The quality management certification supports the commercial expansion of the IsoPSA Assay following recent FDA approval.
Cleveland Diagnostics Inc recently received ISO 13485:2016 certification, an international standard for medical device quality management systems. The certification confirms the company has implemented the manufacturing and operational infrastructure necessary for the scaled production of its IsoPSA Assay.
This regulatory milestone follows the recent Food and Drug Administration (FDA) approval of the blood-based IsoPSA Assay. The test is indicated to assist in prostate biopsy decision-making for men aged 50 and older with elevated prostate-specific antigen (PSA) levels. With the ISO certification, the company is positioned to expand commercialization across health systems, reference labs, and clinical labs in the US.
“The ISO certification validates the infrastructure we’ve built to reliably manufacture and distribute the IsoPSA Assay at scale,” says Michael Iskra, CEO of Cleveland Diagnostics, in a release. “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.”
Prostate cancer is the second most common cancer in American men, with more than one million prostate biopsies performed annually in the US. However, up to 75% of those biopsies return negative for high-grade disease, which can lead to invasive procedures and unnecessary costs, according to the company. The IsoPSA Assay uses the company’s IsoClear platform to provide a protein structure-based risk assessment intended to help clinicians inform biopsy decisions.
The company attended the American Urological Association Annual Meeting in Washington, DC, from May 15-18, where it presented research supporting the IsoPSA Assay.
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