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| New PCA3 Test Approved by FDA |
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| Written by MsSnick24 | |
| 29 May 2012 | |
USPSTF Recommendation Could Benefit PCA3 TestUSPSTF Recommendation Could Benefit PCA3 Test DiagnoCure’s PCA3 test received FDA approval in February 2012 to assess the risk of prostate cancer in men following a prior negative biopsy. The FDA-approved test, Progensa PCA3, is marketed by Gen-Probe (GPRO) and could offer a better alternative to PSA testing. Brian Marckx, CFA Last week brought more positive news for DiagnoCure Inc. (T.CUR) and the Progensa PCA3 prostate cancer test including the final recommendation by the U.S. Preventative Services Task Force (USPSTF) against the use of PSA testing. The USPSTF issued its final recommendation statement against the use of PSA testing on May 21, 2012. The final recommendation was not a surprise as the USPSTF, in late 2011, issued a draft recommendation that healthy men without any symptoms of prostate cancer not receive a PSA test. The final recommendation came after a ~6-month public comment period. The recommendation carries significant weight and can determine whether public (including Medicare) and private health insurers will reimburse for the test. Per the chairwoman of the task force relative to the draft recommendation, “Unfortunately, the evidence now shows that this test does not save men’s lives. This test cannot tell the difference between cancers that will and will not affect a man during his natural lifetime. We need to find one that does.” The Task Force gave the PSA test its lowest rating, D, noting that it does more harm than good. DiagnoCure’s PCA3 test received FDA approval in February 2012 to assess the risk of prostate cancer in men following a prior negative biopsy. The FDA-approved test, Progensa PCA3, is marketed by Gen-Probe (GPRO) and could offer a better alternative to PSA testing. The debate over PSA testing was a hot topic at the American Urological Association meeting, held last week in Atlanta. PCA3 testing was featured in several presentations which included additional positive clinical trial data from a multi-site U.S. study using Progensa PCA3 in the detection of prostate cancer in both first biopsy and repeat biopsy patients.
We cover DiagnoCure with an Outperform rating and $2.25 price target. For a free copy of the full research report, please visit scr.zacks.com. |
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