Beckman Coulter, Inc, recently announced Premarket Approval from the FDA for the Prostate Health Index, a simple, noninvasive blood test that is 2.5 times more specific in detecting prostate cancer than prostate-specific antigen (PSA) in patients with PSA values in the 4 to 10 ng/mL range and has been shown to reduce the number of prostate biopsies.
The test is indicated for use in men with a PSA in the range of 4 to 10 ng/mL. Typically, U.S. 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. According to Beckman Coulter, the Prostate Health Index helps physicians distinguish prostate cancer from benign conditions. The results of a multicenter clinical study showed a 31% reduction in unnecessary biopsies with the use of the new test.
Separately, results from a recent health economic study of the Prostate Health Index in the U.S. health-care system suggests the test may help reduce costs associated with prostate cancer detection.
Available from Beckman Coulter in Europe since 2010, the test will be available in the United States in the third quarter of 2012 for use on the company’s Access 2 and UniCel DxI immunoassay systems. ■