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Biotech / Medical : QDEL - Quidel more quick diagnosis
QDEL 24.35+14.3%Nov 21 9:30 AM EST
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To: Brooke who wrote (659)4/21/1997 9:53:00 PM
From: Robert Busse   of 1693
 
Brooke, I'm not sure why Safeplan is not talked about. It is my understanding it is undergoing clinical trials - It had a bit of a false start in 1994 or so when Qdel filed a 510k, but FDA held it was sufficiently different fom anything previously approved and currently on the market and FDA required "pre-market approval" w/ clinical tests. Last summer, I believe, there was an article in WSJIA about a product Unilever had developed which is somewhat similar to Qdel's SafePlan. In the article, it quoted Mark Francois, then Qdel IR director, who said Qdel's product would probably be beaten to market in the US by Unilever product, but Qdel's Safeplan wouldn't be far behind and it was less expensive and easier to use than Unilever's product (which uses some kind of a machine to test urine sample at home - about $75 bucks I think). The Unilever product is currently sold in Europe as "Persona". Please check out unipath.com for more info. Please note it has not been approved yet in US and I don't even think it has been submitted to FDA yet, altho I may be wrong about that. If you have access to Lexis/Nexis, I'm sure you can find some info about Qdel's SafePlan, altho it has been under tight wraps for the last year or so. Why?? That would be a good question for the next one of us who calls the company.
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