GNSC Genaissance Pharmaceuticals (MM)

Genaissance Pharmaceuticals Launches its Proprietary FAMILION(TM) Test for Genetic Mutations Associated With Sudden Cardiac Death Helps Guide Treatment for Cardiac Channelopathies NEW HAVEN, Conn., May 20 /PRNewswire-FirstCall/ -- Genaissance Pharmaceuticals, Inc. announced today the launch of its proprietary FAMILION(TM) Test -- a genetic test for cardiac channelopathies -- at HEART RHYTHM 2004, the Heart Rhythm Society's 25th Annual Scientific Sessions. Cardiac channelopathies is a broad clinical category that includes Long QT and Brugada Syndromes, two causes of arrhythmia that can result in sudden cardiac death. The FAMILION(TM) Test: * Confirms the presence of mutations known to cause cardiac channelopathies; * Identifies family members who have similar mutations; and * Assists physicians in choosing the most appropriate course of treatment for each patient. "The availability of this test will be of tremendous benefit to families and individuals who are or may be affected by one of these inherited causes of cardiac arrhythmias," said G. Michael Vincent, M.D., Professor of Medicine, University of Utah and Chairman of the Department of Medicine at LDS Hospital, Salt Lake City. "The diagnosis by an electrocardiogram is often difficult and may be overlooked, leaving patients at risk for tragic events. This test will help clarify the diagnosis in those persons and allow early and proper treatment and follow up." Dr. Vincent, a cardiologist and a founder of the SADS (Sudden Arrhythmia Death Syndromes) Foundation, has spent much of his career investigating and caring for patients with these disorders. "This launch marks a major milestone for Genaissance for three reasons," said Kevin Rakin, President and Chief Executive Officer of Genaissance Pharmaceuticals, Inc. "First, it demonstrates that we are building a portfolio of proprietary pharmacogenomic products, enabling us to move steadily up the value curve. Second, we view this as further evidence of the steadily increasing shift towards personalized medicine that is now underway, reinforced by the positive regulatory environment for such products. Third, it positions Genaissance to collaborate with pharmaceutical companies to avoid costly drug-induced Long QT problems by applying the FAMILION(TM) Test and our HAP(TM) discovery engine in clinical trials." The value of the FAMILION(TM) Test Patients with symptoms of cardiac channelopathies are typically referred to pediatric cardiologists and electrophysiologists, whom Genaissance will initially target for the FAMILION(TM) Test. The diagnosis of a cardiac channelopathy by an electrocardiogram (ECG) is often difficult and may be missed, which leaves a patient at risk of a sudden cardiac death. The FAMILION(TM) Test will confirm the presence or absence of genetic mutations in five cardiac ion channel genes. Which gene is affected is important, both for clarifying the risk of death and for guiding the treatment of patients and their family members. For example, patients with a mutation in the LQT1 gene have the highest risk of having a cardiac event by the age of 40 and patients with a mutation in LQT3 have the lowest (1). Researchers have also demonstrated that patients with mutations in the LQT1 and LQT2 genes have better outcomes when treated with beta-blocker therapy, while patients with mutations in the LQT3 gene may be better managed with an implantable defibrillator (2). How Physicians will use the FAMILION(TM) Test Physicians will draw a blood sample that will be sent to Genaissance's CLIA-licensed facility in New Haven, Connecticut. Genaissance will extract DNA and sequence (3) five cardiac ion channel genes. Based upon the test results, physicians may recommend to immediate family members that Genaissance also analyze their DNA with the FAMILION(TM) Test for the presence or absence of the specific mutation(s) found in the original patient. Sudden Cardiac Death Long QT and Brugada Syndromes, two types of cardiac channelopathies, are disorders that are typically discovered in the first four decades of life and can be fatal if not diagnosed and treated appropriately. Long QT Syndrome (LQTS) is a condition that impairs the electrical system of the heart. Symptoms of LQTS may include fainting, seizures, abnormal, very fast heartbeats and even death. For some people, these symptoms only occur when they are stressed or taking certain medications. Most of the deaths can be prevented with early diagnosis and treatment of LQTS. People with LQTS have hearts that look and sound normal but may have abnormal electrical activity when examined with an ECG. Some people with LQTS have a normal ECG at rest but experience abnormal responses under certain conditions. For example, these people may have an unusual response when they are startled, experience emotional stress or engage in vigorous physical activities. LQTS can be an inherited or an acquired disorder. Brugada Syndrome is very similar to Long QT Syndrome, however, the characteristic ECG finding is different. Syncope (fainting) is the most common symptom. Ventricular fibrillation, a rapid, irregular heartbeat affecting the lower chambers of the heart, called the ventricles, can also occur. During ventricular fibrillation, blood flow to the body is reduced. If not corrected, ventricular fibrillation can cause death. About Genaissance Pharmaceuticals Genaissance Pharmaceuticals, Inc. is a world leader in the discovery and use of human gene variation for the development of a new generation of DNA-based diagnostic and therapeutic products. Genaissance markets its technology, clinical development skills and pharmacogenomic services as a complete solution for improving the development, marketing and prescribing of drugs. Genaissance offers the FAMILION(TM) Test, a CLIA-compliant genetic test for cardiac channelopathies. Genaissance is headquartered in Science Park in New Haven, Connecticut. Visit the company's website at http://www.genaissance.com/. This press release contains forward-looking statements, including statements about the expected growth and development of Genaissance's business, such as Genaissance's efforts to build a pharmacogenomic franchise around ion channel mutations, the timing and outcome of its genetic testing programs, the ability of Genaissance to apply its technologies to the development, marketing and prescribing of drugs and Genaissance's ability to detect associations between clinical outcomes and genetic variation. Such statements are subject to certain factors, risks and uncertainties that may cause actual results, events and performance to differ materially from those referred to in such statements, including, but not limited to, the extent to which genetic markers (haplotypes) are predictive of clinical outcomes and drug efficacy and safety, the attraction of new business and strategic partners, the adoption of our technologies by the pharmaceutical industry, the acceptance of our cardiac tests by health care providers, the timing and success of clinical trials, competition from pharmaceutical, biotechnology and diagnostics companies, the strength of our intellectual property rights and those risks identified in our Annual Report on Form 10-K filed with the Securities and Exchange Commission on March 30, 2004, and in other filings we make with the Securities and Exchange Commission from time to time. The forward-looking statements contained herein represent the judgment of Genaissance as of the date of this release. Genaissance disclaims any obligation to update any forward-looking statement. (1) Zareba et al. Influence of the Genotype on the Clinical Course of the Long-QT Syndrome. N. Engl. J. Med. 1998; 339: 14: 960-965. (2) Schwartz et al. Genotype-Phenotype Correlation in the Long-QT Syndrome, Gene-Specific Triggers for Life-Threatening Arrhythmias. Circulation. 2001; 103: 89-95. (3) The FAMILION(TM) Test uses the polymerase chain reaction (PCR) to amplify specific regions of DNA. The use of PCR in this test will be performed pursuant to a licensing arrangement with Roche Molecular Systems, Inc. DATASOURCE: Genaissance Pharmaceuticals, Inc. CONTACT: Media - Barbara Askjaer of Feinstein Kean Healthcare, +1-617-577-8110, ; or Kevin Rakin, President & Chief Executive Officer of Genaissance Pharmaceuticals, Inc., +1-203-773-1450, ; or Investors - Rhonda Chiger of Rx Communications, +1-917-322-2569, Web site: http://www.genaissance.com/

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