Regulatory milestone positions Cleveland Diagnostics for faster transition from FDA approval to commercial expansion of its novel prostate cancer test

Cleveland Diagnostics, Inc., a commercial-stage precision oncology company, recently received 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 recent FDA approval of the blood-based IsoPSA Assay indicated 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 reference labs, health systems, and clinical labs nationwide.

Prostate cancer is the second most common cancer in American men, with more than one million prostate biopsies performed each year in the U.S. 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,” shared 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.”

The validation is part of a broader wave of momentum for Cleveland Diagnostics, including the recent expansion of its executive leadership team and board. The industry leader will also attend the American Urological Association (AUA) Annual Meeting in D.C. from May 15-18, where the team will connect and collaborate with both clinical and industry partners. Research will also be presented supporting the IsoPSA Assay.

To learn more, visit AUA booth #4111 or head to ClevelandDx.com.

About Cleveland Diagnostics, Inc.

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 revolutionary IsoClear™ platform that enables novel diagnostics based on a cancer-specific, protein structure-based assessment using easy to execute tests within the clinical lab setting. Learn more at ClevelandDx.com and IsoPSA.com.

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"The ISO certification validates the infrastructure we've built to reliably manufacture and distribute the IsoPSA Assay at scale," said Michael Iskra, CEO of Cleveland Diagnostics.