ChemTrak Receives FDA Clearance to Market Point-of-Care Assay for Theophylline.SUNNYVALE, Calif.--(BW HealthWire)--Oct. 30, 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 ) announced it has received 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. clearance to market a new point-of-care quantitative assay for theophylline theophylline /the·oph·yl·line/ (the-of´i-lin) a xanthine derivative found in tea leaves and prepared synthetically; its salts and derivatives act as smooth muscle relaxants, central nervous system and cardiac muscle stimulants, and , the Accumeter Theophylline Test. Theophylline is used as a bronchodilator bronchodilator /bron·cho·di·la·tor/ (-di´la-ter) 1. expanding the lumina of the air passages of the lungs. 2. an agent which causes dilatation of the bronchi. and respiratory stimulant by acute and/or chronic asthma sufferers. Frequent blood serum Blood serum A component of blood. Mentioned in: Bites and Stings blood serum the residual fluid of blood after clotting has occurred. It is plasma after the fibrinogen has been removed. concentration monitoring is necessary to ensure optimal dosing and reduce the incidence of serious side effects Side effects Effects of a proposed project on other parts of the firm. that have resulted from changes in the rate of metabolism of the drug. The ChemTrak Accumeter Theophylline Test is a single use, disposable, self contained, noninstrumented technology capable of the quantitative measurement of the drug in whole blood with 99% accuracy. Unlike previous tests, the self contained ChemTrak Theophylline Accumeter Test is designed for use in a physician's office laboratory (POL) at point of care. Tests for theophylline concentration are among the most common blood tests given. Robert First Associates has estimated that about 35 million tests for theophylline serum concentration were performed in the United States in 1990. Bronchodilators Bronchodilators Definition Bronchodilators are medicines that help open the bronchial tubes (airways) of the lungs, allowing more air to flow through them. , such as theophylline are often effective in preventing serious asthma attacks and other breathing problems such as Cheyne-Stokes respirations and apnea/bradycardia episodes in newborns. Theophylline has also been recently documented as an effective anti-inflammatory. "We are very pleased that the FDA has cleared ChemTrak's new Accumeter assay for testing theophylline concentration in whole blood. This Accumeter test is the fourth product we will launch this year and reflects our increasing focus on developing products for the POL market," 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. . "ChemTrak's new test will make it easier to ensure that individualized dosages of theophylline can be prescribed for maximum drug efficacy. As the Accumeter provides rapid results from a simple finger stick sample without the use of a laboratory or any instrumentation, the test can be given and results evaluated by the physician within 15 minutes. We believe that the ease and accuracy of the ChemTrak Accumeter Theophylline Test will lead to its rapid acceptance for POL use," he continued. ChemTrak has successfully launched two products for the home test market in fiscal 1997: ColoCARE(R), a home test to detect the early warning signs of colorectal disease and Parent's Alert(R), Home Drug Test Service to screen for drugs commonly abused by teens. ChemTrak is also introducing its test for H. Pylori to the POL market. H. Pylori is the bacterium associated with duodenal duodenal /du·o·de·nal/ (doo?o-de´n'l) (doo-od´ah-n'l) of or pertaining to the duodenum. Duodenal Refers to the duodenum, or the first part of the small intestine. and peptic ulcers. Located in Sunnyvale, ChemTrak is a full-service medical diagnostics company offering reliable and easy-to-use medical testing systems for in-home use and use in doctors' offices. ChemTrak medical tests are designed to screen and diagnose health conditions with accuracy comparable to physician and laboratory-administered tests. -0- 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 products and pricing, the timely development and acceptance of new products and medical market conditions and other factors discussed in the company's 1996 form 10-K. CONTACT: ChemTrak Inc., Sunnyvale Donald V. Fluken, 408/773-8156 or Self & Associates Trudy M. Self, 818/880-5437 |
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