Guest guest Posted June 28, 2012 Report Share Posted June 28, 2012 I saw this piece http://www.medpagetoday.com/HematologyOncology/ProstateCancer/33486 which says in part: <snip> A blood test for prostate cancer billed by its manufacturer as " an answer to the current PSA [prostate-specific antigen] testing controversy " has won FDA approval, the company said. Beckman Coulter said Monday that the agency had okayed its premarket approval application for the so-called Prostate Health Index test, which incorporates measurement of a PSA precursor protein called [-2] pro-PSA along with total and free PSA. <snip> Just what is a ‘pre-market approval’? The piece goes on to say <snip> Beckman Coulter said the Prostate Health Index test would be commercially available in the U.S. this summer. It must be performed in labs equipped with the company's immunoassay analyzers. <snip> In looking for information on PCA3 recently, I found a piece that stated that PCA3 had not been approved by the FDA although it could be used by laboratories in the United States as “laboratory developed tests.” I see now that PCA3 was finally approved by FDA in February this year - see http://tinyurl.com/6taryrq or http://www.prnewswire.com/news-releases/fda-approves-progensa-pca3-assay-139349658.html In that piece it mentions that <snip> Gen-Probe submitted a Premarket Approval Application (PMA) to the FDA in August 2010. <snip> So, am I right in thinking that the FDA approval for the PHI - Prostate Health Index test, is in fact a limited one, as the PCA3 test was from August 2010 until February 2012? All the best Prostate men need enlightening, not frightening Terry Herbert - diagnosed in 1996 and still going strong Read A Strange Place for unbiased information at http://www.yananow.org/StrangePlace/index.html Quote Link to comment Share on other sites More sharing options...
Guest guest Posted June 29, 2012 Report Share Posted June 29, 2012 A pre-market approval often abbreviated as PMA means the company can sell their test. The PMA requirements are more difficult than a 510-k, which is what most tests must pass for approval. > > I saw this piece > http://www.medpagetoday.com/HematologyOncology/ProstateCancer/33486 which > says in part: > > > > <snip> A blood test for prostate cancer billed by its manufacturer as " an > answer to the current PSA [prostate-specific antigen] testing controversy " > has won FDA approval, the company said. > > > > Beckman Coulter said Monday that the agency had okayed its premarket > approval application for the so-called Prostate Health Index test, which > incorporates measurement of a PSA precursor protein called [-2] pro-PSA > along with total and free PSA. <snip> > > > > Just what is a 'pre-market approval'? > > > > The piece goes on to say <snip> Beckman Coulter said the Prostate Health > Index test would be commercially available in the U.S. this summer. It must > be performed in labs equipped with the company's immunoassay analyzers. > <snip> > > > > In looking for information on PCA3 recently, I found a piece that stated > that PCA3 had not been approved by the FDA although it could be used by > laboratories in the United States as " laboratory developed tests. " I see now > that PCA3 was finally approved by FDA in February this year - see > http://tinyurl.com/6taryrq or > > http://www.prnewswire.com/news-releases/fda-approves-progensa-pca3-assay-139 > 349658.html > > > > In that piece it mentions that <snip> Gen-Probe submitted a Premarket > Approval Application (PMA) to the FDA in August 2010. <snip> > > > > So, am I right in thinking that the FDA approval for the PHI - Prostate > Health Index test, is in fact a limited one, as the PCA3 test was from > August 2010 until February 2012? > > > > > > All the best > > Prostate men need enlightening, not frightening > > Terry Herbert - diagnosed in 1996 and still going strong > > Read A Strange Place for unbiased information at > http://www.yananow.org/StrangePlace/index.html > <http://www.yananow.net/StrangePlace/index.html> > Quote Link to comment Share on other sites More sharing options...
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