FDA approves Gen-Probe PCA3 test (Progensa)


According to a report today on Xconomy.com, the U.S. Food & Drug Administration has approved the Progensa® PCA3 test developed by Gen-Probe.

Although various versions of the PCA3 test have been available for some time through specialized laboratories, this is the first formal approval of a PCA3 test by the FDA, and will allow Gen-Probe to formally promote and market their brand of the PCA3 test.

According to Gen-Probe, their PCA3 test “can help determine if additional prostate biopsies are warranted for men who had negative results from previous prostate biopsies, but who are nevertheless at higher risk for the disease.”

Another article on this topic is available on the Medscape web site.

4 Responses

  1. Does anyone have any idea when this would be available in Canada?

  2. Hi Tony,

    The second article in hypertext (by Nick Mulcahy) stated that the test was “already approved and marketed in Europe and Canada.”

  3. Some day, everything is gonna be different.

    Wouldn’t it be nice if FDA (web) published their decision on approving the test, ideally with at least citations to supporting data, published studies, any comments on the test, etc.?

    If they have published anything like that, I sure can’t find it.

  4. Dear Dave:

    Since much of the information provided by commercial companies seeking approval of products that they want to bring to market is considered to be proprietary information, the FDA is commonly proscribed from publishing or making any of that information publicly available! Only the company that owns the data has the right to do that (unless they are willing to waive that right).

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