The US Food and Drug Administration (FDA) has granted approval for Cleveland Diagnostics’ IsoPSA in vitro diagnostic (IVD) kit, designed as an aid for physicians in deciding on prostate biopsy for men aged 50 years and older who present with elevated prostate-specific antigen (PSA) levels.

The blood-based test was approved via the premarket approval (PMA) process.

The FDA’s decision is supported by clinical evidence from a prospective trial carried out at 14 US sites, as well as data from supporting analytical validation trials.