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Clinical Data Launches Genetic Test For Hypertrophic Cardiomyopathy

Business Wire, May 14, 2008

- HCM Affects More Than 600,000 Families in the United States -

NEWTON, Mass. -- Clinical Data, Inc. (NASDAQ:CLDA) announced at the Heart Rhythm Society's annual meeting, 2008 Heart Rhythm, that its PGxHealth(TM) division is adding genetic testing for Hypertrophic Cardiomyopathy (HCM) to its FAMILION([R]) family of genetic tests for cardiac syndromes.

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"This new test emphasizes Clinical Data's commitment to being the leader in advancing and marketing genetic tests for inherited cardiac conditions such as HCM," said Drew Fromkin, President & CEO. "It also underscores our focus in applying genetics and biomarker development to difficult to manage clinical problems for which patients and healthcare providers require enhanced tools for diagnostic and treatment decision-making. PGxHealth is also making great strides in advancing its relationship with private and public insurers in order to provide wider access to these important technologies. With our valuable and expanding portfolio of intellectual property, our growing pipeline of tests, and the release of tests such as FAMILION HCM we continue to demonstrate our ability to execute against our business objectives of providing value for the healthcare industry and our shareholders."

PGxHealth's FAMILION([R]) family of tests - which the HCM test will join - is a set of highly complex genetic tests that reveal mutations associated with inherited and potentially lethal cardiac syndromes, including Long QT Syndrome, Brugada Syndrome, Catecholaminergic Polymorhpic Ventricular Tachycardia (commonly referred to as CPVT) and now Hypertrophic Cardiomyopathy. Testing of family members of affected individuals is also available and important to better understand the potential for their exposure to risk from these syndromes.

"Since several other conditions can mimic HCM, genetic testing is key to making an accurate diagnosis. Additionally, genetic testing is the most reliable means of identifying asymptomatic family members that may be unknowingly at risk and enabling caregivers to develop management plans for those family members who are bound to be carriers of the genetic marker for the disease," said Carol R. Reed, M.D., Executive Vice President and Chief Medical Officer of Clinical Data. "Only the FAMILION HCM Test includes analysis of the gene Troponin-C, making it the most complete panel of cardiac sarcomerre genes available."

Joint Guidelines released in 2006 by the American College of Cardiology, American Heart Association and the European Society of Cardiology (Guidelines for the Management of Patients with Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death1) recommend genetic testing for suspected carriers of HCM.

For more information about PGxHealth's Familion HCM or other tests in the Familion family of tests, please visit booth #1238 at 2008 Heart Rhythm, online at www.pgxhealth.com/genetictests/familion, or contact PGxHealth at mhuddleston@pgxhealth.com or 1-877-274-9432.

About Hypertrophic Cardiomyopathy

HCM is the most common form of heart muscle disease, affecting approximately 1 in 500 individuals in the United States, and is the most common cause of sudden cardiac death in people younger than 30 years of age. HCM is characterized by thickening of the heart muscle (hypertrophy) in the absence of an apparent cause such as hypertension. Several other conditions also can result in similar unexplained thickening of the heart muscle, which further complicates diagnosis and management. With the FAMILION HCM test, providers can distinguish HCM from these other conditions, as well as gain a better understanding of the potential for a patient's family members to fall victim to this disorder. While there is no cure, medical management including prescription medications, surgical procedures and/or an implantable cardioverter defibrillator can reduce risk of cardiac events. The FAMILION HCM test analyzes 9 genes associated with HCM, making it the most comprehensive genetic test available for HCM testing.

The clinical presentation and progression of HCM can vary tremendously. Typically, symptoms begin during late childhood and adolescence, although they may not appear until well into adulthood. These symptoms are common to many other conditions and can include breathlessness, especially during exercise, syncope (fainting), heart palpitations and dizziness. An echocardiogram is commonly used to help establish or confirm the diagnosis, but relying solely on the echocardiogram could lead to misdiagnosis. The most reliable diagnosis is achieved with a combination of genetic testing, echocardiogram and electrocardiogram (ECG).

Effectiveness of the FAMILION[R] HCM genetic test for identifying mutations causing HCM

The FAMILION HCM Test consists of sequencing of 9 cardiac sarcomeric genes. It is the only HCM test that includes sequencing of the gene Troponin C, or TNNC1. The clinical sensitivity of the FAMILION HCM Test is 50-60% in patients strongly suspected of having HCM2. The test is performed in a CLIA-certified commercial laboratory that meets all applicable state and federal guidelines. The test has undergone extensive validation conducted by PGxHealth.

Business Services Industry

Clinical Data Launches Genetic Test For Hypertrophic Cardiomyopathy

Business Wire, May 14, 2008

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