ChemTrak reports new AWARE Rapid HIV Test meets ELISA/Western Blot accuracy in pre-clinical trials.SUNNYVALE, Calif.--(BW HealthWire)--June 4, 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 ) today reported that it has successfully completed the pre-clinical trials of one-step AWARE(TM) Rapid HIV Test HIV test Various tests have been used to detect HIV and production of antibodies thereto; some HTs shown below are no longer actively used, but are listed for completeness and context. See HIV, Immunoblot. (Rapid HIV Test) with results equivalent to the gold standard ELISA ELISA (e-li´sah) Enzyme-Linked Immuno-Sorbent Assay; any enzyme immunoassay using an enzyme-labeled immunoreactant and an immunosorbent. ELISA n. and Western Blot test Western blot test n. A serum electrophoretic analysis used to identify proteins. methods. The significant differentiating factor: Rapid HIV Test brings accurate HIV test results in three to fifteen minutes utilizing a single drop of blood directly from a finger-stick sample. AWARE(TM) Rapid HIV Test uses the Accumeter(R) technology, the same technology ChemTrak incorporated into its rapid cholesterol and H. Pylori tests under the brand names CholesTrak(R) and HP Chek(R). This innovative system is totally self-contained with a built-in blood separation and metering device as well as all reagents required to perform the test. The pre-clinical trials evaluated 217 clinical specimens providing 100 percent correlation with results obtained from instrument-based ELISA and Western Blot tests. In four commercially available seroconversion seroconversion /se·ro·con·ver·sion/ (-con-ver´zhun) the change of a seronegative test from negative to positive, indicating the development of antibodies in response to immunization or infection. panels, the test detected all the positives with the accuracy of the ELISA and Western Blot tests. The test was found to be highly sensitive by accurately detecting all positives and no cross reactivity was observed with specimens from individuals with non-HIV infections such as Hepatitis B, Hepatitis C, syphilis, HTLV-1, HTLV-2 and CMV CMV cytomegalovirus. CMV abbr. 1. controlled mechanical ventilation 2. cytomegalovirus Cytomegalovirus (CMV) . "We see a real need for a fast, accurate, easy-to-use HIV test kit and made rapid progress in applying the versatile AWARE(TM) technology to an HIV test," said Prithipal Singh, Chairman and Chief Technical Officer of ChemTrak. "The Rapid HIV test will enable point-of-care providers to diagnose and treat the HIV-infected patients immediately, avoiding the cost and delay in sending specimens to a laboratory for instrumented tests. The AWARE(TM) Rapid HIV Test can be performed on-site anywhere in the world, and it is ideal for remote areas." The company anticipates that clinical trials of 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. Rapid Test will commence in two countries outside the United States during the third quarter 1997. ChemTrak plans to initiate clinical trials in the U.S. during the fourth quarter 1997 and anticipates filing for 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. ) clearance for the physicians' office market this year. 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 products and pricing, the timely development and acceptance of new products, medical market conditions and other factors discussed in the company's 1996 Form 10K. CONTACT: ChemTrak, Sunnyvale Donald V. Fluken, 408/773-8156 or Neale-May & Partners Dick Claeys, 415/328-5555, ext. 125 Evelyn Gurzi, 415/328-5555, ext. 108 |
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