The US Food and Drug Administration (FDA) has granted premarket approval (PMA) to Beckman Coulter's simple, non-invasive Prostate Health Index (phi) blood test.
The phi test, indicated for use in men with a prostate-specific antigen (PSA) value in the range of 4-10 ng/mL, helps physicians to distinguish prostate cancer from benign conditions.
The phi’s multi-center clinical study results showed a 31% reduction in unnecessary biopsies.
US healthcare system’s health economic study results of phi test also suggests that the test may help reduce costs associated with prostate cancer detection.
Urological Research Foundation founder and Northwestern University clinical prostate cancer program director William Catalona said, "Prostate Health Index is a better test because it provides more accurate information physicians and patients need for better decision-making."
phi will be available in the US in the third quarter of 2012 for use on the Beckman’s Access 2 and UniCel DxI immunoassay systems.