Clinical Data Launches Genetic Test For Hypertrophic Cardiomyopathy
- HCM Affects More Than 600,000 Families in the United States -
NEWTON, Mass. -- Clinical Data, Inc. (NASDAQ:CLDA) announced at the Heart Rhythm Society's annual meeting, 2008 Heart Rhythm, that its PGxHealth(TM) division is adding genetic testing for Hypertrophic Cardiomyopathy (HCM) to its FAMILION([R]) family of genetic tests for cardiac syndromes.
"This new test emphasizes Clinical Data's commitment to being the leader in advancing and marketing genetic tests for inherited cardiac conditions such as HCM," said Drew Fromkin, President & CEO. "It also underscores our focus in applying genetics and biomarker development to difficult to manage clinical problems for which patients and healthcare providers require enhanced tools for diagnostic and treatment decision-making. PGxHealth is also making great strides in advancing its relationship with private and public insurers in order to provide wider access to these important technologies. With our valuable and expanding portfolio of intellectual property, our growing pipeline of tests, and the release of tests such as FAMILION HCM we continue to demonstrate our ability to execute against our business objectives of providing value for the healthcare industry and our shareholders."
PGxHealth's FAMILION([R]) family of tests - which the HCM test will join - is a set of highly complex genetic tests that reveal mutations associated with inherited and potentially lethal cardiac syndromes, including Long QT Syndrome, Brugada Syndrome, Catecholaminergic Polymorhpic Ventricular Tachycardia (commonly referred to as CPVT) and now Hypertrophic Cardiomyopathy. Testing of family members of affected individuals is also available and important to better understand the potential for their exposure to risk from these syndromes.
"Since several other conditions can mimic HCM, genetic testing is key to making an accurate diagnosis. Additionally, genetic testing is the most reliable means of identifying asymptomatic family members that may be unknowingly at risk and enabling caregivers to develop management plans for those family members who are bound to be carriers of the genetic marker for the disease," said Carol R. Reed, M.D., Executive Vice President and Chief Medical Officer of Clinical Data. "Only the FAMILION HCM Test includes analysis of the gene Troponin-C, making it the most complete panel of cardiac sarcomerre genes available."
Joint Guidelines released in 2006 by the American College of Cardiology, American Heart Association and the European Society of Cardiology (Guidelines for the Management of Patients with Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death1) recommend genetic testing for suspected carriers of HCM.
For more information about PGxHealth's Familion HCM or other tests in the Familion family of tests, please visit booth #1238 at 2008 Heart Rhythm, online at www.pgxhealth.com/genetictests/familion, or contact PGxHealth at mhuddleston@pgxhealth.com or 1-877-274-9432.
About Hypertrophic Cardiomyopathy
HCM is the most common form of heart muscle disease, affecting approximately 1 in 500 individuals in the United States, and is the most common cause of sudden cardiac death in people younger than 30 years of age. HCM is characterized by thickening of the heart muscle (hypertrophy) in the absence of an apparent cause such as hypertension. Several other conditions also can result in similar unexplained thickening of the heart muscle, which further complicates diagnosis and management. With the FAMILION HCM test, providers can distinguish HCM from these other conditions, as well as gain a better understanding of the potential for a patient's family members to fall victim to this disorder. While there is no cure, medical management including prescription medications, surgical procedures and/or an implantable cardioverter defibrillator can reduce risk of cardiac events. The FAMILION HCM test analyzes 9 genes associated with HCM, making it the most comprehensive genetic test available for HCM testing.
The clinical presentation and progression of HCM can vary tremendously. Typically, symptoms begin during late childhood and adolescence, although they may not appear until well into adulthood. These symptoms are common to many other conditions and can include breathlessness, especially during exercise, syncope (fainting), heart palpitations and dizziness. An echocardiogram is commonly used to help establish or confirm the diagnosis, but relying solely on the echocardiogram could lead to misdiagnosis. The most reliable diagnosis is achieved with a combination of genetic testing, echocardiogram and electrocardiogram (ECG).
Effectiveness of the FAMILION[R] HCM genetic test for identifying mutations causing HCM
The FAMILION HCM Test consists of sequencing of 9 cardiac sarcomeric genes. It is the only HCM test that includes sequencing of the gene Troponin C, or TNNC1. The clinical sensitivity of the FAMILION HCM Test is 50-60% in patients strongly suspected of having HCM2. The test is performed in a CLIA-certified commercial laboratory that meets all applicable state and federal guidelines. The test has undergone extensive validation conducted by PGxHealth.
About FAMILION([R])
The FAMILION family of tests detects genetic mutations that can cause cardiac channelopathies or hypertrophic cardiomyopathy (HCM). Cardiac channelopathies are rare, potentially lethal heart conditions, including Long QT Syndrome (LQTS), Brugada Syndrome (BrS) and Catecholaminergic Polymorphic Ventricular Tachycardia (CPVT).
By detecting genetic mutations, the FAMILION tests can be used to recognize inherited forms of cardiac channelopathies or HCM in individuals and their families, helping to guide treatment and reduce the deadly cardiac events they can cause.
For cardiac channelopathies that have already been diagnosed, the test can help doctors and patients make more informed treatment decisions and aid in uncovering other possibly asymptomatic family members who are at risk.
For patients suspected of having HCM, the test can help doctors confirm the patient's diagnosis and aid in uncovering asymptomatic family members who are HCM carriers.
About PGxHealth
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 those disease states and therapeutic classes beset with expensive, inefficient or suboptimal treatment options. It has branded its genetic tests based on these proprietary genetic markers Therapeutic Diagnostics[TM]. Visit the company's website at www.pgxhealth.com.
About Clinical Data, Inc.
Clinical Data, Inc. is unlocking the potential of molecular discovery from Targeted Science to Better Healthcare[TM]. Its PGxHealth[TM] 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[TM] 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 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 introduce our new pharmacogenetic and molecular diagnostics products and services; 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[TM] tests and molecular services 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; general economic conditions; and other risks contained in our various SEC reports and filings, including but not limited to our Annual Report on Form 10-K for the fiscal year ended March 31, 2007, our Quarterly Report on Form 10-Q for the fiscal quarter ended December 31, 2007 and our 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.
1 Zipes DP, Camm AJ, Borggrefe M, et al. ACC/AHA/ESC 2006 guidelines for management of patients with ventricular arrhythmias and the prevention of sudden cardiac death-executive summary. J Am Coll Cardiol. 2006;48(5):1065-1102.
2 Keren A, Syrris P and McKenna WJ. Hypertrophic cardiomyopathy:the genetic determinants of clinical disease expression. Nature.2008;5(3): 158-168.
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