Cleveland Diagnostics Secures FDA Approval for Novel Prostate Cancer Test

Cleveland Diagnostics has received Food and Drug Administration (FDA) approval for its innovative prostate cancer test, IsoPSA, marking a significant advancement in prostate cancer diagnostics. The test, designed for men aged 50 and older with elevated prostate-specific antigen (PSA) levels, aims to improve risk assessment and reduce unnecessary biopsies.

IsoPSA: A New Approach to Prostate Cancer Detection

IsoPSA represents a departure from traditional PSA testing by analyzing the structure of protein biomarkers in the blood rather than merely their concentration. This novel approach is intended to enhance specificity and reduce false-positive results often associated with standard PSA tests.

Bob Rochelle, Chief Commercial Officer at Cleveland Diagnostics, explained, "It looks at the structure of proteins in the blood, rather than mere concentration like the standard PSA test." He added that while concentration can indicate cancer, it often leads to "a lot of false positive results" due to poor specificity.

Clinical Validation and Market Potential

The FDA's approval was based on a comprehensive study involving nearly 800 patients across 14 U.S. sites, along with supporting analytical validation studies. The test has been available since 2020 as a laboratory-developed test, but the recent FDA approval allows for wider distribution of test kits to qualified high-complexity laboratories nationwide.

Rochelle expressed confidence in the test's market potential, stating, "We're very confident, given the exposure to the test over the last three or four years in the marketplace, that the IVD version of the test will be rapidly adopted as well."

Addressing a Critical Need in Urology

The introduction of IsoPSA addresses a significant challenge in prostate cancer diagnostics. Current estimates suggest that up to 75% of follow-up biopsies performed after elevated PSA results are negative for high-grade disease, highlighting the need for more accurate risk assessment tools.

Dr. Aaron Berger, Chief Medical Officer and Director of Clinical Research at Associated Urological Specialists in Chicago, emphasized this need: "As a practicing urologist, I see firsthand how the limitations of current PSA testing can lead to unnecessary procedures and anxiety for patients."

The IsoPSA test is positioned to help clarify whether patients with elevated PSA levels should proceed with a biopsy or can safely extend the interval between biopsies, potentially reducing unnecessary procedures and patient anxiety.