK ProtecT (Prostate Testing for Cancer and Treatment) trial is widely regarded as the world’s largest randomized clinical trial of treatment effectiveness in localized prostate cancer. Following more than 1,500 men with localized disease for over two decades, the study provides unmatched long-term clinical outcome data across AS/AM, Radical Prostatectomy (RP), and Radiotherapy (RT).
Professor Hamdy, University of Oxford, commented: “The ProtecT trial has contributed to shaping international standards for prostate cancer management. By incorporating the Genomic Prostate Score (GPS) test, we are building on decades of outcomes data with genomic insights that could redefine how physicians evaluate risk and personalize care for patients worldwide.”
This study builds on the partnership announced in September 2023, in which mdxhealth and Oxford began evaluating the correlation between GPS and prostate cancer progression using samples from the well-annotated ProMPT cohort. With the ProMPT validation successfully completed, the initiation of the GPS-ProtecT study will now leverage one of the most definitive, long-term prostate cancer sample- and data-sets in the world to demonstrate the predictive power of GPS in the context of a mature prospective, randomized trial.
About Mdxhealth
Mdxhealth is a leading precision diagnostics company that provides actionable molecular information to personalize patient diagnosis and treatment. The Company’s tests are based on proprietary genomic, epigenetic (methylation), exosomal and other molecular technologies and assist physicians with the diagnosis and prognosis of prostate cancer and other urologic diseases. The Company’s U.S. headquarters and laboratory operations are in Irvine, California, with additional laboratory operations in Waltham, Massachusetts and Plano, Texas. European headquarters are in Herstal, Belgium. For more information, visit mdxhealth.com and follow us on social media at: twitter.com/mdxhealth, facebook.com/mdxhealth and linkedin.com/company/mdxhealth.
Forward-Looking Statement: This press release contains forward-looking statements and estimates with respect to the anticipated future performance of MDxHealth and the market in which it operates, all of which involve certain risks and uncertainties. These statements are often, but are not always, made through the use of words or phrases such as “potential,” “expect,” “will,” “goal,” “next,” “potential,” “aim,” “explore,” “forward,” “future,” and “believes” as well as similar expressions. Forward-looking statements contained in this release include, but are not limited to, statements regarding expected future product development and performance results; our strategies, positioning, resources, capabilities and expectations for future events or performance; and the anticipated timing and benefits of our acquisitions, including estimated synergies and other financial impacts. Such statements and estimates are based on assumptions and assessments of known and unknown risks, uncertainties and other factors, which were deemed reasonable but may not prove to be correct. Actual events are difficult to predict, may depend upon factors that are beyond the company’s control, and may turn out to be materially different. Examples of forward-looking statements include, among others, statements we make regarding expected future operating results, product development efforts, our strategies, positioning, resources, capabilities and expectations for future events or performance. Important factors that could cause actual results, conditions and events to differ materially from those indicated in the forward-looking statements include, among others, the following: our ability to successfully and profitably market our products; the acceptance of our products and services by healthcare providers; our ability to achieve and maintain adequate levels of coverage or reimbursement for our current and future solutions we commercialize or may seek to commercialize; the willingness of health insurance companies and other payers to cover our products and services and adequately reimburse us for such products and services; our ability to obtain and maintain regulatory approvals and comply with applicable regulations; timing, progress and results of our research and development programs; the period over which we estimate our existing cash will be sufficient to fund our future operating expenses and capital expenditure requirements; our ability to remain in compliance with financial covenants made to and make scheduled payments to our creditors; the possibility that the anticipated benefits from our business acquisitions like our acquisition of the ExoDx business and GPS prostate cancer business will not be realized in full or at all or may take longer to realize than expected; and the amount and nature of competition for our products and services. Other important risks and uncertainties are described in the Risk Factors sections of our most recent Annual Report on Form 20-F and in our other reports filed with the Securities and Exchange Commission. MDxHealth expressly disclaims any obligation to update any such forward-looking statements in this release to reflect any change in its expectations with regard thereto or any change in events, conditions or circumstances on which any such statement is based unless required by law or regulation. This press release does not constitute an offer or invitation for the sale or purchase of securities or assets of MDxHealth in any jurisdiction. No securities of MDxHealth may be offered or sold within the United States without registration under the U.S. Securities Act of 1933, as amended, or in compliance with an exemption therefrom, and in accordance with any applicable U.S. securities laws.
NOTE: The mdxhealth logo, mdxhealth, Confirm mdx, Select mdx, Resolve mdx, Genomic Prostate Score, Exosome Diagnostics, ExosomeDx, ExoDx, ExoDx Prostate Intelliscore (EPI), and Monitor mdx are trademarks or registered trademarks of MDxHealth SA and its affiliates. The GPS test was formerly known as and is frequently referenced in guidelines, coverage policies, reimbursement decisions, manuscripts and other literature as Oncotype DX Prostate, Oncotype DX GPS, Oncotype DX Genomic Prostate Score, and Oncotype Dx Prostate Cancer Assay, among others. The Oncotype DX trademark, the Bio-Techne trademark, and all other trademarks and service marks, are the property of their respective owners.
For more information:
info@mdxhealth.com
LifeSci Advisors (IR & PR)
John Fraunces
Managing Director
Tel: +1 917 355 2395
Jfraunces@lifesciadvisors.com
ir@mdxhealth.com
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