FDA approves Beckman Coulter's ?Prostate Health Index? test ? THE ...

Posted on June 27, 2012 by Sitemaster

According to a media release from Beckman Coulter and a report on the MedPage Today web site, the U.S. Food and Drug Administration has approved marketing of the ?Prostate Health Index? test as a new way to test for risk of prostate cancer.

The Prostate Health Index or phi test combines information from levels of total PSA, free PSA, and a PSA precursor protein known as [-2]pro-PSA. The company claims that this test 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.? However, the utility of this test in clinical practice is still to be clearly demonstrated.

Like the PCA3 test, the phi test will presumably be a test used exclusively by urologists and a few other specialists in an attempt to better identify those men who are at risk for prostate cancer after an initial PSA test. If the use of this test can really reduce the number of prostate biopsies by something like 30 percent (as claimed by Beckman Coulter), then certainly it does have a very real value for this reason alone. What is not at all clear at present is whether this test can offer any meaningful assistance in helping to differentiate between clinically significant prostate cancer that needs treatment and prostate cancer that can simply be monitored under active surveillance.

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