FDA give premarket approval for the Prostate Health Index (Beckman Coulter) to test for Prostate Cancer - 28-Jun-2012

The FDA has given Premarket Approval (PMA) for the Prostate Health Index (PHI), from Beckman Coulter. The PHI test is a non-invasive blood test that is 2.5-times more specific in detecting Prostate Cancer than PSA (prostate-specific antigen) in patients with PSA values in the 4-10 ng/mL range. Typically, physicians recommend that men with a PSA in that range consider a prostate biopsy, however, an elevated PSA may be due to benign conditions other than cancer, which can lead to unnecessary biopsies. Prostate Health Index helps physicians distinguish Prostate Cancer from benign conditions. The approval is based on results of PHI's multi-center clinical study which showed a 31 percent reduction in unnecessary biopsies. Available in Europe since 2010, the PHI will be available in the US in the third quarter of 2012 for use on the company's Access 2 and UniCel DxI immunoassay systems.