Study Design and Progress

The NCT04541030 study, sponsored by the National Cancer Institute (NCI), is a prospective observational study combining the Genomic Prostate Score (GPS) and multiparametric magnetic resonance imaging (mpMRI) to identify patients suitable for localized therapy. The target enrollment is 241 participants, and the study is being conducted at the University of Alabama at Birmingham and the NCI Clinical Center. As of the update on April 24, 2026, the status is active but not recruiting, with a final completion date expected on July 1, 2027. Since it is not an interventional clinical trial involving drug administration, it is not classified under Phase 1, 2, or 3. The primary endpoint is the ability of GPS and MRI to identify hidden high-risk disease before surgery.

Clinical Role of GPS

The commercial test Oncotype DX Genomic Prostate Score by MDxHealth SA (MDXH) is a 17-gene assay that quantifies RNA from prostate biopsy tissue. It analyzes 12 cancer-related genes associated with cellular organization, stromal response, androgen signaling, and proliferation, along with 5 reference genes, to score the risk of adverse pathology and progression in localized prostate cancer. This is a prognostic test evaluating multi-gene expression in tumors, not a companion diagnostic targeting specific drugs or single molecular targets. It is already a clinical laboratory-developed test (LDT) available for sale. It has not received FDA pre-approval or gone through an advisory committee (AdComm) process, and in the U.S., it is offered under CLIA-based testing and the FDA’s LDT enforcement discretion framework.

Clinical and Competitive Implications

Localized therapy treats only the tumor area rather than the entire prostate, reducing the burden of incontinence and sexual dysfunction. However, missing high-grade lesions outside the MRI may increase recurrence risk. Therefore, whether GPS provides additional predictive value beyond mpMRI and clinical-pathological variables will be critical for real-world adoption. Competing tests include Veracyte (VCYT)'s Decipher Prostate Genomic Classifier and Myriad Genetics (MYGN)'s Prolaris. Standard decision-making tools include PSA, Gleason grade group, staging, MRI-targeted biopsy, and active surveillance. ASCO recommends the selective use of these molecular tests when results can change treatment decisions, so this study aims to reinforce the clinical utility evidence needed for broader adoption.

Market and Transaction Structure

The global prostate cancer diagnostics market is projected to grow from $860 million in 2023 to $1.316 billion by 2030, with an estimated annual growth rate of 6.4%. MDxHealth acquired the GPS business from Genomic Health, a subsidiary of Exact Sciences Corporation (EXAS), on August 2, 2022, to build its urology precision diagnostics portfolio alongside Confirm mdx and Select mdx. The initial payment was $25 million in cash and $50 million in MDxHealth ADS, with a conditional milestone payment of up to $70 million tied to sales. After a 2023 contract revision, the milestone payment cap was increased to $82.5 million, and the initial payment was delayed until 2027, making the current maximum nominal transaction value $112.5 million.