Clinical Data, Inc. Announces Expanded Reimbursement For Its FAMILION® Long QT Syndrome Genetic Test
Since January 1, 2008, additional private health insurers have adopted positive reimbursement policies related to genetic testing for LQTS, resulting in a total of 65 million lives now covered by these policies, up from 49 million lives at the end of 2007. PGxHealth is now also an approved laboratory provider for Medicaid in 13 states, covering an additional 9 million lives. An additional 24 state Medicaid agencies have indicated that coverage is pending, and applications have been submitted to the remaining 13 states. PGxHealth is also an approved Medicare provider and the FAMILIONLQTS test is reimbursed by Medicare. Plans that have adopted positive coverage policies have determined that the FAMILIONLQTS test is medically necessary for certain patients.
"PGxHealth is committed to providing this important genetic test to patients and physicians, and we are investing significant resources to obtain insurance coverage for patients who need our LQTS test," said Carol Reed, M.D., Executive Vice President and Chief Medical Officer of Clinical Data, Inc. "This growth in private insurance and Medicaid coverage reflects increasing payer acknowledgement of the test's benefits and greater adoption among healthcare providers."
In a recent related development, Clinical Data announced on February 5, 2008 that its FAMILIONLQTS test met the Blue Cross and Blue Shield Association Technology Evaluation Center's (TEC) criteria for establishing the diagnosis of LQTS in certain individuals.
In addition, a guideline issued in 2006 by the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines and the European Society of Cardiology Committee stated, "Genetic analysis is very important for identifying all mutation carriers within an LQTS family. Once identified, silent carriers of LQTS genetic defects may be treated with beta blockers for prophylaxis of life-threatening arrhythmias. Furthermore, silent mutation carriers should receive genetic counseling to learn about the risk of transmitting LQTS to offspring." The guideline also stated, "In patients affected by LQTS, genetic analysis is useful for risk stratification and for making therapeutic decisions."
About FAMILION®
The FAMILIONfamily of 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 FAMILIONtests 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 is a leader in the development of targeted therapeutics and predictive tests from its growing portfolio of proprietary genetic biomarkers. This division of Clinical Data has extensive experience and capabilities in the development, clinical validation and delivery of genetic tests that assist providers in targeting efficacious and safe drugs for their patients. PGxHealth also leverages its capabilities and intellectual property to develop therapeutics which are targeted at patient subpopulations where drug response is enhanced. Through its 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 as Therapeutic Diagnostics™. For more information about PGxHealth, please visit its website at http://www.pgxhealth.com.
About Clinical Data, Inc.
Clinical Data, Inc. is unlocking the potential of molecular discovery from Targeted Science to Better Healthcare™. Its PGxHealth™ 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™ 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.
Clinical Data, Inc.
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 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 December 31, 2007, and Current Reports on Form 8-K filed from time to time by the Company.
Clinical Data, Inc.
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