Cleveland Diagnostics’ IsoPSA Test Receives the US FDA Premarket Authorization for Prostate Cancer Diagnosis

Shots: The US FDA has granted a PMA to the IsoPSA in vitro diagnostic (IVD) kit for the diagnosis of high-grade prostate cancer Approval was based on the clinical evidence from a prospective study of the IsoPSA test conducted at 14 sites across the US, as well as data from supporting analytical validation studies IsoPSA, a…