Clinical Data Receives FDA 510(k) Clearance for Nanopia Wide Range CRP Assay.NEWTON, Mass. -- Clinical Data, 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 : CLDA CLDA California Lyme Disease Association ), a worldwide leader in commercializing pharmacogenomics to guide drug utilization, today announced that its Vital Diagnostics division has received clearance from the Food and Drug Administration to market a wide range C-Reactive Protein C-Reactive Protein Definition C-reactive protein (CRP) is a protein produced by the liver and found in the blood. Purpose C-reactive protein is not normally found in the blood of healthy people. (wrCRP) assay, trademarked as the Nanopia wrCRP Assay. The Nanopia wrCRP is an in vitro in vitro /in vi·tro/ (in ve´tro) [L.] within a glass; observable in a test tube; in an artificial environment. in vi·tro adj. In an artificial environment outside a living organism. diagnostic used for the quantitative measurement of C-Reactive Protein in serum or plasma. C-reactive protein (CRP C-reactive protein (CRP) A protein present in blood serum in various abnormal states, like inflammation. Mentioned in: Pelvic Inflammatory Disease CRP, n.pr See C-reactive protein. ) is a blood component that increases rapidly in infections, tissue trauma, surgery, or other injury to the body. CRP elevates within 4 to 6 hours after the infection or injury occurs. Levels may increase up to 1000 times normal and peak in about 24 to 48 hours. Decreases in CRP occur very rapidly after trauma or infection resolves. The rapid rise and fall of CRP concentrations make it very useful as a nonspecific nonspecific /non·spe·cif·ic/ (non?spi-sif´ik) 1. not due to any single known cause. 2. not directed against a particular agent, but rather having a general effect. nonspecific 1. indicator of acute inflammation acute inflammation n. Inflammation having a rapid onset and coming to a crisis relatively quickly, with a clear and distinct termination. . Elevated CRP occurs in conditions such as bacterial and viral infections, malignancies, tuberculosis, rheumatoid arthritis rheumatoid arthritis Chronic, progressive autoimmune disease causing connective-tissue inflammation, mostly in synovial joints. It can occur at any age, is more common in women, and has an unpredictable course. , and heart attack. Clinical Data's 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. , Israel M. Stein, M.D., said, "We are pleased to have received the necessary 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. 510(k) clearance to market this diagnostic test for high sensitivity C-Reactive Protein high sensitivity C-reactive protein Lab medicine A method of measuring CRP, with higher sensitivity; HSCRP identifies Pts at risk for stroke, cardiovascular and peripheral vascular disease. See C-reactive protein. in the United States. Objective estimates of the U.S. market suggest that over 20 million CRP tests were ordered in 2005 and test use appears to be growing." Dr. Stein continued, "In February 2005, Clinical Data announced that it had entered into a partnering relationship with Daiichi Pure Chemicals, a subsidiary of Daiichi Sankyo of Japan to bring novel technology to the world diagnostics market. Daiichi Pure Chemicals has demonstrated through its long successful history that it has a superior capability for developing unique technology and a firm commitment to serving the needs of the medical diagnostic community. We view Daiichi Pure Chemicals as a perfect partner for this and other specialized applications that are being developed for the clinical chemistry platform. The successful marketing clearance we have received from the FDA for this proprietary Daiichi assay marks the first major milestone for this partnership. Separately, the Company also previously noted that IVD (Interactive VideoDisc) See interactive video. registration under European regulations will also be sought for this assay. About Daiichi Pure Chemicals Co., Ltd. Daiichi Pure Chemicals, Co., Ltd. headquartered in Tokyo, Japan, is a life science company having four business areas: diagnostics, research products, fine chemicals, and contract research. Diagnostics is its core business. Daiichi has developed the homogeneous HDL-C HDL-C high-density-lipoprotein cholesterol. and LDL-C LDL-C low-density-lipoprotein cholesterol reagents and distributes these products worldwide through overseas partner companies. Daiichi has a focus on effective in-vitro testing for life style related diseases, cardiovascular disease Cardiovascular disease Disease that affects the heart and blood vessels. Mentioned in: Lipoproteins Test cardiovascular disease , infectious disease, cancer, thrombosis, and diabetes. Daiichi seeks new business opportunities in the evolving market for diagnostics, and believes the collaboration with Clinical Data, Inc. will contribute to promising business in the future. About Clinical Data, Inc. Clinical Data, Inc. is a worldwide leader in providing molecular services and clinical diagnostics to improve patient care. Clinical Data's molecular services division is among the largest independent providers of pharmacogenomics and metabolomics services globally and consolidates the operations of Genaissance Pharmaceuticals, Inc., Lark Technologies, Inc. and Icoria, Inc., each acquired during 2005. The division is utilizing pharmacogenomics to develop molecular diagnostics and more efficacious therapeutics by finding genetic markers to guide drug development and utilization. These services are marketed to the pharmaceutical, biotech, clinical, academic, government and agricultural marketplaces. Clinical Data's Vital Diagnostics division consolidates the operations of Clinical Data Sales & Service, Inc., Vital Scientific NV, Vital Diagnostics Pty. Ltd., and Electa Lab s.r.l., which are each focused on the small volume clinical diagnostics market worldwide. Vital Diagnostics' instrumentation business has a market focus on the physician's office, hospital and small-to-medium sized laboratory segments. With customers in approximately 100 countries, Vital Diagnostics has also achieved a leading market share for instruments and reagents sold into moderately complex physicians' office laboratories within the United States. SAFE HARBOR STATEMENT UNDER 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 This press release contains certain forward-looking information and statements that are intended to be covered by the safe harbor for forward looking statements provided by the Private Securities Litigation Reform Act of 1995. Forward-looking statements are statements that are not historical facts. Words such as "expect(s)", "feel(s)", "believe(s)", "will", "may", "anticipate(s)" and similar expressions are intended to identify forward-looking statements. Such statements are subject to certain risks and uncertainties, the effects of which are difficult to predict and generally beyond the control of the Company, that could cause actual results to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include, but are not limited to, whether Clinical Data will be able to develop or acquire additional products and attract new business and strategic partners; competition from pharmaceutical, biotechnology and diagnostics companies; the strength of our intellectual property rights; the effect on the Company's operations and results of significant acquisitions or divestitures made by major competitors; the Company's ability to achieve expected synergies and operating efficiencies in all of its acquisitions, and to successfully integrate its operations; and those risks discussed and identified by Clinical Data in its public filings with the U.S. Securities and Exchange Commission. Readers are cautioned not to place undue reliance on these forward-looking statements that speak only as of the date hereof. Clinical Data does not undertake any obligation to republish revised forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. Readers are also urged to carefully review and consider the various disclosures in Clinical Data's SEC reports, including but not limited to its Annual Report on Form 10-KSB for the fiscal year ended March 31, 2005, and fiscal 2005 and 2006 quarterly reports on Forms 10-QSB and 10-Q. |
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