PROSTOX ultra identifies patients at higher risk of developing late genitourinary toxicity from stereotactic body radiation therapy.
MiraDx has announced the commercial availability of PROSTOX ultra, a genetic test designed to predict the risk of late genitourinary toxicity in prostate cancer patients considering stereotactic body radiation therapy (SBRT).
The test identifies patients with localized prostate cancer who are at higher risk of developing urinary side effects such as urgency, leakage, or discomfort that may occur months or years after SBRT treatment. More than 3,500 patients have already used the test through an Early Access Program involving select academic centers and private practices.
SBRT delivers high doses of radiation over a short period, typically within five to seven treatments. While effective for treating prostate cancer, a subset of patients experience persistent side effects that can present long after treatment completion.
“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,” says Melissa Stoppler, MD, executive vice president of medical affairs at MiraDx, in a release.
Test Methodology and Clinical Impact
PROSTOX ultra is a clinically validated genetic test that analyzes microRNA-based germline signatures to identify patients with increased sensitivity to SBRT. By providing this information before treatment begins, the test helps physicians and patients make more informed treatment decisions and consider alternative options when appropriate.
The test represents part of MiraDx’s broader approach to personalizing cancer treatment through molecular diagnostics. The company specializes in developing tests that analyze individual microRNA-based germline signatures to optimize therapeutic decisions across radiation therapy, chemotherapy, and immunotherapy.
Availability and Coverage
The test is now broadly available to US clinicians for patients with localized prostate cancer considering SBRT. As a novel diagnostic tool, insurance coverage may vary depending on individual plans.
To ensure patient access, MiraDx is offering a Financial Assistance Program that provides reduced pricing based on household income for eligible patients.
“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,” says Stoppler in a release.
Photo caption: MiraDX lab
Photo credit: MiraDX
