Blood Test Refines Biopsy Decisions in Prostate Cancer

In the U.S., more than a million prostate biopsies are performed each year, yet many do not detect high-grade disease, adding risk, cost, and anxiety for patients. As clinical laboratories seek validated, scalable tools to better stratify risk before biopsy, a new quality management certification now supports a blood-based test designed to help refine these decisions.

Cleveland Diagnostics’ (Cleveland, OH, USA) IsoPSA in vitro diagnostic (IVD) assay has been validated under ISO 13485:2016, the globally recognized quality management standard for medical devices. The certification confirms the company has implemented manufacturing, quality, and operational infrastructure to support scaled commercial production and distribution of the Class III IVD IsoPSA Assay. Building on this designation, the company indicates it is positioned to expand adoption across reference laboratories, health systems, and clinical laboratories nationwide.

IsoPSA is a blood-based test designed to aid in prostate biopsy decision‑making for men aged 50 years and older with elevated prostate-specific antigen (PSA) levels. The assay leverages the company’s IsoClear platform to provide a protein structure‑based risk assessment intended to address diagnostic gaps that lead to unnecessary procedures. The new certification follows recent U.S. Food and Drug Administration approval of the IsoPSA Assay for its stated indication, aligning laboratory quality systems with regulatory clearance for clinical use.

The company notes that prostate cancer remains the second most common cancer in American men and that up to three‑quarters of biopsies may be negative for high‑grade disease, underscoring the need for more precise pre‑biopsy triage. As part of ongoing clinical engagement, the team plans to participate at the American Urological Association Annual Meeting in Washington, D.C., from May 15–18, where research supporting the IsoPSA Assay will be presented. These activities accompany broader organizational initiatives intended to support the assay’s scaled availability.

“When a health system or reference lab evaluates a new diagnostic, they're not just asking if it works, they're asking if the company behind it can deliver,” said Michael Iskra, CEO of Cleveland Diagnostics. “The ISO certification validates the infrastructure we've built to reliably manufacture and distribute the IsoPSA Assay at scale. As the industry shifts toward more precise, clinically actionable testing, the ability to deliver these innovations through standardized, high-quality manufacturing systems is critical.”

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