Beckman Coulter, the Orange County, Calif.-based biomedical diagnostics products company, has received premarket approval from the FDA for its Prostate Health Index (phi) blood test. The phi test is indicated for use in men with a PSA in the range of 4 to 10 ng/mL, who are normally recommended for biopsy by a physician. A multi-center clinical study showed a 31 percent reduction in unnecessary biopsies when utilizing the phi test, according to Beckman Coulter.
Phi has been available in Europe since 2010 and will be available in the U.S. in the third quarter of 2012.
To learn more about the economics and imaging involved in managing prostate cancer, look for “Prostate Cancer: In the Eye of the Storm” in the Sept./Oct. issue of Health Imaging .