NEW HAVEN, Conn., Feb. 15 /PRNewswire-FirstCall/ -- Genaissance Pharmaceuticals, Inc. , a leading developer and user of genetic information to help guide medical therapy, said its DNA test, FAMILION(TM), is on its way to becoming a key tool to help physicians save the lives of people who are genetically predisposed to potentially fatal cardiac arrhythmias caused by Long QT Syndrome (LQTS), Brugada Syndrome and related cardiac ion channel diseases or channelopathies.
Since its launch in late spring 2004, the FAMILION(TM) Test has quickly gained acceptance with over 130 patient referrals made by nearly 50 pediatric and adult cardiologists and electrophysiologists. These specialists utilize the test as a vital component in their evaluation and management of patients with symptoms of inherited Long QT Syndrome and other ion channel abnormalities that, if left undetected, can cause sudden cardiac death. Medicare and a significant number of major insurance companies now provide coverage for the Genaissance test.
This is the first commercially available, comprehensive genetic test for a heart rhythm disorder. Instead of waiting six to twelve months or more for results of tests conducted in a research setting, doctors now obtain results in as little as four to six weeks. The FAMILION(TM) test is conducted at Genaissance's CLIA-approved laboratory located in New Haven, CT.
"This genetic test for cardiac ion channel mutations may remove uncertainty for the patients, their families, and their physicians with respect to establishing a diagnosis and can guide the physician in determining the best treatment options," says Michael Ackerman, M.D., Ph.D., Director of the Long QT Syndrome Clinic and Sudden Death Genomics Laboratory at Mayo Clinic.
The diagnosis of LQTS and other channelopathies by an electrocardiogram (ECG) is often difficult and may be missed, which leaves a patient at risk for sudden cardiac death. The Genaissance test helps clarify the diagnosis in these patients by examining five cardiac ion channel genes for a mutation that is likely to cause LQTS or Brugada Syndrome. If a genetic mutation is detected, its type and location can assist the physician in making treatment selections that could include life-style modification, prescription or avoidance of specific classes of drugs or the implantation of a defibrillator.
A patient's family members also benefit from the test because it can identify if they inherited the same mutation as the initially symptomatic patient and may be at risk of a potentially fatal arrhythmia. These relatives often have ambiguous findings on an ECG, while the results of the FAMILION(TM) Test can answer whether or not they carry the familial mutation.
"The FAMILION(TM) Test has had a successful launch as evidenced by its steady growth, particularly in the second half of 2004 when Genaissance booked over $200,000 of test revenue. At the current rate of receipt of four or more test samples each week, along with the reimbursement obtained from a large number of insurance providers, we believe that FAMILION(TM) revenues will continue to grow significantly and contribute to our revenue goals for 2005," stated Kevin Rakin, President and CEO of Genaissance.
Genaissance has a patent estate of more than 50 issued and pending patents in the U.S. and other countries relating to the five cardiac ion channel genes examined by the FAMILION(TM) Test. Significant intellectual property facilitating the FAMILION(TM) Test has been provided by the Mayo Clinic, and Dr. Ackerman is a paid consultant and member of Genaissance Pharmaceuticals' scientific advisory board.
More information regarding the FAMILION(TM) Test can be found at http://www.familion.com/.
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.
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 LQTS, 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.
Genaissance Pharmaceuticals, Inc. is developing innovative products based on its proprietary pharmacogenomic technology and has a revenue-generating business in DNA and pharmacogenomic products and services. Genaissance also markets its proprietary FAMILION(TM) Test, designed to detect mutations responsible for causing Familial Long QT and Brugada Syndromes, two causes of sudden cardiac death. The Company's product development strategy is focused on drug candidates with promising clinical profiles and finding genetic markers to identify a responsive patient population. This strategy enables Genaissance to leverage existing clinical data and, thus, reduce the costs and risks associated with traditional drug development and increase the probability of clinical success and commercialization. The Company's lead therapeutic product, vilazodone for depression, is in Phase II of development. For more information on Genaissance, visit our 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 ability to detect associations between clinical outcomes and genetic variation, the ability to assess how genetic variation can affect drug response, efforts to build a drug candidate pipeline, the timing and outcome of its genetic testing programs, the timing of its ability to enter into drug development collaborations with pharmaceutical companies, 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 Quarterly Report on Form 10- Q for the quarter ended September 30, 2004, filed with the Securities and Exchange Commission on November 15, 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.
Genaissance Pharmaceuticals, Inc.