MiraDx Announces the Commercial Availability of PROSTOX™ ultra for Prediction of Risk of Late Genitourinary Toxicity in Prostate Cancer Patients Considering Radiation Therapy

FOR IMMEDIATE RELEASE

LOS ANGELES, CA – October 1, 2025 — MiraDx, a molecular diagnostics company focused on genetic testing to personalize cancer treatment, announced today that its PROSTOX ultra test is now available for ordering in the United States. The test, which helps identify localized prostate cancer patients at increased risk of developing side effects from stereotactic body radiation therapy (SBRT), has already helped over 3,500 patients as part of an Early Access Program involving select academic centers and private practices.

PROSTOX ultra is a clinically validated genetic test that identifies patients with localized prostate cancer at higher risk of developing late genitourinary toxicity—urinary side effects such as urgency, leakage, or discomfort that may occur after treatment—with SBRT. SBRT delivers high doses of radiation over a short period of time, typically within 5-7 treatments. While SBRT is effective for treatment of prostate cancer, a subset of patients experience these side effects that present months or even years after treatment and can persist. By identifying patients with increased sensitivity to SBRT, PROSTOX ultra helps doctors and patients make more informed treatment decisions and consider alternative options when needed.

“Initial data from the PROSTOX Early Access Program in patients identified as having a high risk of toxicity to SBRT found that results from the test changed the course of treatment for 77% of these patients, helping them avoid potential complications from SBRT,” said Melissa Stoppler, MD, Executive Vice President of Medical Affairs at MiraDx. “Extending access to this test to a broader range of clinicians and clinical settings will enable more prostate cancer patients to benefit from testing for these novel biomarkers of toxicity to radiation treatments.”

PROSTOX ultra is a new and innovative test, and as such, coverage may vary depending on insurance plans. To ensure access, MiraDx is offering a Financial Assistance Program for patients, which provides reduced pricing based on household income.

To learn more about PROSTOX, visit https://miradx.com/prostox.

About MiraDx
MiraDx is a molecular diagnostics company that specializes in developing tests that support individualized cancer treatment. By analyzing an individual’s unique microRNA-based germline signatures, MiraDx enables clinicians and their patients to optimize therapeutic decision choices across radiation therapy, chemotherapy, and immunotherapy. Its tests offer a first-of-their-kind ability to predict treatment-related outcomes based on the patient, facilitating more informative, personalized cancer care.

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