The US Food and Drug Administration has approved a new blood test for prostate cancer, one that has been referred to by its maker as the "answer" to the controversy surrounding the prostate-specific antigen test, or PSA.
The test maker, Beckman Coulter, said that the FDA okayed their premarket approval application for what's being called the Prostate Health Index test. This test uses a measurements of a PSA precursror protein known as [-2] pro-PSA as well as total PSA and free PSA.
This biomarker, [-2] pro-PSA, is believed to be more closely associated with prostate cancer than PSA because it takes all three biomarkers into consideration and determines an index that is more specific than standard PSA testing.
The company carried out a pivotal study that determined that the Prostate Health Index test could cut the number of negative biopsies in patients with positive blood-test results by 31 percent compared to tradtional PSA screening, convincing the FDA to grant premarket approval.
The Prostate Health Index test will be commercially available to patients thus summer in the United States, according to Beckman Coulter.
Source: Medpage Today
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