Cleveland Diagnostics Inc., a clinical-stage company producing diagnostic tests for early cancer identification, has been given a significant boost by the federal government. The company announced in a news release on Wednesday, Oct. 16, that it has received U.S. Food & Drug Administration Breakthrough Device Designation for the IsoPSA Assay, a prostate cancer diagnostic test. Medical devices that have the ability to provide more effective care or detection for life-threatening or irreversibly debilitating diseases or disorders are awarded the classification. Cleveland Diagnostics said in the announcement that as a result of obtaining the approval, the organization “must work more closely and more regularly with the FDA to improve its analysis of IsoPSA.” Cleveland Diagnostics said it completed two multicenter clinical trials, directed by Cleveland Clinic, in which IsoPSA’s predictive reliability was contrasted with that of PSA, the existing standard of care for prostate cancer, in prostate biopsy patients. Study results “showed that IsoPSA has superior clinical quality in determining that patients have high-grade disease compared to traditional PSA,” the agency said. Dr. Mark Stovsky, Cleveland Diagnostics ‘ Chief Medical Officer and Clinic urologist, added that PSA’s clinical utility is limited by the test’s relatively poor diagnostic accuracy and predictive value. Today, clinicians use a range of diagnostic tests and procedures to inform decisions about prostate health and prostate cancer risk for a patient. We realize that in this space, IsoPSA has the capability to fill a large void.