Genetic test for familial Dilated Cardiomyopathy launched by PGxHealth

Nov 16 2009

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^® 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. 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.

"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.