Clinical Data and Spacelabs Healthcare Enter Partnership to Promote Clinical Data's Drug-Induced Long QT Pharmacogenomics Services.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 ) and Spacelabs Healthcare Clinical Trial Services today announced a partnership to offer Clinical Data's proprietary services related to the testing of drug-induced QT prolongation to Spacelabs' customers through Clinical Data's service division, Cogenics[TM]. This agreement will assist drug development researchers and governmental regulatory agencies in improving the utility of the trials in detecting or ruling out meaningful QT prolonging effects by controlling for genetic variables. The pharmacogenomics analyses will be performed at the New Haven, Conn. laboratories of Clinical Data. Robert Bondaryk, Senior Vice President and General Manager of Cogenics, commented, "More than 50 medications, many of them common, can prolong the QT interval QT interval the portion of an electrocardiogram between the onset of the Q wave and the end of the T wave, representing the total time for ventricular depolarization and repolarization. in otherwise healthy people and cause a form of acquired long QT syndrome The long QT syndrome (LQTS) is a heart condition associated with prolongation of repolarisation (recovery) following depolarisation (excitation) of the cardiac ventricles. It is associated with syncope (fainting) and sudden death due to ventricular arrhythmias. known as drug-induced long QT syndrome. We are very pleased to enter into this collaboration with Spacelabs, who has the ability to provide these services globally. Jim Roop, President, Clinical Trial Services, stated, "We are excited to partner with Cogenics and offer our customer base additional options for meeting the regulatory requirements in their drug development programs. There is much concern in the industry about the problem of Long QT Syndrome. This partnership will allow Spacelabs to incorporate genetic testing Genetic Testing Definition A genetic test examines the genetic information contained inside a person's cells, called DNA, to determine if that person has or will develop a certain disease or could pass a disease to his or her offspring. for drug-induced QT prolongation into all stages of clinical trials, offering our clients the highest level of cardiac safety services." About Long QT Testing Services Drug-induced QT (DI-LQT) prolongation is a leading cause of delays in drug development and drug withdrawals from the market. Over the past few years, several drugs have been pulled from the market as a result of adverse effects related to cardiac safety. In response, regulatory agencies are requesting a definitive or Thorough QT (TQT TQT Task Qualification Training ) study prior to marketing approval. These studies are meant to prevent development expense by either confirming a drug's negligible effect on QT or identifying drugs that seriously impact QT at an early stage. In the event of a positive TQT, ICH See Intel Hub Architecture. E14 recommends that outliers be evaluated for risk factors including genotyping for LQTS LQTS Long QT interval syndrome, see there to identify mutations in people with inherited cardiac channelopathies such as Long QT Syndrome (LQTS) and Brugada Syndrome Brugada syndrome Cardiology A condition in which people with no known heart problems or defects suffer sudden cardiac death or aborted sudden cardiac death EKG Right bundle branch block, persistent ST-segment elevation in V1 to V3 unexplained by electrolyte . Clinical Data's Long QT Testing Services utilize intellectual property from CLDA's proprietary FAMILION([R]) test. The test is performed on blood and identifies mutations in people with inherited cardiac channelopathies by examining the sequences of five cardiac ion channel ion channel n. See channel. genes that have been shown to cause disorders. About Clinical Data, Inc. Clinical Data, Inc. is a global biotechnology company unlocking the potential of molecular discovery, from targeted science to better healthcare. Its PGxHealth division focuses on genetic test and biomarker development to help predict drug safety and efficacy, thereby reducing health care costs and improving clinical outcomes. Its Cogenics division provides molecular and pharmacogenomics services to both research and regulated environments. Its Vital Diagnostics division offers in vitro diagnostics In vitro diagnostic (IVD) tests are medical tests conducted in a test tube, or more generally in a controlled environment outside a living organism. In vitro means in glass in Latin. solutions for the clinical laboratory. Through these divisions, Clinical Data is leveraging advances in molecular discovery to provide tangible benefits for patients, doctors, scientists, and health plans worldwide. About Spacelabs Healthcare, Inc. Spacelabs Healthcare, Inc. (www.spacelabshealthcare.com) is an international developer, manufacturer and distributor of medical equipment and services including solutions for patient monitoring and connectivity, anesthesia delivery and ventilation, diagnostic cardiology and supplies and accessories selling to hospitals, clinics and physician offices. Additionally, the company provides centralized cardiac safety and diagnostic services diagnostic services, n.pl the imaging and laboratory capabilities available for determining the cause of an illness. (ECG ECG electrocardiogram. ECG abbr. 1. electrocardiogram 2. electrocardiograph ECG Also called an electrocardiogram, it records the electrical activity of the heart. , Holter, ABP 1. (networking) ABP - Alternating bit protocol. 2. ABP - Microsoft Address Book Provider. , and Event Monitoring) to biopharmaceutical companies undertaking clinical trials. The company has established brand names in both medical devices and medical services such as "Spacelabs," "Blease" and "Del Mar Reynolds." It employs approximately 1,100 personnel in its offices located in the United States, UK, Canada, France, Germany, Finland, India and Singapore. SAFE HARBOR Safe Harbor 1. A legal provision to reduce or eliminate liability as long as good faith is demonstrated. 2. A form of shark repellent implemented by a target company acquiring a business that is so poorly regulated that the target itself is less attractive. 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 about Clinical Data that is intended to be covered by the safe harbor for "forward-looking statements" provided by the Private Securities Litigation Reform Act of 1995, as amended. 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. These statements include, but are not limited to statements regarding: our ability to successfully integrate the operations, business, technology and intellectual property obtained in our acquisitions; our ability to obtain regulatory approval for, and successfully introduce our new products; our ability to expand our long-term business opportunities; our ability to maintain normal terms with our customers and partners; financial projections and estimates and their underlying assumptions; and statements regarding future performance. All of such statements are subject to certain risks and uncertainties, many 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 our PGxPredict tests will gain wide acceptance in the market; the extent to which genetic markers (haplotypes) are predictive of clinical outcomes and drug efficacy and safety; our ability to achieve the expected synergies and operating efficiencies from all of our acquisitions; the strength of our intellectual property rights; competition from pharmaceutical, biotechnology and diagnostics companies; the development of and our ability to take advantage of the market for pharmacogenetic and biomarker products and services; general economic downturns; and other risks contained in our various SEC reports and filings, including but not limited to our Quarterly Report on Form 10-Q Form 10-Q See 10-Q. for the quarter ended December 31, 2006, and our subsequent Current Reports on Form 8-K filed with the 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, and we do not undertake any obligation to revise and disseminate forward-looking statements to reflect events or circumstances after the date hereof, or to reflect the occurrence of or non-occurrence of any events. Internet Website: www.clda.com |
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