FDA Grants Premarket Approval to IsoPSA Diagnostic for Prostate Biopsy Decision-Making

FDA Grants ;The U.S. Food and Drug Administration has granted premarket approval to Cleveland Diagnostics’ IsoPSA in vitro diagnostic kit, a blood-based test intended to support biopsy decisions for men aged 50 and older who have elevated PSA levels. 

The new approval follows the company’s previous use of IsoPSA as a laboratory-developed test beginning in 2020, after receiving an FDA breakthrough designation in 2019.

IsoPSA differs from traditional prostate-specific antigen screening by examining structural variants of the PSA protein rather than changes in overall PSA levels. According to a longitudinal study published earlier this year in Urology, the test was able to identify men at lower risk, allowing some individuals to potentially forgo biopsy procedures. 

The same study showed that nearly half of patients classified as having elevated risk later developed clinically significant prostate cancer within 30 months, demonstrating the need for close follow-up in that group.

Cleveland Diagnostics estimates that more than 1 million men in the U.S. undergo prostate biopsies each year, with up to 75% of those tests returning negative for high-grade cancer. The company formed a partnership with Quest Diagnostics in early 2023 to broaden access to IsoPSA and has secured Medicare coverage. With FDA approval, IsoPSA can now be distributed as an in vitro diagnostic kit.

President and CEO Arnon Chait, Ph.D., stated, “FDA approval of our IsoPSA kit marks a significant milestone in Cleveland Diagnostics’ mission to help physicians and patients detect cancer early when it is most treatable and survivable.” He added that the organization remains focused on its commercial plans and on expanding access to the test nationwide.

In January 2024, Cleveland Diagnostics raised $75 million through a financing round led by Novo Nordisk Foundation and through a credit facility from Symbiotic Capital to expand its business and research activities. FDA approval was supported by data from a large prospective study conducted at 14 sites across the U.S., along with supporting analytical validation studies.

Prostate cancer is the second most common cancer among American men, with 1 in 8 diagnosed during their lifetime. More than 1 million biopsies are performed annually, and up to 75% of follow-up tests do not detect high-grade disease.

 Dr. Aaron Berger, a practicing urologist, said that current PSA testing can lead to unnecessary procedures and described IsoPSA as providing improved risk assessment that can help guide biopsy decisions. Dr. Eric Klein noted that the approval represents the outcome of extensive study and development over the past decade.

The IsoPSA IVD kit uses Cleveland Diagnostics’ IsoClear platform, which examines protein biomarkers at a structural level to deliver clinically relevant information. IsoPSA is included in several clinical practice guidelines, including those from the National Comprehensive Cancer Network and the American Urological Association.

FDA Grants Premarket Approval to IsoPSA Diagnostic for Prostate Biopsy Decision-Making

The FDA Grants new opportunities for precision medicine as it officially approves the IsoPSA diagnostic—a cutting-edge, structure-based biomarker test designed to enhance decision-making around prostate biopsies. This advancement marks a major step forward for urology practices and patients seeking clarity in prostate cancer screening.

IsoPSA moves beyond traditional PSA testing by analyzing structural changes in protein biomarkers rather than simply measuring PSA levels. This deeper, molecular-level evaluation allows physicians to better distinguish between high-risk and low-risk disease, ultimately helping them avoid unnecessary biopsies.

With the FDA Grants stamp of approval, healthcare systems can now access a validated tool that offers improved diagnostic accuracy, reduced patient anxiety, and a more informed, evidence-driven approach to prostate cancer management.

Experts note that this approval underscores the FDA’s commitment to modernizing diagnostic pathways. As the FDA Grants clearance to innovative tools like IsoPSA, the future of targeted, efficient cancer screening becomes increasingly attainable for everyone.