Ciphergen Biosystems(CIPH): Message Board

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Biotech / Medical : Ciphergen Biosystems(CIPH):

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To: tuck who wrote (350)	7/1/2005 2:04:05 PM
From: tuck	Read Replies (1) of 510

Correlogic's website has been updated. They now give more color: correlogic.com One can surf from there to other parts of the site. What FDA might do is indeed the crux. I believe the FDA is going to call this a medical device because the molecular basis for the test is apparently still unknown. As such, I'd expect the FDA to force the 501k route on Correlogic (dissenting logic welcomed). Ciphergen has published and validated the markers in its test. They told me they intend to commercialize it as an Analyte Specific Reagent of ASR. I'll have to relearn what that means in terms of commercialization. If they can sign someone soon, they can still get it out this year if they don't have to do the 501k route. Edit: This report from last year shows part of the reason they got slowed down. correlogic.com And here's your ASR guidance: fda.gov Since ovarian cancer is not contagious, it should escape Class III labeling, not sure about class II. Edit: OK, should escape class II as well, that seems to be related to blood banking. Cheers, Tuck

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