Dr. Weeks’ Comment: Here is the new prostate cancer test. Better? Maybe. More expensive? Yes. Real question… Was this test known about before the PSA test was maligned?
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.
A pivotal, multicenter study sponsored by Beckman Coulter found that the number of negative biopsies in patients with positive blood-test results was reduced by 31% with the Prostate Health Index versus conventional PSA screening, the company said.
The lack of specificity with PSA testing was a major reason why the U.S. Preventive Services Task Force, in a controversial recommendation issued last month, determined that routine PSA-based screening should not be performed in asymptomatic men.
Beckman Coulter said the Prostate Health Index test would be commercially available in the U.S. this summer. It must be performed in labs equipped with the company’s immunoassay analyzers.