Blood Test Improves Prostate Cancer Detection

A simple blood test that is 2.5 times more specific in detecting prostate cancer than prostate-specific antigen test (PSA) has been officially approved.

The Prostate Health Index (phi) noninvasive blood test is designed specifically for patients with PSA values in the 4-10 ng/mL range and is proven to reduce the number of prostate biopsies.

The test provides an answer to the current PSA testing controversy, where prostate cancer screening to save lives has been weighed against over-diagnosis and over-treatment. The test has Premarket Approval (PMA) from the US Food and Drug Administration (FDA; Silver Spring, MD, USA). In November 2012, the US Preventive Services Task Force (USPSTF; Rockville, MD, USA) issued a statement indicating the need for a better test and better treatment options.

Physicians recommend that men with a PSA in the range of 4-10 ng/mL consider a prostate biopsy; however, an elevated PSA may be due to benign conditions other than cancer, which can lead to unnecessary biopsies. The Prostate Health Index (Beckman Coulter; Brea, CA, USA) helps physicians distinguish prostate cancer from benign conditions.

The results of phi’s multicenter clinical study showed a 31% percent reduction in unnecessary biopsies. Results from a recent health economic study of phi in the US healthcare system suggests the test may help reduce costs associated with prostate cancer detection. The Access Hybritech p2PSA assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of [-2] proPSA antigen, an isoform of free PSA, in human serum using the Access Immunoassay Systems. Available from Beckman Coulter in Europe since 2010, phi will be available in the USA in the third quarter of 2012.

Kevin Slawin, MD, of the Memorial Hermann-Texas Medical Center (Houston, TX, USA) said, “Now, with FDA approval in the US, phi can help physicians discriminate between prostate cancer and benign disease while reducing the number of negative prostate biopsies.” John Blackwood, MS, MBA, vice president of Product Management, Beckman Coulter Diagnostics, added “The Prostate Health Index is the result of years of collaboration with some of the world’s leading prostate cancer researchers and medical institutions who have studied the scientific, clinical and economic benefits of phi."

Related Links:
US Food and Drug Administration
US Preventive Services Task Force
Beckman Coulter