Beckman Coulter, Inc., the leader in prostate cancer diagnostics, announced Premarket Approval (PMA) from the U.S. Food and Drug Administration (FDA) for the Prostate Health Index (phi), a simple, 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 4-10 ng/mL range and is proven to reduce the number of prostate biopsies.
Beckman Coulter’s new test provides an answer to the current PSA testing controversy, where prostate cancer screening to save lives has been weighed against over-diagnosis and over-treatment. Last month, the U.S. Preventive Services Task Force (USPSTF) issued a statement indicating the need for “a better test and better treatment options.”
The phi testis indicated for use in men with a PSA in the range of 4-10 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. Prostate Health Index helps physicians distinguish prostate cancer from benign conditions. The results of phi’s multi-center clinical study showed a 31 percent reduction in unnecessary biopsies.
Kevin Slawin, M.D., phi researcher and founder of the Vanguard Urologic Institute and theTexasProstateCenteratMemorialHermann-TexasMedicalCenteradded, “Now, with FDA approval in the U. S., phi can help physicians discriminate between prostate cancer and benign disease while reducing the number of negative prostate biopsies.”