Cleveland Diagnostics Novel Prostate Cancer Diagnostic Test Granted Breakthrough Device Designation from the FDA

Cleveland Diagnostics’ Novel Prostate Cancer Diagnostic Test Granted Breakthrough Device Designation from the FDA

14:50 EDT 16 Oct 2019 | Speciality Pharma Journal

CLEVELAND–(BUSINESS WIRE)–Cleveland Diagnostics, Inc., a clinical-stage company focused on developing next-generation diagnostic tests for the early detection of cancers, announced today that it has received FDA Breakthrough Device Designation for the IsoPSA® Assay, a novel prostate cancer diagnostic test. Published studies from multicenter prospective clinical trials suggest that the non-invasive, blood-based IsoPSA assay has significant superior …

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