FDA approves blood test to improve prostate Ca detection

July 5, 2012

The FDA recently granted pre-market approval to Prostate Health Index (phi), a noninvasive blood test that manufacturer Beckman Coulter, Inc. claims is 2.5 times more specific in detecting prostate cancer than PSA in patients with PSA values in the 4.0 to 10.0 ng/mL range.

The FDA recently granted pre-market approval to Prostate Health Index (phi), a noninvasive blood test that manufacturer Beckman Coulter, Inc. claims is 2.5 times more specific in detecting prostate cancer than PSA in patients with PSA values in the 4.0 to 10.0 ng/mL range.

"Prostate Health Index is a better test because it provides more accurate information physicians and patients need for better decision making," said William Catalona, MD, of Northwestern University, Chicago. "Now, patients and physicians wondering what to do with an elevated PSA test result in the 4.0 to 10.0 ng/mL range have a new, noninvasive option. This represents an advance in the science of prostate cancer management."

The phi test is indicated for use in men with a PSA in the range of 4.0 to 10.0 ng/mL, and helps physicians distinguish prostate cancer from benign conditions. The results of phi’s multicenter clinical study showed a 31% reduction in unnecessary biopsies, according to Beckman Coulter.

The test will be available in the United States in the third quarter of 2012 for use on the company’s Access 2 and UniCel DxI immunoassay systems.

Dr. Catalona is a consultant/adviser, investigator, and meeting participant/lecturer for Beckman Coulter.

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