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Biotech / Medical : CMTR-CHEMTRAK FDA OK

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To: jeeza who wrote (317)2/11/1997 9:51:00 PM
From: surfinSteve   of 1172
 
ChemTrack Files For FDA Clearance Of Test

SUNNYVALE, CA Feb 06 (Reuters) - ChemTrak Inc. said on Monday that it filed with the FDA to obtain marketing clearance for a Helicobacter pylori test.

In 1995, ChemTrak entered into an exclusive distribution and supply agreement for the U.S. market with Astra Merck Inc., a joint venture between Sweden's AB Astra and Merck & Co Inc. The H. pylori test will be marketed as a companion product to Prilosec, which is commonly used to treat ulcers, ChemTrak said. The ChemTrak test will be a one-step, whole blood test that will indicate the presence or absence of H.pylori antibodies in minutes during a doctor's office visit.

The company intends to make the test available to physicians first, then to seek FDA clearance for a consumer self-test similar to ChemTrak's CholesTrak cholesterol test, the company said.
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