The FDA has approved a novel diagnostic for prostate cancer that looks to improve upon the common screener for prostate-specific antigen, known as a PSA test.
The IsoPSA blood test, developed by Cleveland Diagnostics, looks for specific variants of the PSA protein that can be linked to a higher risk of more malignant disease, instead of simply charting a rise in total PSA levels over time.
In a longitudinal study published earlier this year in the journal Urology, the IsoPSA lab-developed test showed it was able to separate out men ages 50 and older carrying lower risk, allowing some patients to potentially avoid unnecessary biopsy procedures. At the same time, nearly half of patients with an elevated risk went on to develop clinically significant prostate cancer within 30 months, illustrating the need for diligent monitoring within that group.
The company estimates that more than 1 million men undergo prostate biopsies annually, with as many as 75% coming back negative for high-grade cancer.
Cleveland Diagnostics, a Cleveland Clinic portfolio member, has marketed IsoPSA since 2020 as a lab-developed test, following its breakthrough designation from the FDA in 2019. The outfit also partnered with Quest Diagnostics to offer the test in early 2023, and it has received Medicare coverage. The agency’s new premarket approval now allows a version of IsoPSA to be sold as an in vitro diagnostic kit.
“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,” President and CEO Arnon Chait, Ph.D., said in a statement. “We remain focused on executing our commercial strategy and expanding access to IsoPSA, to the benefit of patients nationwide.”
In January 2024, Cleveland Diagnostics raised $75 million to scale up its business and R&D through a financing round led by Novo Nordisk Foundation plus a credit facility from Symbiotic Capital.