New Prostate Screening Test Offers Less Costly, More Accurate Results

In light of new national prostate cancer screening recommendations, a new option is on the horizon for testing for the disease in men.

A new prostate screening test, known as Beckman Coulter's Prostate Health Index or "phi,” received Premarket Approval June 25 from the U.S. Food and Drug Administration.

As the second leading cause of cancer death among men in the United States, prostate cancer is a potentially aggressive disease, and early detection is key to successful treatment.

Current prostate screening methods typically involve what’s known as a PSA blood test to detect the disease. On May 21, the U.S. Preventive Services Task Force issued a statement indicating the need for "a better test and better treatment options.” The panel advised eliminating the routine prostate-specific antigen – or PSA – screening for healthy men because of the test’s controversy over its ability to save lives. New guidelines for prostate cancer screening released by the panel urge doctors not to use the PSA blood test, saying that it is not effective at detecting the disease. At best, the test only helps about one in 1,000 men avoid death from prostate cancer, according to the panel.

In addition, the task force found that up to 50 percent of screened patients with an elevated PSA will have a false-positive reading, leading them to undergo unnecessary biopsies. Men who receive biopsies also face the possibility of infection that can occur after the procedure. A portion of men diagnosed with low risk, screen-detected prostate cancer may then be treated for a cancer that may not have been life-threatening if left undiagnosed or untreated.

The newly approved Prostate Health Index may be able to more accurately identify the disease, researchers say. A simple, noninvasive blood test, the Prostate Health Index is estimated to be 2.5 times more specific in detecting prostate cancer than PSA screening in some patients. The test was also show to have reduced the number of prostate biopsies.

A recent study of phi in the U.S. healthcare system suggests the test may also help decrease costs associated with prostate cancer detection.

PSA screening expert William Catalona, M.D., recently led a multicenter study that confirmed the improved performance of the phi score over the regular PSA or free PSA tests, and published the results in the Journal of Urology.

This precursor form of PSA was jointly discovered by Kevin Slawin, M.D., founder of the Vanguard Urologic Institute and the Texas Prostate Center at Memorial Hermann-Texas Medical Center, and researchers at Beckman Coulter, a developer of biomedical laboratory instruments.

"Our hope is that new options like this test will help to mitigate concerns around screening by reducing the number of unnecessary biopsies, cutting back on the over diagnosis and treatment of prostate cancer, and lowering costs associated with prostate cancer detection,” said Wendy Poage, president of the Prostate Conditions Education Council, in a statement.

The phi test has been available to patients in Europe since 2010 and is expected to be available in the United States later this year.