ChemTrak reports receipt of FDA response to PMA filing.SUNNYVALE, Calif.--(BW HealthWire)--June 19, 1997--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 ) reported today receiving a response from the 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. ) to the Company's Premarket Approval (PMA PMA (papillary-marginal-attached), n a system of epidemiologic scoring of periodontal disease devised by Schour and Massler in which the symbols denote the areas involved in gingival inflammation. PMA Progressive muscular atrophy ) application for the Aware Home HIV Test Service, requesting additional information. The Company intends to provide a response to the FDA within the standard 180-day time frame set by the agency. "Due to the slower than previously anticipated development of the home HIV test market, preparation of the amended filing will not be the Company's highest priority," said Edward F. Covell, president and CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. . "Instead, we will continue to focus on other opportunities which offer significantly greater short-term market potential. These include our Parents Alert home drug test introduction scheduled for this summer, plus continued market growth in ChemTrak's CholesTrak Home Cholesterol Test, ColoCARE Home Test to Detect the Early Warning Signs of Colorectal Disease, and the test for H. Pylori, the causative agent for many peptic ulcers. In the HIV HIV (Human Immunodeficiency Virus), either of two closely related retroviruses that invade T-helper lymphocytes and are responsible for AIDS. There are two types of HIV: HIV-1 and HIV-2. HIV-1 is responsible for the vast majority of AIDS in the United States. area we will also focus our resources on the international clinical trials for our recently announced AWARE Rapid HIV test." ChemTrak is a full-service personal medical diagnostics company that develops and manufactures reliable and easy-to-use medical testing systems. ChemTrak medical test kits are designed to screen and diagnose health conditions with accuracy comparable to physicians' office and laboratory instrumented tests. Except for the historical information contained herein, this news release contains forward-looking statements that involve risks and uncertainties. Actual results might differ materially from these statements due to risks and uncertainties, including determinations by the FDA, the impact of competitive product and pricing, the timely development and acceptance of new products and medical market conditions and other factors discussed in the Company's 1996 Annual Report on Form 10-K. CONTACT: ChemTrak, Inc. Donald V. Fluken, CFO See Chief Financial Officer. , 408/773-8156 or Neale-May & Partners Bernadette Callahan, 415/328-5555, ext. 120 |
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