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Biotech / Medical : CMTR-CHEMTRAK FDA OK

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To: William Presti who wrote (530)3/24/1997 12:49:00 PM
From: Leman   of 1172
 
The Business Journal - San Jose Copyright 1997

Monday, March 17, 1997

ChemTrak gets the OK to tout its bacteria test Pete Barlas

Federal regulators say it's OK for ChemTrak Inc. to brag about its test for ulcer-causing bacteria. Thus, it now will be allowed to advertise the fact the diagnostic test is 90 percent accurate.

The Sunnyvale-based medical-device maker last year received approval from the Food and Drug Administration to sell its test for ulcers, but needed the agency's approval to promote its effectiveness.

The disposable test, sold by physicians, hospitals and clinics, is designed to detect heliobacter pylori, a bacteria that can infect the stomach and cause ulcers and cancer.

ChemTrak, known for its home cholesterol test kits, is hoping approval will give the company an edge over its competitors.

"We believe that [the test] is more accurate than other tests on the market," said chief executive Edward Covell.

Quidel Corp. of San Diego and SmithKline Diagnostics Inc. in Palo Alto introduced similar test kits last year.

ChemTrak signed a contract in 1996 with Astra Merk Inc. of Wayne, Pa., to market the tests.

Astra is a joint venture between pharmaceutical giants Merk & Co. Inc. and Astra AB of Sweden.

Astra will sell the ChemTrak test in conjunction with Prilosec, adrug treatment for ulcers. The tests, which sell for around $12, replace invasive endoscopy exams that cost up to $1,500.

The company reported sales of $2.1 billion from Prilosec last year.
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