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FDA Grants Breakthrough Designation to Non-Invasive Prostate Cancer Diagnostic Test


The designation is granted to novel medical devices.


Cleveland Diagnostics announced today it received U.S. Food and Drug Administration (FDA) Breakthrough Device Designation for its non-invasive prostate cancer diagnostic test.

The company is focused on developing next-generation diagnostic tests to detect cancer earlier. Through the Breakthrough Device Program, Cleveland Diagnostics will work closely and frequently with the FDA to expedite the review of its device, the IsoPSA Assay.

IsoPSA Assay received breakthrough designation after Cleveland Diagnostics conducted two multicenter clinical trials.

The trials, led by Cleveland Clinic, compared the diagnostic accuracy of IsoPSA Assay to that of a traditional prostate-specific antigen test in men scheduled for prostate biopsy. The results demonstrated that IsoPSA Assay had a better diagnostic performance when identifying which patients have high-grade disease, Cleveland Diagnostics reported.

“The clinical utility of (prostate-specific antigen) is limited by the relatively poor diagnostic accuracy and predictive value of the test,” said Mark Stovsky, M.D., chief medical officer at Cleveland Diagnostics and urologist at Cleveland Clinic. “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.”

IsoPSA Assay could reduce unnecessary biopsies by at least 45% — 500,000 in the U.S. — stopping men from potentially risky and expensive procedures, Cleveland Diagnostics said. What’s more, the medical device could lead to $1 billion in healthcare cost savings, the company claimed.

The FDA grants breakthrough designation to medical devices that could provide more effective treatment or diagnosis of life-threatening or irreversible conditions.

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