FDA Approves Cleveland Diagnostics' Next-Gen Prostate Cancer Test, Potentially Reducing Unnecessary Biopsies

Cleveland Diagnostics has received FDA approval for its novel IsoPSA blood test, designed to improve upon traditional prostate-specific antigen (PSA) screening methods for prostate cancer. The test, which analyzes the structure of protein biomarkers rather than just their concentration, aims to help clinicians better determine whether patients with elevated PSA levels should undergo biopsy procedures.

Innovative Approach to Prostate Cancer Detection

The IsoPSA test represents a significant advancement in prostate cancer diagnostics. Unlike conventional PSA tests that measure total PSA levels, IsoPSA identifies specific variants of the PSA protein associated with a higher risk of malignant disease. This approach could potentially reduce the number of unnecessary biopsies performed annually.

Dr. Aaron Berger, chief medical officer and director of clinical research at Associated Urological Specialists in Chicago, emphasized the critical need for such advancements, stating, "As a practicing urologist, I see firsthand how the limitations of current PSA testing can lead to unnecessary procedures and anxiety for patients."

Clinical Evidence and Market Potential

The FDA's approval was based on a study involving nearly 800 patients across 14 U.S. sites, along with supporting analytical validation studies. A longitudinal study published in the journal Urology demonstrated the test's ability to stratify patients into lower and higher risk categories effectively.

Cleveland Diagnostics estimates that over 1 million men undergo prostate biopsies annually, with up to 75% of these procedures coming back negative for high-grade cancer. The company believes IsoPSA could significantly impact this landscape by improving risk assessment and potentially reducing unnecessary interventions.

Commercial Strategy and Financial Backing

IsoPSA has been available since 2020 as a laboratory-developed test, and the recent FDA approval allows Cleveland Diagnostics to distribute test kits to qualified third-party labs nationwide. The company has already partnered with Quest Diagnostics to offer the test and has secured Medicare coverage.

Bob Rochelle, Chief Commercial Officer at Cleveland Diagnostics, expressed confidence in the test's adoption, 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."

In January 2024, Cleveland Diagnostics raised $75 million through a financing round led by the Novo Nordisk Foundation and a credit facility from Symbiotic Capital. This funding is intended to support the scaling up of the company's business operations and research and development efforts.