Corgenix Submits FDA Premarket Notification of AspirinWorks(R) Test Kit; New Diagnostic Product to Be Used in Assessing Aspirin Effectiveness.DENVER -- Corgenix Medical Corporation (OTC OTC See: Over-the-counter. OTC See over-the-counter market (OTC). BB: CONX), a worldwide developer and marketer of diagnostic test kits, has submitted a Premarket Notification (510k) to 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 the Company's AspirinWorks(R) Test Kit, the Company's newest diagnostic product for cardiovascular disease Cardiovascular disease Disease that affects the heart and blood vessels. Mentioned in: Lipoproteins Test cardiovascular disease . The AspirinWorks(R) Test Kit is a simple urine test that measures an individual's response to aspirin dosage and allows physicians to adjust the dosage or recommend alternative therapy. Recent reports indicate that up to 25 percent of individuals may be non-responsive to aspirin's benefits, and are more than three times more likely to die from heart disease. "The submission of the AspirinWorks(R) (510k) to the FDA is another important milestone for our Company. We have significant expectations for this product due to the strong interest it has already piqued worldwide," said Douglass Simpson, Corgenix President and Chief Executive Officer. "This new test kit will be sold through our U.S. sales force once we have clearance." The AspirinWorks(R) Test Kit is a quantitative enzyme-linked immunoassay Immunoassay An assay that quantifies antigen or antibody by immunochemical means. The antigen can be a relatively simple substance such as a drug, or a complex one such as a protein or a virus. (ELISA ELISA (e-li´sah) Enzyme-Linked Immuno-Sorbent Assay; any enzyme immunoassay using an enzyme-labeled immunoreactant and an immunosorbent. ELISA n. ) to determine levels of 11-Dehydro Thromboxane thromboxane /throm·box·ane/ (-bok´san) either of two compounds, one designated A2 and the other B2. Thromboxane A2 is synthesized by platelets and is an inducer of platelet aggregation and platelet release functions and is a B2 (11dhTxB2) in human urine, which aids in the assessment of the response to aspirin. The kit was launched internationally in July at the 52nd Annual Scientific and Standardization Committee of the International Society on Thrombosis and Haemostasis hemostasis, haemostasis the stoppage of bleeding or cessation of the circulation of the blood; stagnation of the blood in a part of the body. Also hemostasia, haemostasia. See also: Blood and Blood Vessels Noun 1. held in Oslo, Norway. The AspirinWorks(R) product was developed in conjunction with Corgenix' strategic partners, Creative Clinical Concepts (CCC CCC A very speculative grade assigned to a debt obligation by a rating agency. Such a rating indicates default or considerable doubt that interest will be paid or principal repaid. Also called Caa. ), a Denver based biotechnology company, and Cayman Chemical Company (Cayman), an Ann Arbor, Michigan  “Ann Arbor” redirects here. For other uses, see Ann Arbor (disambiguation). Ann Arbor is a city in the U.S. state of Michigan and the county seat of Washtenaw County. manufacturer of biochemical research products. Corgenix and CCC have previously announced collaboration with McMaster University (McMaster), Hamilton, Ontario. Under terms of a license agreement with McMaster, Corgenix and CCC have exclusive worldwide rights to the proprietary technology owned by McMaster for the development, manufacturing and marketing of innovative diagnostic tests specific to the pathway by which aspirin acts on platelets. The McMaster technology includes several patents pending in the United States, Canada and Europe, and has received notice of allowance of the first of the U.S. patent applications. In addition to licensing the McMaster technology, Corgenix also has a U.S. patent pending on the AspirinWorks(R) product. About Corgenix Medical Corporation Corgenix is a leader in the development and manufacturing of specialized diagnostic kits for immunology disorders, vascular diseases vascular diseases, n.pl diseases of the peripheral circulatory system. and bone and joint disorders. Corgenix diagnostic products are commercialized for use in clinical laboratories throughout the world. The company currently sells over 50 diagnostic products through a global distribution network and has significant experience advancing products through the FDA process. More information is available at www.corgenix.com. Statements in this press release that are not strictly historical facts are "forward looking" statements (identified by the words "believe", "estimate", "project", "expect" or similar expressions) within the meaning of the Private Securities Litigation Reform Act The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and of 1995. These statements inherently involve risks and uncertainties that could cause actual results to differ materially from the forward-looking statements. Factors that would cause or contribute to such differences include, but are not limited to, continued acceptance of the Company's products and services in the marketplace, competitive factors, changes in the regulatory environment, and other risks detailed in the Company's periodic report filings with the Securities and Exchange Commission. The statements in this press release are made as of today, based upon information currently known to management, and the company does not undertake any obligation to publicly update or revise any forward-looking statements. |
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