Dive Brief:
- Cleveland Diagnostics said Monday it received Food and Drug Administration approval for a test that analyzes the structure of protein biomarkers in the blood for prostate cancer signals, to aid in determining whether a biopsy is needed.
- The IsoPSA technology is for men aged 50 and older whose results from a traditional prostate-specific antigen blood screening showed elevated PSA levels.
- Elevated PSA levels can be a sign of prostate cancer, but may be caused by other conditions. The IsoPSA test can help clarify whether a patient with an elevated PSA should have a biopsy procedure or can extend the interval between biopsies, Cleveland Diagnostics Chief Commercial Officer Bob Rochelle said in an interview.
Dive Insight:
A tissue biopsy is the only way to diagnose prostate cancer, but as many as 75% of those follow-up tests are negative for high-grade disease, according to Cleveland Diagnostics. The IsoPSA test offers a tool to improve risk assessment.
“It looks at the structure of proteins in the blood, rather than mere concentration” like the standard PSA test, Rochelle said. While concentration can be a cancer indicator, he said, there are often „a lot of false positive results“ because of the poor specificity.
Aaron Berger, chief medical officer and director of clinical research at Associated Urological Specialists in Chicago, said there is a critical need for early and accurate risk assessment and testing.
“As a practicing urologist, I see firsthand how the limitations of current PSA testing can lead to unnecessary procedures and anxiety for patients,” Berger said in a company statement.
Cleveland Diagnostics’ test received FDA approval based on results from a study of nearly 800 patients conducted at 14 U.S. sites and data from supporting analytical validation studies.
The IsoPSA test has been available since 2020 as a laboratory developed test. FDA approval allows the company to distribute test kits to third-party labs around the country that are qualified to run high complexity tests, Rochelle said.
“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,” he said.
