ISO 13485:2016 Certification Awarded to Cleveland Diagnostics

Cleveland Diagnostics Inc. has earned ISO 13485:2016 certification, the globally recognized standard for medical device quality management systems. The certification validates that Cleveland Diagnostics has implemented the manufacturing, quality, and operational infrastructure required to support scaled commercial production and distribution of its Class III IVD medical device, IsoPSA Assay.

This milestone builds directly on the company’s U.S. Food and Drug Administration approval of the blood-based IsoPSA Assay to aid in prostate biopsy decision-making for men 50 and older with elevated PSA levels. With ISO 13485 certification in place, the company is positioned to scale commercialization and accelerate adoption of its IsoPSA Assay across U.S. reference labs, health systems, and clinical labs.

Prostate cancer is the second most common cancer in American men, with more than 1 million prostate biopsies performed annually in the United States. However, up to 75% of those biopsies return negative for high-grade disease, subjecting patients to invasive procedures, unnecessary costs, and anxiety. IsoPSA, which leverages the company’s IsoClear platform, addresses this diagnostic gap by giving clinicians a more accurate, protein structure-based risk assessment to inform biopsy decisions with greater confidence.

“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,” Cleveland Diagnostics CEO Michael Iskra said. “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.”

The validation is part of a broader wave of momentum for Cleveland Diagnostics, including the recent expansion of its executive leadership team and board.

Cleveland Diagnostics is a precision oncology company focused on changing the shape of cancer detection. The company has unlocked the diagnostic power of protein structure with its IsoClear platform, which enables novel diagnostics based on a cancer-specific, protein structure-based assessment using easy-to-execute tests within the clinical lab setting.