The FDA approved Cleveland Diagnostics' blood-based test to help diagnose high-grade prostate tumors and aid in biopsy decisions, the company announced.
Dubbed IsoPSA, the in vitro diagnostic kit is indicated for men ages 50 and older with an elevated prostate-specific antigen (PSA) level. According to the company, the blood-based test analyzes the PSA isoform composition in blood to better determine whether or not elevated PSA comes from cancer cells.
"As a practicing urologist, I see firsthand how the limitations of current PSA testing can lead to unnecessary procedures and anxiety for patients and appreciate the critical need for early and accurate risk assessment and testing," said Aaron Berger, MD, of Associated Urological Specialists in Chicago, in a statement. "IsoPSA represents a meaningful advancement, giving physicians a tool that improves risk assessment and helps us make more informed biopsy decisions with greater confidence."
Approval was supported by a prospective study conducted at 14 U.S. sites and from multiple validation studies.
A laboratory-developed test (LDT) of IsoPSA has been available since 2020 and is included in the National Comprehensive Cancer Network's prostate cancer early detection guidelines and covered by Medicare for eligible beneficiaries.
Multiple studies have supported the LDT.
In a prospective, multicenter study of 888 men scheduled for prostate biopsy, the IsoPSA LDT demonstrated an area under the receiver operating characteristic curve of 0.783 (95% CI 0.752-0.814) for detecting high-grade tumors. Sensitivity reached 90.2% and specificity was 45.5%, while the negative and positive predictive values were 89.3% and 47.7%, respectively.
A real-world observational clinical utility study of the LDT involving 38 providers showed that IsoPSA testing among 900 men ages 50 and up with a PSA of at least 4 ng/mL resulted in a 55% net reduction in recommendations for prostate biopsy.
No comments:
Post a Comment
Note: Only a member of this blog may post a comment.