FDA approves Beckman Coulter's prostate blood test

Beckman Coulter has received premarket approval from the FDA for its biomarker-based Prostate Health Index (phi). According to the company, this test is 2.5 times more specific in detecting prostate cancer than PSA (prostate-specific antigen) tests in men with raised levels of PSA, and could cut the number of unnecessary prostate biopsies 31%. This could lead to cuts in healthcare costs, as well as alleviate concerns for the men undergoing the investigation. The test should be launched in the U.S. in the third quarter. In October 2011, the U.S. Preventive Services Task Force (USPSTF) concluded that PSA testing did not offer any survival benefit in men under 75, and in May, the task force recommended that healthy men should not have PSA tests. Beckman Coulter suggests that this test could provide an answer to the controversy. Press release

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