New PSA Test (Prostate Health Index) Approved by FDA

Men are often told that while the prostate-specific antigen (PSA) test is not perfect nor specific for detecting prostate cancer, it’s the best test available. Now, however, a new PSA test, called the Prostate Health Index (phi), has received premarket approval from the Food and Drug Administration (FDA). The Prostate Health Index was designed to differentiate prostate cancer from noncancer conditions such as benign prostatic hyperplasia and can reduce the need for prostate biopsy.

FDA approval of the new PSA test could not come at a better time, given the recent heated controversy over the recommendation by the United States Preventive Services Task Force (USPSTF) against routine use of the PSA test to screen healthy men for prostate cancer. Many health organizations and experts have questioned the new PSA test recommendations by the USPSTF, and have urged men to consider all their options before making a decision about the PSA test.

The Prostate Health Index, which was developed by Beckman Coulter, is reportedly 2.5 times more specific in the detection of prostate cancer than the current PSA screening test, and reduced the number of unnecessary prostate biopsies performed by 31%, according to clinical trial results. These findings are based on men who had PSA values in the range of 4 to 10 ng/mL, the values at which men are normally advised to have a prostate biopsy.

What’s special about the Prostate Health Index is that it combines three factors: PSA, free PSA, and a new form of the precursor to PSA, called -2 pro PSA. Levels of -2 pro PSA are more elevated in men who have prostate cancer, and so clinicians can more accurately identify prostate cancer.

According to Kevin Slawin, MD, co-founder of -2 pro PSA with researchers at Beckman Coulter, the Prostate Health Index “has the potential to help rebalance the scales in favor of screening–preventing us from losing the considerable ground we’ve gained since PSA was first introduced.” The Prostate Health Index will be available in the United States in the third quarter of 2012.

Read more in our Prostate Cancer Health Center.