Beckman Coulter Inc. announced that the FDA has approved Prostate Health Index (phi), 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 4–10ng/mL range and is proven to reduce the number of prostate biopsies.

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 results of phi’s multi-center clinical study showed a 31% reduction in unnecessary biopsies. 

The phi test will be available in the third quarter of 2012 on the company’s Access 2 and UniCel DxI immunoassay systems.

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