FDA Hands Cleveland Diagnostics’ Prostate Cancer Test Breakthrough Status

October 17, 2019

Cleveland Diagnostics’ IsoPSA Assay, a prostate cancer diagnostic test, has received breakthrough device designation from the FDA.

The non-invasive, blood-based assay’s accuracy is superior to traditional prostate-specific antigen (PSA) tests when detecting high-grade prostate cancer, according to published studies from multicenter prospective trials, Cleveland said.

Clinicians use an array of diagnostic tests and procedures to inform decisions about a patient’s prostate health and the risk of prostate cancer, the company noted, adding it believes the assay “has the potential to fill a major void in this space.”

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