New Prostate Cancer Test Promises Major Cost Savings, Better Outcomes

LOS ANGELES, CA – December 18, 2025 – A new genetic test for men with localized prostate cancer is poised to significantly alter treatment paradigms, promising not only to improve patient quality of life by preventing debilitating side effects but also to deliver substantial long-term savings to the healthcare system. The test, known as PROSTOX™ ultra, was the subject of a new economic analysis published in the peer-reviewed Journal of Health Economics and Outcomes Research, which quantifies its dual benefits in unprecedented detail.

Developed by molecular diagnostics company MiraDx, PROSTOX™ ultra is a germline genetic test designed to identify patients who have a higher-than-average risk of developing severe urinary side effects from stereotactic body radiation therapy (SBRT). While SBRT is an effective and convenient treatment option—often completed in just five to seven sessions—a subset of men experience persistent and life-altering genitourinary (GU) toxicity, including urinary urgency, leakage, or pain, which can emerge months or even years after treatment.

The new study provides compelling evidence that by identifying these at-risk individuals beforehand, physicians and patients can make more informed decisions, often opting for alternative treatments and thereby avoiding complications that are both physically taxing for the patient and costly for the healthcare system to manage.

The Economic Case for Personalized Radiation Therapy

The financial implications detailed in the JHEOR publication are striking. The study, an economic evaluation that modeled the clinical pathways for prostate cancer patients, found that integrating the PROSTOX™ ultra test into the decision-making process could save the healthcare system an estimated $19,615 per patient tested in the short term.

Over a patient's lifetime, these savings are projected to grow to approximately $24,777. These figures account for the costs avoided in managing chronic GU toxicity, which can involve expensive medications, invasive procedures, and frequent physician visits over many years. Beyond the direct financial savings, the analysis also quantified the improvement in patient well-being, finding that each patient tested with PROSTOX™ ultra is expected to gain an average of 0.24 quality-adjusted life years (QALYs). This metric is a cornerstone of health economics, representing not just a longer life, but a life lived with better health and less suffering.

“Physicians in practice using PROSTOX ultra are seeing its benefits in helping their patients avoid late GU toxicity from SBRT. These new results also now show that PROSTOX ultra meaningfully reduces the long-term cost burden on the healthcare system,” said Dr. Melissa Stoppler, Executive Vice President of Medical Affairs at MiraDx, in a statement accompanying the announcement. “This new evidence further validates the value of integrating the test into treatment considerations for localized prostate cancer.”

The findings position the test as a key tool in the growing movement toward value-based care, where the focus is on achieving better patient outcomes at a lower overall cost. For insurers and healthcare administrators grappling with ever-rising expenditures, diagnostic tools that can preemptively identify risk and guide more effective resource allocation are becoming increasingly critical.

Empowering Patients and Improving Quality of Life

While the economic data is compelling for payers and policymakers, the most immediate impact of PROSTOX™ ultra is felt by the patients themselves. For men diagnosed with localized prostate cancer, the choice of treatment involves a complex balance between eradicating the cancer and preserving long-term quality of life. The threat of permanent side effects like incontinence or chronic urinary discomfort can be a significant source of anxiety.

The test provides a personalized risk assessment, empowering patients and their doctors with crucial information to navigate this decision. Data from an Early Access Program, which involved over 3,500 patients before the test's full commercial launch on October 1, 2025, showed that the results had a tangible impact on care. For patients identified by the test as being at high risk for SBRT toxicity, a remarkable 77% altered their treatment plan.

Instead of proceeding with SBRT, these patients and their physicians often chose alternative radiation regimens, such as moderately hypofractionated radiotherapy (MHFRT) or conventionally fractionated radiotherapy (CFRT). These treatments, delivered over a longer period, have been shown to be safer for this specific high-risk group, leading to substantially lower rates of late GU toxicity. This shift in treatment demonstrates the test's clinical utility in real-world settings, directly translating a genetic data point into a decision that protects patient well-being. This aligns perfectly with the core missions of patient advocacy organizations, which have long championed shared decision-making and a greater focus on survivorship and quality of life after cancer treatment.

The Science of Prediction: Decoding MicroRNA Signatures

What sets PROSTOX™ ultra apart from other diagnostic tools in the prostate cancer space is its underlying technology. Unlike prognostic tests such as Oncotype DX or Prolaris, which analyze tumor tissue to gauge a cancer's aggressiveness, PROSTOX™ ultra analyzes a patient's own inherited genetics—their germline DNA—from a simple blood or saliva sample.

Specifically, the test focuses on microRNA single-nucleotide polymorphisms (mirSNPs), which are subtle variations in regions of DNA that regulate gene expression. MiraDx's research has identified specific mirSNPs that are associated with an individual's inflammatory response to radiation. By analyzing these genetic markers, the test can predict how a patient's healthy tissues will react to the high-dose radiation delivered during SBRT.

The scientific validity of this approach has been reinforced by independent research. A study published in Clinical Cancer Research, based on the phase 3 MIRAGE trial, confirmed the test's predictive power. In that trial, PROSTOX™ ultra demonstrated high accuracy, with a negative predictive value of 96%, meaning that patients with a low-risk result can proceed with SBRT with very high confidence that they will not develop severe late GU toxicity. While one of the lead investigators in the validation studies, Dr. Amar Kishan of UCLA, is also a co-founder of MiraDx, the research has undergone rigorous peer review and was presented at major medical conferences, including the American Society for Radiation Oncology (ASTRO) 2025 annual meeting.

This focus on predicting treatment toxicity, rather than disease prognosis, carves out a unique and complementary niche for the test in the increasingly personalized landscape of oncology.

The Road to Widespread Adoption

With its commercial launch in the U.S. in October 2025, PROSTOX™ ultra has moved from the research lab to the clinic. However, the path from innovation to standard of care involves navigating the complex realities of the healthcare system. A key hurdle for any new diagnostic is securing widespread reimbursement from both government payers like Medicare and private insurance companies.

Recognizing this potential barrier, MiraDx has established a Financial Assistance Program to make the test more accessible to patients while full coverage decisions are pending. The robust economic data from the JHEOR study is designed to make a strong case to payers that covering the test is not just a cost, but an investment that yields significant long-term savings.

The test enters a market with other advanced diagnostic tools, but its unique focus on predicting radiation toxicity from germline DNA gives it a first-mover advantage. By providing information that no other test currently offers, it helps fill a critical gap in the treatment-planning process for one of the most common cancers affecting men. As clinicians and health systems increasingly prioritize both clinical efficacy and economic value, tools like PROSTOX™ ultra that deliver on both fronts are likely to become an indispensable part of modern cancer care.