Beckman Coulter announces PMA from FDA for Prostate Health Index

Beckman Coulter, Inc., the leader in prostate cancer diagnostics, announces Premarket Approval (PMA) from the U.S. Food and Drug Administration (FDA) for the Prostate Health Index (phi), a simple, non-invasive blood test that is 2.5-times more specific in detecting prostate cancer than PSA (prostate-specific antigen) in patients with PSA values in the 4-10 ng/mL range and is proven to reduce the number of prostate biopsies.

Beckman Coulter's new 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. Last month, the U.S. Preventive Services Task Force (USPSTF) issued a statement indicating the need for "a better test and better treatment options."

"Prostate Health Index is a better test because it provides more accurate information physicians and patients need for better decision-making," said William Catalona, M.D., director of the Clinical Prostate Cancer Program at Northwestern University in Chicago and founder of the Urological Research Foundation. "Now, patients and physicians wondering what to do with an elevated PSA test result in the 4-10 ng/mL range have a new, non-invasive option. This represents an advance in the science of prostate cancer management."

The phi testis indicated for use in men with a PSA in the range of 4-10 ng/mL. Typically, U.S. physicians recommend that men with a PSA in that range consider a prostate biopsy, however, an elevated PSA may be due to benign conditions other than cancer, which can lead to unnecessary biopsies. Prostate Health Index helps physicians distinguish prostate cancer from benign conditions. The results of phi's multi-center clinical study showed a 31 percent reduction in unnecessary biopsies. 

Kevin Slawin, M.D., phi researcher and founder of the Vanguard Urologic Institute and the Texas Prostate Center at Memorial Hermann-Texas Medical Center added, "Now, with FDA approval in the U.S., phi can help physicians discriminate between prostate cancer and benign disease while reducing the number of negative prostate biopsies."

Separately, results from a recent health economic study of phi in the U.S. healthcare system suggests the test may help reduce costs associated with prostate cancer detection.

"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," explained John Blackwood, vice president of Product Management, Beckman Coulter Diagnostics.

Available from Beckman Coulter in Europe since 2010, phi will be available in the U.S. in the third quarter of 2012 for use on the company's Access 2 and UniCel DxI immunoassay systems.

Source:

Beckman Coulter, Inc.

Citations

Please use one of the following formats to cite this article in your essay, paper or report:

  • APA

    Beckman Coulter Diagnostics. (2019, June 19). Beckman Coulter announces PMA from FDA for Prostate Health Index. News-Medical. Retrieved on June 14, 2024 from https://www.news-medical.net/news/20120626/Beckman-Coulter-announces-PMA-from-FDA-for-Prostate-Health-Index.aspx.

  • MLA

    Beckman Coulter Diagnostics. "Beckman Coulter announces PMA from FDA for Prostate Health Index". News-Medical. 14 June 2024. <https://www.news-medical.net/news/20120626/Beckman-Coulter-announces-PMA-from-FDA-for-Prostate-Health-Index.aspx>.

  • Chicago

    Beckman Coulter Diagnostics. "Beckman Coulter announces PMA from FDA for Prostate Health Index". News-Medical. https://www.news-medical.net/news/20120626/Beckman-Coulter-announces-PMA-from-FDA-for-Prostate-Health-Index.aspx. (accessed June 14, 2024).

  • Harvard

    Beckman Coulter Diagnostics. 2019. Beckman Coulter announces PMA from FDA for Prostate Health Index. News-Medical, viewed 14 June 2024, https://www.news-medical.net/news/20120626/Beckman-Coulter-announces-PMA-from-FDA-for-Prostate-Health-Index.aspx.

Comments

The opinions expressed here are the views of the writer and do not necessarily reflect the views and opinions of News Medical.
Post a new comment
Post

While we only use edited and approved content for Azthena answers, it may on occasions provide incorrect responses. Please confirm any data provided with the related suppliers or authors. We do not provide medical advice, if you search for medical information you must always consult a medical professional before acting on any information provided.

Your questions, but not your email details will be shared with OpenAI and retained for 30 days in accordance with their privacy principles.

Please do not ask questions that use sensitive or confidential information.

Read the full Terms & Conditions.

You might also like...
Beckman Coulter brings new thinking to new lab challenges at EuroMedLab 2015