FDA approves new test for prostate cancer

FDA approves new test for prostate cancer
FDA approves new test for prostate cancer

The FDA has approved the Prostate Health Index (phi; Beckman Coulter Inc.), a non-invasive blood test that is 2.5-times more specific in detecting prostate cancer than prostate-specific antigen in patients with PSA values in the 4–10 ng/mL range.

The approval comes following a U.S. Preventive Services Task Force (USPSTF) recommendation last month against using PSA-based prostate cancer screening in men regardless of age, after a review showed the potential harms of testing outweighed the benefits. The Task Force issued a statement indicating the need for "a better test and better treatment options."

Typically, physicians recommend that men with PSA levels in 4–10 ng/mL range consider a prostate biopsy, but research shows an elevated PSA may be due to benign conditions other than cancer. This can lead to unnecessary biopsies and adversely affect the patient's quality of life.

The phi test is designed to help physicians distinguish prostate cancer from benign conditions. The results of multi-center clinical study showed that phi reduced unneccessary biopsies by 31%. A separate cost-effectiveness analysis comparing PSA test alone and PSA plus phi at two PSA thresholds (≥2 ng/mL and ≥4 ng/mL), showed that phi saved an estimated $1199 for those with PSA ≥2 ng/mL and $443 for those with PSA ≥4 ng/mL, and resulted in an expected gain of 0.08 or 0.03 quality adjusted life years, respectively.

The phi test will be available in the third quarter of 2012 on the company's Access 2 and UniCel DxI immunoassay systems.

For more information call (800) 526-3821 or visit www.beckmancoulter.com.

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