Clinical Data Launches Genetic Test for Arrhythmogenic Right Ventricular Cardiomyopathy (ARVC).- Company to release its genetic databases for inherited cardiac conditions - NEWTON, Mass. -- PGxHealth([R]), a division of 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 ), today announced the launch of its new genetic test for Arrhythmogenic Right Ventricular Cardiomyopathy Cardiomyopathy Definition Cardiomyopathy is a chronic disease of the heart muscle (myocardium), in which the muscle is abnormally enlarged, thickened, and/or stiffened. (ARVC ARVC National Association of RV Parks & Campgrounds ARVC Arrhythmogenic Right Ventricular Cardiomyopathy ), an inherited and often fatal heart condition, at the 2008 American Heart Association American Heart Association (AHA), n.pr a national voluntary health agency that has the goal of increasing public and medical awareness of cardiovascular diseases and stroke, and thereby reducing the number of associated deaths and disabilities. meeting. The addition of the FAMILION([R]) ARVC Test expands the Company's FAMILION family of genetic tests for inherited cardiac syndromes and marks its third successful test launch in the past 12 months. Clinical Data also announced plans to make its databases of genetic mutations associated with inherited cardiac conditions, such as ARVC, available to the public. "The launch of our FAMILION ARVC Test illustrates the Company's ongoing commitment to extend our leadership position in cardiovascular genetics by making additional tests more broadly available to clinicians, patients and their family members," said Drew Fromkin, 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. of Clinical Data. "We are also reiterating our commitment to the clinical and research communities and advocacy groups by releasing our cardiac genetic databases to the public in support of efforts to more fully understand the genetic basis of these complex diseases." In 2006, Joint Guidelines released by the American College of Cardiology The American College of Cardiology (ACC) is a nonprofit medical association established in 1949 to educate, research and influence health care public policy. The president for the 2006–2007 year is Steven E. Nissen. [1] The organization has 39 chapters in the U.S. , American Heart Association and the European Society of Cardiology The European Society of Cardiology (ESC) represents more than 50,000 cardiology professionals across Europe and the Mediterranean. Its mission is to reduce the impact of cardiovascular disease in Europe. support the utilization of genetic testing for patients and their family members suspected of carrying mutations causative of ARVC. The FAMILION ARVC Test is a complex genetic test that sequences the five genes most commonly associated with ARVC. "Because over 40 percent of ARVC patients suffer sudden cardiac death Sudden Cardiac Death Definition Sudden cardiac death (SCD) is an unexpected death due to heart problems, which occurs within one hour from the start of any cardiac-related symptoms. SCD is sometimes called cardiac arrest. as their first known manifestation of disease, making an early and accurate diagnosis is critical to saving lives," said Jeffrey Towbin, M.D., Professor, Baylor College of Medicine Baylor College of Medicine is a private medical school located in Houston, Texas, USA on the grounds of the Texas Medical Center. It has been consistently rated the top medical school in Texas and among the best in the United States. and Texas Children's Hospital Texas Children's Hospital is an internationally recognized pediatric hospital located in the Texas Medical Center in Houston. With 639 licensed beds and 465 beds in operation, Texas Children's is the largest children's hospital in the United States. , one of the world's thought leaders on ARVC. "Comprehensive genetic screening that includes all five ARVC causing genes is a critical tool in the diagnosis and management of ARVC." In addition, PGxHealth intends to publish its FAMILION databases beginning in the spring of 2009, as part of a large-scale database project for inherited cardiac conditions. Initially, the publicly accessible data will include information related to 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. (LQTS LQTS Long QT interval syndrome, see there ) and Brugada syndrome (BrS), two inherited channelopathies. "The publication of this large collection of genetic data from approximately 2,500 LQTS and 200 BrS patients, and corresponding data from a healthy reference population of almost 700 volunteers, will be an unprecedented resource for the cardiac research and clinical communities," said Carol R. Reed, M.D., Chief Medical Officer of Clinical Data. "This data release is being carefully assembled in collaboration with multiple academic thought leaders from around the world and will be made available in an anonymous, publicly accessible database, which will be regularly updated with new data from our testing." About ARVC The exact prevalence of ARVC is not known; estimates range from 1 in 5,000 to 1 in 1,250 people.1,2 ARVC is an inherited progressive heart disease with patients most commonly presenting in the second or third decade of life. Symptoms associated with ARVC include syncope syncope Effect of temporary impairment of blood circulation to a part of the body. It is often used as a synonym for fainting, which is loss of consciousness due to inadequate blood flow to the brain. (fainting), heart palpitations, dizziness and breathlessness. While there is no cure for ARVC, once diagnosed and treated, patients have an excellent prognosis. Treatment of confirmed ARVC usually includes implanting a cardioverter defibrillator. The FAMILION ARVC Test will help clinicians interpret borderline clinical findings, confirm the clinical suspicion of ARVC, make presymptomatic diagnoses, identify silent carriers and enable informed genetic counseling. The FAMILION ARVC Test sequences 5 genes (PKP PKP Public Knowledge Project (Canada) PKP Public Key Partners (vendor) PKP Penetrating Keratoplasty (cornea graft) PKP Polskie Koleje Panstwowe 2, DSP (1) (Digital Signal Processor) A special-purpose CPU used for digital signal processing applications (see definition #2 below). It provides ultra-fast instruction sequences, such as shift and add, and multiply and add, which are commonly used in math-intensive , DSG DSG Direct Shift Gearbox (Audi) DSG Dosage DSG Deputy Secretary General DSG Dressing DSG Designate DSG Desmoglein DSG Duke Student Government (Duke University) 2, DSC2 and TMEM TMEM Toyota Motor Engineering & Manufacturing 43) and is performed in a CLIA-certified commercial laboratory that meets all applicable state and federal guidelines. For more information on the FAMILION tests, please contact PGxHealth Customer Service at 877-2-PGxHealth (877-274-9432) or visit its Web site at www.pgxhealth.com. About FAMILION([R]) The FAMILION tests detect genetic mutations that can cause cardiac channelopathies, such as Long QT Syndrome (LQTS), Brugada Syndrome (BrS) and Catecholaminergic Polymorphic Ventricular Tachycardia Catecholaminergic Polymorphic Ventricular Tachycardia (CPVT) is an inherited heart rhythm disorder caused by a mutation in voltage gated ion channels and resulting in arrhythmias. (CPVT CPVT Catecholaminergic Polymorphic Ventricular Tachycardia ), or cardiomyopathies such as Hypertrophic Cardiomyopathy (HCM HCM hypertrophic cardiomyopathy. ) and Arrhythmogenic Right Ventricular Cardiomyopathy (ARVC) in individuals and their families. For more information about the FAMILION family of genetic tests, visit www.pgxhealth.com/genetictests/familion. By detecting genetic mutations, the FAMILION tests can be used to recognize inherited forms of these syndromes, helping to guide treatment and reduce the incidence of deadly cardiac events associated with them. When a cardiac channelopathy or cardiomyopathy has been diagnosed, the test can help doctors and patients make more informed treatment decisions and aid in uncovering other family members that may be at risk, even if asymptomatic. About PGxHealth([R]) PGxHealth has extensive experience and capabilities in the development, clinical validation and delivery of genomics-based tests. Through its own know-how and resources, work conducted with some of the world's most prestigious genomics thought leaders and institutions, and use of innovative technologies, PGxHealth is focused on reducing treatment costs and improving clinical outcomes in disease states and therapeutic classes with expensive, inefficient or suboptimal treatment options. Among its tests are the FAMILION and the PGxPredict([R]) brands. Visit the company's website at www.pgxhealth.com. About Clinical Data, Inc. Clinical Data is a global biotechnology company unlocking the potential of molecular discovery, From Targeted Science to Better Healthcare([R]). Its PGxHealth division focuses on proprietary biomarker and pharmacogenetic test development, as well as targeted therapeutics to help predict drug safety and efficacy, thereby reducing health care costs and improving clinical outcomes. Its Cogenics([R]) division provides genomics services to both research and regulated environments. Through these divisions, Clinical Data is leveraging advances in molecular discovery to provide tangible benefits for patients, doctors, scientists and health plans worldwide. Visit the Company's website at www.clda.com for more information. 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. These statements include, but are not limited to, statements about 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; financial projections and estimates and their underlying assumptions; and statements regarding future performance. All of such information and 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 our PGxPredict[TM] tests, including but not limited to FAMILION, will gain wide acceptance in the market; the extent to which genetic markers (haplotypes) are predictive of clinical outcomes and drug efficacy and safety; 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; whether Clinical Data will be able to develop or acquire additional products and attract new business and strategic partners; and those risks identified and discussed by Clinical Data in its 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 periodic and interim reports, including but not limited to its Annual Report on Form 10-K for the fiscal year ended March 31, 2008, Quarterly Report on Form 10-Q for the fiscal quarter ended September 30, 2008, and Current Reports on Form 8-K filed from time to time by the Company. 1 Muthappan P, Calkins H. Arrhythmogenic right ventricular dysplasia arrhythmogenic right ventricular dysplasia Right ventricular dysplasia, see there . Progressive Cardiovascular Disease. 2008;51:31-43. (2) Peters S. Advances in the diagnostic management of arrhythmogenic right ventricular dysplasia-- cardiomyopathy. International Journal of Cardiology. 2006;113(1):4-11. |
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