CMTR-CHEMTRAK FDA OK Message Board

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Biotech / Medical : CMTR-CHEMTRAK FDA OK

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To: William Presti who wrote (445)	3/4/1997 7:38:00 PM
From: DeadHead	of 1172

Regarding the CLIA waiver, it is permission by the FDA for nurses and other medical personnel other than doctors to administer the test. A CLIA waiver greatly increases the number of people allowed to administer the test and thus reduces the associated costs. As far as I know, Quidel is the only company with a CLIA waiver on its HP test. If Chemtrak's can obtain FDA approval to market its HP test to the home market, then they would have a definate edge over QDEL. In the meantime, QDEL has CLIA approval and CMTR does not.

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