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GEN News Highlights : Jun 26, 2012

FDA Clears Beckman Coulter’s phi Blood Test for Prostate Cancer

Assay is designed to reduce the need for biopsies in men with PSA levels of 4–10 ng/mL.

FDA approved Beckman Coulter’s Prostate Health Index (phi) blood test for detecting prostate cancer in patients with PSA values in the 4–10 ng/mL range. Men with PSA levels in this range are normally considered for prostate biopsy, even though the PSA elevation may have a benign basis. Beckman Coulter’s phi test is designed to help differentiate prostate cancer from benign conditions and reduce the need for biopsy.

The Prostate Health Index essentially combines three automated blood tests into one index that estimates a man's probability of having prostate cancer found on biopsy. The test thus generates a composite score of Access Hybritech PSA, Access Hybritech free PSA, and Access Hybritech p2PSA.

The firm says the assay is 2.5 times more specific in detecting prostate cancer than PSA in this subset of patients, and in clinical trials reduced the number of unnecessary biopsies carried out by 31%. Phi has been available in Europe since 2010 and will be launched later this year in the U.S. for use on the firm’s Access 2 and UniCel DxI immunoassay systems.