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Monday, July 2, 2012
FDA OKs New Prostate Cancer Blood Test
A blood test for prostate cancer billed by its manufacturer as "an answer to the current PSA [prostate-specific antigen] testing controversy" has won FDA approval, the company said.
Beckman Coulter said Monday that the agency had okayed its premarket approval application for the so-called Prostate Health Index test, which incorporates measurement of a PSA precursor protein called [-2] pro-PSA along with total and free PSA.
The test is indicated for men with regular PSA test results in the range of 4ng/mL to 10 ng/mL, just above the upper limit of normal.
According to the co-discoverer of [-2] pro-PSA, Kevin Slawin, MD, of Memorial Hermann-Texas Medical Center in Houston, the marker is more closely associated with prostate cancer than total and free PSA. Combining the three markers makes the Prostate Health Index more specific than conventional PSA testing.