MiraDx Launches New PROSTOX Genetic Test for Prostate Cancer Patients

Why It Matters

The test gives physicians a biology‑driven tool to avoid severe urinary side effects, potentially reducing downstream healthcare costs and enhancing patient confidence in treatment decisions.

Key Takeaways

• PROSTOX Standard predicts GU toxicity for CFRT/MHFRT
• Test uses cheek swab, results in 5‑7 days
• More than 20% experience persistent urinary side effects
• PROSTOX Ultra assesses risk for SBRT, complementing Standard
• Genetic variants in microRNAs drive individual radiation tolerance

Pulse Analysis

Localized prostate cancer is treated primarily with external‑beam radiation therapy, including conventionally fractionated, moderately hypofractionated, and stereotactic body radiation regimens. While cure rates exceed 99% at five years, more than one‑fifth of patients develop late genitourinary toxicity that can impair quality of life for years after treatment. Historically, clinicians have relied on tumor staging and patient comorbidities to choose a regimen, lacking a biology‑driven tool to anticipate side‑effect risk. MiraDx’s launch of PROSTOX Standard fills this gap by offering a genetic risk assessment specifically for conventional and moderately hypofractionated radiation.

The PROSTOX platform analyzes inherited variants in microRNA pathways that modulate DNA repair and inflammatory responses to ionizing radiation. A simple cheek swab provides sufficient DNA, and the assay delivers actionable results within five to seven days. Clinical validation demonstrates that the test reliably stratifies patients into high‑ and low‑risk groups for late urinary toxicity, enabling physicians to match the most tolerable radiation modality—whether conventional, hypofractionated, or stereotactic. By integrating genetic insight into treatment planning, PROSTOX empowers shared decision‑making and may reduce the incidence of chronic urinary symptoms.

From a business perspective, the addition of PROSTOX Standard expands MiraDx’s addressable market beyond the niche SBRT segment served by PROSTOX Ultra, potentially reaching the majority of prostate cancer patients undergoing radiation. Early adoption could translate into lower downstream costs for health systems by preventing expensive interventions for severe GU toxicity. Moreover, the test aligns with the broader shift toward precision oncology, where payers increasingly reward biomarker‑guided therapies. As more oncologists incorporate genetic toxicity profiling, MiraDx is positioned to become a standard‑of‑care partner in radiation oncology, driving revenue growth and reinforcing its leadership in molecular diagnostics.