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| | | ![]() ChemTrak Receives FDA Clearance for Rapid H. Pylori Test SUNNYVALE, Calif., July 2, 1996 -- ChemTrak, Inc.(Nasdaq: CMTR) has received marketing clearance from the U.S. Food and Drug Administration (FDA) for its rapid test for "Helicobacter pylori." One of the most common bacterial infections in humans, H. pylori is thought to be the primary cause of peptic ulcers. 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, Pennsylvania. 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(R) (omeprazole), a leading treatment for ulcers. Prilosec recently "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, for which ChemTrak will seek separate FDA clearance. The H. pylori test utilizes ChemTrak's proprietary AccuMeter(R) 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 minute. 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: Alene A. Holzman, Vice-President of ChemTrak, Inc., 408-773-8156; or Timothy L. Dolan of Freeman/McCue Public Relations, 714-557-3663/ (CMTR)
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