ChemTrak receives FDA clearance for rapid H. pylori test.SUNNYVALE, Calif.--(BUSINESS WIRE)--July 2, 1996--ChemTrak Inc. (NASDAQ NASDAQ in full National Association of Securities Dealers Automated Quotations U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on :CMTR CMTR Certified Material Test Report CMTR Combined Marginal Tax Rate ) has received marketing clearance from the U.S. Food and Drug Administration (FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. ) for its rapid test for Helicobacter pylori Helicobacter pylori A gramnegative rod-shaped bacterium that lives in the tissues of the stomach and causes inflammation of the stomach lining. Mentioned in: Indigestion, Ulcers Helicobacter pylori . One of the most common bacterial infections in humans, H. pylori is thought to be the primary cause of peptic ulcers Peptic ulcers Wounds in the stomach and duodenum caused by stomach acid and the bacterium Helicobacter pylori. Mentioned in: Tube Compression of the Esophagus and Stomach . The ChemTrak test is an inexpensive, disposable, single-use, whole-blood vehicle that renders a ``yes'' or ``no'' result on the presence of H. pylori antibodies. The test has received marketing clearance for use by doctors and other clinicians in office or clinical settings. ChemTrak has assigned the U.S. marketing rights for its H. pylori test to Astra Merck Inc., of Wayne, Pa. Astra Merck expects to market the test under the tradename ``Hp Chek'' directly to physicians and clinical institutions as a companion product for its anti-secretory prescription medication Prilosec (omeprazole omeprazole /omep·ra·zole/ (o-mep´ra-zol) an inhibitor of gastric acid secretion used in the treatment of dyspepsia , gastroesophageal reflux disease, disorders of gastric hypersecretion, and peptic ulcer, including that associated with ), a leading treatment for ulcers. Prilosec recently received FDA marketing clearance for use in combination with the antibiotic Biaxin (clarithromycin) of Abbott Laboratories to eradicate H. pylori. ``In the coming months, ChemTrak and Astra Merck will prepare to introduce the test into the professional marketplace,'' said Alene A. Holzman, ChemTrak vice president. ChemTrak's agreement with Astra Merck also grants the right to market the test in the non-prescription, over-the-counter market over-the-counter market Trading in stocks and bonds that does not take place on stock exchanges. Such trading occurs most often in the U.S., where requirements for listing stocks on the exchanges are strict. , for which ChemTrak will seek separate FDA clearance. The H. pylori test utilizes ChemTrak's proprietary AccuMeter technology. The AccuMeter is a small, simple, single-use disposable cassette -- containing all the chemistry necessary to produce test results that are similar in accuracy to laboratory tests. The user places one drop of blood into the AccuMeter; results appear in approximately nine minutes. ChemTrak is a full-service personal diagnostics company that develops and manufactures reliable and easy-to-use medical testing systems. The company markets its products to professional and over-the-counter markets worldwide -- directly and through strategic alliances with established health care and pharmaceutical companies, such as Astra Merck. Statements in this release that relate to product performance, customer acceptance, market conditions and new product plans are forward-looking statements. Actual results might differ materially from these statements due to risks and uncertainties -- including determinations by the FDA, the impact of competitive products and pricing, the timely development and acceptance of new products and medical market conditions. CONTACT: ChemTrak Inc., Sunnyvale Alene A. Holzman, 408/773-8156 or Freeman/McCue Public Relations public relations, activities and policies used to create public interest in a person, idea, product, institution, or business establishment. By its nature, public relations is devoted to serving particular interests by presenting them to the public in the most Timothy L. Dolan, 714/557-3663 |
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