Health Canada approves use of Gen-Probe PCA3 test


Apparently Health Canada has approved coverage of the use of Gen-Probe’s PCA3 test (Progensa™) as a diagnostic test ” to verify the need for repeat biopsies in men at risk of getting prostate cancer.”

There is no information about this regulatory approval (as yet) on the Gen-Probe web site, but relevant information appears on an investor relations web site.

Apparently, Health Canada will only cover the costs associated with use of Progensa in men who have already had at least one negative biopsy (presumably as a consequence of a suspicious digital rectal exam or an elevated PSA level). The Progensa test was approved in  Europe in 2006, but has yet to be approved for clinical use in the USA.

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