Emerging Diagnostics in Uro-Oncology: MicroRNA Assays and Their Impact

A newly published economic analysis in the Journal of Health Economics and Outcomes Research spotlights a potentially practice-changing tool in prostate cancer care.

The study focuses on PROSTOX™ ultra, a germline genetic test developed by MiraDx, which offers predictive insight into late-onset urinary toxicity following radiation therapy. Beyond its clinical precision, the test demonstrates compelling economic and quality-of-life benefits—pointing to a future where genetic data may drive not just personalized care but system-wide cost reductions.

Prostate cancer remains one of the most prevalent cancers among men, and stereotactic body radiation therapy (SBRT) is an increasingly preferred treatment due to its convenience—delivered in just 5 to 7 high-dose sessions. While effective, SBRT carries the risk of delayed genitourinary (GU) side effects, such as urinary urgency, incontinence, and discomfort, which may arise months or years after treatment and persist indefinitely.

PROSTOX ultra addresses this issue by identifying germline genetic variants associated with increased susceptibility to these late toxicities. Armed with this information, clinicians can tailor treatment plans more precisely—either proceeding with SBRT or considering alternative strategies in patients deemed high-risk.

The health economics study compared clinical pathways using PROSTOX ultra versus standard of care (which currently does not incorporate genetic risk stratification). The findings were striking: $19,615 in average cost savings per patient tested using PROSTOX ultra; $24,777 in lifetime healthcare system savings per patient; and 0.24 additional quality-adjusted life years (QALYs) per patient—indicating not just lower costs, but better patient-reported outcomes. While those figures represent per-patient impacts, the broader implications for national health systems and payers could be substantial, particularly as prostate cancer affects roughly one in eight men during their lifetime.

This alignment of clinical benefit and economic efficiency strengthens the case for integrating germline genetic testing into standard treatment planning for localized prostate cancer. In a value-based care environment, tools that reduce downstream complications while supporting shared decision-making are gaining traction.

MiraDx, the company behind PROSTOX ultra, is advancing a broader mission of personalized cancer care through germline microRNA-based diagnostics. Unlike somatic tests that focus on tumor mutations, MiraDx’s approach uses inherited genetic signatures to predict treatment-related toxicities and outcomes, particularly in radiation and immunotherapy contexts.

These tools are not designed to replace standard treatments, but to refine and optimize them—giving clinicians a new layer of data to support nuanced decisions that align with individual patient risk profiles and quality-of-life priorities.

The PROSTOX ultra model offers a glimpse of how precision diagnostics can reshape care pathways—shifting from reactive treatment of side effects to proactive prevention based on a patient's genetic blueprint. With further validation and real-world adoption, this test could mark a turning point in how we approach the trade-offs of high-intensity cancer therapies.

For clinicians and health systems navigating treatment options for localized prostate cancer, PROSTOX ultra presents a compelling blend of clinical foresight, patient-centered care, and economic efficiency.