The FDA Clears Beckman Coulter’s Prostate Health Index (PHI) Test

 Beckman Coulter, Inc, leader in prostate cancer diagnostics has announced the Premarket Approval from the U.S. Food and Drug Administration (FDA) on the new Prostate Health Index (phi) blood test. The new approved PHI test is 2.5x’s more specific in detecting prostate cancer than the controversial PSA test. It has shown a 31 percent reduction in unnecessary biopsies, and finally provides a new solution and screening tool for men and their physicians.

There has been a mix of confusion and heated arguments over the effectiveness of the well known prostate specific antigen (PSA) test since the United States Preventative Services Task Force (USPSTF) openly gave it a “D” rating. USPSTF stated that the PSA test led to several unnecessary biopsies and ultimately called for “a better test and better treatment options.” U.S. physicians previously recommended that men with a PSA in the range of 4-10ng/mL consider having a prostate biopsy. However, studies further showed that an elevated PSA was because of benign conditions, and not cancer which would lead men to have an unnecessary biopsy. The Prostate Health Index test helps physicians distinguish prostate cancer from these benign conditions.

The PHI test has been available in Europe for nearly 2 years for men with a PSA in the range of 2-10ng/mL, and is now finally available to men in the U.S who are in the 4-10ng/mL range.

The benefit of this test is that it provides men with another option to screening methods, lowers health care cost, reduces the number of unnecessary biopsies, and prevents over diagnosis and treatments. Men with a PSA test result in the range of 4-10ng/mL  now have the option to a new non-invasive treatment option that also proves more effective in the detection of prostate cancer.

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  1. Thanks for starting to tackle this subject. AS you said The Prostate Health Index test helps physicians distinguish prostate cancer from these benign really good invention in medical science.

  2. AL DAILEY says:

    I am post Radical prostatomy.

    Question is the phi test a better way to monitor for metastisis?

    The PSA reading I have had of late are weird to say the least.

    Question. How long before medicare and the insurance companies pay for the test

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