The data from multicentre prospective clinical trials demonstrated that the non-invasive, blood-based IsoPSA assay has significant superior diagnostic accuracy compared to traditional prostate-specific antigen (PSA) tests in detecting high-grade prostate cancer.

Cleveland Diagnostics CEO Dr Arnon Chait said: “We are very grateful that FDA recognizes 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.”

IsoPSA Assay is Cleveland Diagnostics’ novel prostate cancer diagnostic test

Cleveland Diagnostics has completed two multicentre clinical trials in major US and international hospitals and clinics.

The studies, which are led by Cleveland Clinic, compared the diagnostic accuracy of IsoPSA with PSA, the current standard of care in prostate cancer, in men scheduled for prostate biopsy.

According to the company, the results of earlier studies demonstrated that IsoPSA could reduce unnecessary biopsies by around 45%, helping men to avoid unnecessary invasive, potentially risky and expensive procedures that may lead to serious and long-term side-effects.

Cleveland Clinic CMO Dr 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.”

Cleveland Diagnostics uses its Solvent Interaction Analysis (SIA) technology to investigate biomarkers at the structural level as opposed to overall concentration, offering better insights as to the protein origin.

Recently, Immuno-Transcriptomics company Novigenix has collaborated with radiopharmaceutical firm RadioMedix for the development of a diagnostic test for neuroendocrine cancer.