Clinical Data’s PGxHealth Division Launches CPVT Cardiac Channelopathy Test
Clinical Data, Inc.’s (NASDAQ: CLDA) PGxHealthTM division announced today that beginning October 22, 2007 its FAMILION family of genetic tests for cardiac channelopathies will include a test for Catecholaminergic Polymorphic Ventricular Tachycardia (CPVT) mutations. Added in response to requests from doctors using the FAMILION Long QT Syndrome (LQTS) tests, the FAMILION CPVT test is designed to reveal mutations of the cardiac ryanodine receptor gene (RYR2).
The FAMILION family of tests is the only commercially available set of genetic tools that reveal mutations associated with a variety of inherited and potentially lethal cardiac channelopathies, including Long QT Syndrome, Brugada Syndrome (BrS) and CPVT. Additionally, a family testing option exists for each of these conditions.
“CPVT is potentially the most lethal of the inherited cardiac channelopathies. However, in the absence of genetic testing, making a definitive diagnosis can sometimes be challenging. If left untreated, approximately 80% of patients experience cardiac events by the age of 40 while overall mortality ranges from 30%-50%.1 Like LQTS genetic testing, which has matured into a bona-fide clinical test after a decade of research-based testing, clinical CPVT genetic testing now provides cardiologists with an important tool in the diagnostic evaluation and management of patients suspected of having this syndrome,” said Michael Ackerman, M.D., Ph.D., president of the SADS Foundation and director of Mayo Clinic’s Long QT Syndrome Clinic and Windland Smith Rice Sudden Death Genomics Laboratory. “Adding CPVT to the FAMILION family of tests allows doctors to more definitively confirm a diagnosis of CPVT and to identify family members that may be at risk so that treatment options can be considered and the potential risk for cardiac events can be mitigated.”
Carol R. Reed, M.D., Executive Vice President and Chief Medical Officer of Clinical Data said, “The symptoms of CPVT — exercise-induced syncope/seizures/sudden death – closely resemble those of LQTS. Genetic testing can be the key factor in differentiating the two.2 As our FAMILION LQTS test has become more widely adopted, physicians have requested that we add a test for mutations associated with CPVT. Inclusion of this test reflects PGxHealth’s commitment to providing patients and clinicians with tools that have real clinical utility.”
For More Information on the Familion CPVT test Contact: PGxHealth Customer Service at 877-2-PGxHealth (877-274-9432) or visit our Web site at www.pgxhealth.com.
About CPVT
Catecholaminergic Polymorphic Ventricular Tachycardia (CPVT) is an inherited heart rhythm disorder caused by mutations in critical proteins that comprise the calcium release channel (ryanodine receptor) macromolecular complex in the heart. CPVT may cause exercise-induced ventricular arrhythmias and/or syncope occurring during physical activity or acute emotion, but demonstrates no structural problems in the heart. The majority of these events occur during childhood, adolescence, and young adulthood. More than 60% of affected individuals will have a first episode of syncope or cardiac arrest by age 20.1 About 50% of affected individuals harbor a mutation in the RYR2 gene which encodes the pore-forming subunit of the cardiac calcium release channel and forms the basis of the FAMILION CPVT test.
References: 1. Napolitano C, Priori SG. Diagnosis and treatment of catecholaminergic polymorphic ventricular tachycardia. Heart Rhythm. 2007;4:675-678. 2. Liu N, Colombi B, Raytcheva-Buono EV, Bloise R, Priori SG. Catecholaminergic polymorphic ventricular tachycardia. Herz. 2007;32:212-217.
About PGxHealth
PGxHealth has extensive experience and capabilities in the development, clinical validation and delivery of genomics-based tests, in particular of efficacy and safety biomarkers for appropriate drug utilization. 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™. Visit the company’s website at www.pgxhealth.com.
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 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. 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 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; 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 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 June 30, 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.