Diagnostic tests developer Cleveland Diagnostics has secured breakthrough device designation from the US Food and Drug Administration (FDA) for its IsoPSA Assay to detect prostate cancer.
IsoPSA is a non-invasive, blood-based assay that analyses the structural changes of prostate-specific antigen (PSA), the current standard for prostate cancer detection.
In multi-centre prospective clinical studies, the assay demonstrated superior accuracy in diagnosing high-grade prostate cancer compared to conventional PSA tests, noted the company.
Cleveland Diagnostics CEO Arnon Chait said: “We are very grateful that FDA recognises the potential of IsoPSA, the first test in our pipeline of simple, affordable and highly accurate cancer tests that focus on cancer-relevant changes to protein biomarkers in blood.
“We look forward to working closely with FDA to expedite the appropriate approvals and get this important new test into the hands of physicians.”
Cleveland Diagnostics has completed two multi-centre clinical trials evaluating the IsoPSA Assay in the US. The trials compared the diagnostic accuracy of IsoPSA with PSA in men undergoing prostate biopsy.
According to findings from a clinical validation study reported last year, IsoPSA could have avoided 47% of prostate biopsies. Earlier studies also demonstrated IsoPSA’s ability to reduce over-detection and over-treatment of non-lethal prostate cancer.
Cleveland Diagnostics CMO Mark Stovsky said: “The clinical utility of PSA is limited by the relatively poor diagnostic accuracy and predictive value of the test.
“Clinicians today are using an array of diagnostic tests and procedures to inform decisions about a patient’s prostate health and the risk of prostate cancer. We believe that IsoPSA has the potential to fill a major void in this space.”
The company focuses on developing cost-effective diagnostic tests to detect various diseases. Besides IsoPSA Assay, Cleveland Diagnostics’ portfolio includes tests for breast cancer and Alzheimer’s disease.