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NEWTON, Mass., Nov 16, 2009 (BUSINESS WIRE) -- PGxHealth, a division of Clinical Data, Inc. (NASDAQ: CLDA), today announced the launch of its genetic test for familial Dilated Cardiomyopathy, an inherited heart disease which is the leading cause of heart transplants and a possible cause of sudden cardiac death. The introduction of the FAMILION(R) DCM Test at the 2009 American Heart Association meeting, November 14-17 in Orlando, FL, marks the third significant genetic test launched by PGxHealth over the past 18 months. The FAMILION DCM Test expands the FAMILION family of genetic tests to six index tests used to diagnose or confirm familial heart disease and demonstrates the Company's commitment to extending its leadership position in cardiovascular genetics.
"Unfortunately, the symptoms of DCM manifest during end-stage disease. This limits our ability to intervene earlier in the disease and initiate therapy that can slow disease progression," said Jeffrey Towbin, M.D., Director of Cardiology and Co-director of Heart Institute at Cincinnati Children's Hospital, one of the world's thought leaders on DCM. "Genetic testing may help us find at-risk family members before symptoms present, allowing us to start therapy earlier and successfully slow disease progression."
In 2009, practice guidelines published by the Heart Failure Society of America (HFSA) supported the utilization of genetic testing for patients and their family members suspected of carrying mutations causative of DCM.1 The FAMILION DCM Test is a complex genetic test that sequences the twelve genes most commonly associated with DCM. In addition, the FAMILION DCM Test is the only DCM panel to include SCN5A and ANKRD1, two genes known to account for 5% of gene mutations in familial DCM patients.2,3,4
"Starting with our proprietary FAMILION Long QT Syndrome Test, we have continued to leverage our unique expertise in cardiovascular genetics to provide a comprehensive portfolio of tests for inherited cardiac conditions," said Carol R. Reed, M.D., Chief Medical Officer of Clinical Data. "We remain committed to educating healthcare professionals, payors and patients about the role of genetics in helping to diagnose and better manage these potentially fatal diseases."
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, 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.
About DCM
Familial DCM is an inherited progressive heart disease most commonly presenting in the third or fourth decade of life. Symptoms associated with DCM include syncope (fainting), heart palpitations, dizziness and breathlessness. While there is no cure for DCM, there are treatments that can slow the progression of disease. Treatment options for confirmed DCM can include medication, and/or placement of a pacemaker or implantable cardiac defibrillator.
The FAMILION DCM Test will help clinicians diagnose familial DCM, interpret borderline clinical findings, and identify at-risk family members creating the opportunity for early intervention.
The FAMILION DCM Test sequences 12 genes (LMNA, ANKRD1, TNNC1, SCN5A, TPM1, MYBPC3, ACT1, LDB3, PLN, MYH7, TNNT2, TNNI3) and is performed in a CLIA-certified commercial laboratory that meets all applicable state and federal guidelines.
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(R)
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(R) and PGxPredict(R) 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(R) tests, including but not limited to FAMILION(R), 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.
1Hershberger RE, Lindenfeld J, et al. Genetic evaluation of cardiomyopathy - a heart failure society of America practice guideline. Journal of Cardiac Failure. 2009;15:83-9.
2Duboscq-Bidot L, Charron P, Ruppert V, et al. Mutations in the ANKRD1 gene encoding CARP are responsible for human dilated cardiomyopathy. Eur Heart J. 2009;30:2128-36.
3Moulik M, Vatta M, Witt SH, et al. ANKRD1, the gene encoding cardiac ankyrin repeat protein, is a novel dilated cardiomyopathy gene. J Am Coll Cardiol. 2009 54:325-33.
4Olson TM, Michels VV, Ballew JD, et al. Sodium channel mutations and susceptibility to heart failure and atrial fibrillation. JAMA. 2005;293:447-54.
SOURCE: Clinical Data, Inc.
Clinical Data, Inc.
Theresa McNeely, 617-527-9933 x3373
Vice President
Corporate Communications
Copyright Business Wire 2009