Clinical Data’s FAMILION Test Meets Criteria for Diagnosis of Long QT Syndrome Set By Blue Cross and Blue Shield Association Technology Evaluation Center
PGxHealth™, a division of Clinical Data (NASDAQ:CLDA), a leader in the development of targeted therapeutics and predictive tests from its growing portfolio of proprietary genetic biomarkers, announced today that its FAMILION® test for Long QT Syndrome (LQTS) has met the Blue Cross and Blue Shield Association Technology Evaluation Center’s (TEC) criteria for establishing the diagnosis of LQTS in certain individuals.
TEC completed this assessment at its October 2007 Medical Advisory Panel meeting and posted it in online in January 2008. For more information, please go to: http://www.bcbs.com/betterknowledge/tec/press/genetic-testing-for- long-qt.html (Due to its length, this URL may need to be copied/pasted into your Internet browser’s address field. Remove the extra space if one exists.)
In this assessment, Long QT genetic testing met TEC’s criteria for establishing the diagnosis of LQTS in two types of individuals: those who have a moderate to high pre-test probability of LQTS but do not fully satisfy the clinical criteria, as well as those who meet the clinical criteria for LQTS and have close relatives at-risk. In the latter instance, testing of the individual with LQTS is intended to inform genetic testing options for these relatives. In these populations, the FAMILION test was found to have a positive impact on net health outcomes and a positive diagnostic benefit compared to clinical diagnosis alone.
“Our FAMILION test for the diagnosis of Long QT Syndrome joins the limited number of technologies that have satisfied TEC’s rigorous evaluation, and represents another positive step forward for personalized medicine,” said Drew Fromkin, President and CEO of Clinical Data. “The TEC has a very stringent clinical review process, and health insurers, self-insured organizations, and other payer and provider organizations take note of the TEC’s assessments when evaluating coverage and reimbursement policies for new technologies. We are delighted that the FAMILION LQTS test has been recognized in this way, as we have been working very hard to make the test accessible to the greatest possible number of patients and healthcare providers.”
For More Information on the FAMILION tests contact PGxHealth Customer Service at 877-2-PGxHealth (877-274-9432) or visit its Web site at www.pgxhealth.com.
The Technology Evaluation Center
Founded in 1985 by the Blue Cross and Blue Shield Association, the Technology Evaluation Center pioneered the development of scientific criteria for assessing medical technologies through comprehensive reviews of clinical evidence. TEC operates as part of the Association’s Office of Clinical Affairs and its assessments are scientific opinions, provided solely for informational purposes.
About FAMILION®
The FAMILION tests detect genetic mutations that can cause cardiac channelopathies. These 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 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 that may be at risk.
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 DiagnosticsTM. 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 HealthcareTM. Its PGxHealthTM 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 CogenicsTM 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.
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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™ 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, 2007, Quarterly Report on Form 10-Q for the fiscal quarter ended September 30, 2007, and Current Reports on Form 8-K filed from time to time by the Company.