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Nov 17 2009, 7:38 AM EST

Clinical Data, Inc. Establishes Scientific Advisory Board for Cardiovascular Genetics

News source: Business Wire

Clinical Data, Inc. (NASDAQ: CLDA) announced today that its PGxHealth division has established a Scientific Advisory Board (SAB) of leading experts in the field of cardiovascular genetics to advise PGxHealth on its FAMILION cardiac genetic research and clinical genetic testing. The SAB will provide PGxHealth with a multidisciplinary perspective on emerging molecular diagnostics and therapeutics to help advance the standard of care for inherited heart disease patients. The Board members are joining PGxHealth at the American Heart Association (AHA) meeting in Orlando, FL, to discuss additional opportunities for educating and promoting inherited heart disease research to the healthcare community.

“We are excited to formalize the relationships that we have cultivated over the years by bringing together in our Scientific Advisory Board these outstanding clinicians and genetic researchers,” said Benjamin Salisbury, Ph.D., Vice President of Clinical Genetics at PGxHealth. “Through our SAB, as well as through our ongoing relationships with other academic and industry collaborators, PGxHealth remains at the forefront of innovative research in this area and will continue to offer the most clinically relevant cardiac genetic tests to healthcare providers.”

The SAB members were chosen for their extensive investigations into the causes of inherited heart diseases, including cardiac channelopathies and cardiomyopathies, and their clinical expertise in treating these diseases. The members of PGxHealth’s Scientific Advisory Board are:

  • Michael Ackerman, M.D., Ph.D., Pediatric Cardiologist at the Mayo Clinic and Director of Mayo's Long QT Syndrome Clinic, as well as Director of the Mayo Clinic Windland Smith Rice Sudden Death Genomics Laboratory;
  • Martin Maron, M.D., Director, Hypertrophic Cardiomyopathy Center, Tufts Medical Center;
  • Silvia Priori, M.D., Ph.D, Professor of Medicine Director of Cardiovascular Genetics, Langone Medical Center, New York University, Associate Professor of Cardiology, Director of Molecular Cardiology, Fondazione Maugeri University of Pavia, Italy;
  • Jeffrey Towbin, M.D., Director of Cardiology and Co-director of Heart Institute at Cincinnati Children’s Hospital, and
  • Arthur Wilde, M.D., Ph.D., Academic Medical Center, Amsterdam, The Netherlands.

In addition to attracting leading experts to its SAB, PGxHealth’s leadership in cardiovascular genetic testing has been underscored by recent events, presentations and publications including:

  • Launch of the sixth FAMILION test, the FAMILION DCM Test for Dilated Cardiomyopathy, an inherited disease which is the leading cause of heart transplants and a possible cause of sudden cardiac death.
  • Oral presentation at AHA 2009, “Evidence that Rare Missense Variants Seen in Long QT Syndrome-susceptibility Genes in Healthy Volunteers are not Pathogenic,” presented in association with Mayo Clinic collaborators.
  • Publication in the current issue of the journal Circulation, “Genetic Testing for Long QT Syndrome – Distinguishing Pathogenic Mutations from Benign Variants.” Results of a multi-center study of Long QT Syndrome, a potentially lethal and highly treatable disorder involving the heart’s electrical system, demonstrate that mutation type and location are critical determinants for distinguishing background noise from true LQTS-causative mutations.
  • Publication in the Heart Rhythm journal, “An International Compendium of Mutations in the SCN5A-Encoded Cardiac Sodium Channel in Patients Referred for Brugada Syndrome Genetic Testing.” A retrospective analysis of Brugada Syndrome (BrS), a common heritable channelopathy, involving an international consortium of databases from 9 genetic testing centers, adds 200 new BrS-associated mutations to the public domain. http://www.heartrhythmjournal.com/article/S1547-5271(09)01142-4/abstract.

PGxHealth is committed to providing patients with access to the FAMILION family of genetic tests and has successfully contracted with major insurance companies, accepts Medicare assignment and is an approved Medicaid provider in certain states. The FAMILION LQTS Test now has coverage policies and agreements that cover over 250 million patients, representing an increase of over 50 million patients in 2009. In-network coverage by private payers also continues to increase, resulting in lower out-of-pocket costs for patients.

For more information about the FAMILION tests, please contact PGxHealth Customer Service at 877-2-PGxHealth (877-274-9432) or visit www.pgxhealth.com.

About PGxHealth®

PGxHealth, a division of Clinical Data, Inc., is utilizing its biomarker expertise and intellectual property to develop and commercialize targeted therapeutics as well as genetic and pharmacogenomic tests that detect serious diseases and help to predict drug safety and efficacy. By using innovative technologies and working with some of the world’s most prestigious genomics thought leaders and institutions, PGxHealth is focused on improving clinical outcomes and reducing treatment costs in disease states and therapeutic classes with expensive, inefficient or suboptimal treatment options. Its tests are marketed under the FAMILION® and PGxPredict® brands. For more information, please visit PGxHealth’s website at www.pgxhealth.com.

About Clinical Data, Inc.

Clinical Data develops first-in-class and best-in-category therapeutics. The Company is advancing its late-stage drug candidates for central nervous system disorders and cardiovascular diseases, to be followed by promising drug candidates in other major therapeutic areas. Clinical Data is also combing its drug development and biomarker expertise to develop products with enhanced efficacy and tolerability to improve patient health and reduce costs. To learn more, please visit the Company's website at www.clda.com.

SAFE HARBOR STATEMENT UNDER THE PRIVATE SECURITIES LITIGATION REFORM ACT 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 obtain regulatory approval for, and successfully introduce our therapeutic and biomarker 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® tests, including but not limited to FAMILION®, will gain wide acceptance in the market; the extent to which genetic markers 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, 2009, Quarterly Report on Form 10-Q for the fiscal quarter ended September 30, 2009, and Current Reports on Form 8-K filed from time to time by the Company.

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