DANVILLE, PA and ALAMEDA, CA — February 19, 2008 — Geisinger Health System and Celera (NYSE:CRA), an Applera Corporation business, today announced that they have entered into a research collaboration with the aim of developing a diagnostic assay for the increased risk of non-alcoholic steatohepatitis (NASH). The collaboration will evaluate Celera’s numerous genetic findings in liver diseases, including the Cirrhosis Risk Score™, in the Geisinger bank of more than 600 liver tissue and blood case-control samples donated from patients who have undergone bariatric weight loss surgery. The Geisinger biorespository is among the largest of its kind within a research setting. Financial terms of this multi-year collaboration were not disclosed.
Non-alcoholic fatty liver disease (NAFLD) is a condition where there is accumulation of excess fat in the liver. NAFLD is usually asymptomatic and, as a result, many people don’t know they have the condition until substantial liver damage has occurred. NASH represents an advanced stage of the disease when the accumulated fat results in significant inflammation and scarring. This occurs in approximately a quarter of the patients and can lead to cirrhosis. Ultimately, a liver transplant may be required. Knowledge of those individuals most likely to suffer from this advanced disease could enable closer monitoring of these individuals, leading to overall improved disease management.
NAFLD is linked to metabolic syndrome characterized by diabetes, obesity, and cardiovascular disease. The American College of Gastroenterology estimates that NAFLD affects 2 to 5 percent of Americans and 10 to 20 percent of those who are obese. Elevated serum aminotransferase levels and evidence of insulin resistance are suggestive of early stages of the disease with ultrasound and liver biopsy used in the diagnosis of the disease.
“Even though there are no approved medications for the treatment of NAFLD/ NASH, clinicians strongly encourage patients to lose weight by adopting a low-carbohydrate, low-fat diet and recommend more aggressive control of the often coincident diabetes, dyslipidemia and hypertension,” explained Geisinger scientist Glenn S. Gerhard, M.D.
“Understanding the natural history of NAFLD and NASH, especially identification of those patients with or at risk for NASH represents a critical unmet diagnostic need in liver disease,” said Scott Friedman M.D., Fishberg Professor of Medicine and Chief of Liver Diseases at the Mount Sinai School of Medicine, and a member of the Charles Bronfman Institute for Personalized Medicine. “Associations of disease with various gene variants are beginning to provide keen insight into disease mechanisms that may be shared by multiple diseases.”
“Nonalcoholic fatty liver disease has proven extremely difficult to study, in part because investigators don’t have access to well-characterized samples with information on patient outcomes. Multiple sample sets are vital for the replication of genetic association studies,” said John Sninsky, Ph.D., Vice President, Discovery Research, at Celera.
"Currently a needle liver biopsy is the only way to definitively diagnose the disease so the development of a blood test to detect NAFLD risk would be a tremendous benefit to patients," said Christopher D. Still, DO, Director of the Center for Nutrition and Weight Management and physician researcher on the project.
Jim Peters, Geisinger Ventures Senior Director and CEO of MedMining, Geisinger’s data business, noted, “Together, Geisinger and Celera bring a synergy of experience and expertise to the table.”
According to Geisinger Ventures Director Bryan Allinson, “This academic entrepreneurial collaboration will help advance personalized medicine to practical clinical use, which is all part of Abigail Geisinger’s mission to make patient care ‘The Best’.”
Celera contact: David Speechly, 510-749-1853
Geisinger contact: Patti Urosevich, 570-271-7441
About Geisinger Health System
Founded in 1915, Geisinger Health System (Danville, PA) is one of the nation’s largest integrated health services organizations. Serving more than two million residents throughout central and northeastern Pennsylvania, the physician-led organization is at the forefront of the country's rapidly emerging electronic health records movement. Geisinger is comprised of three medical center campuses, a 700-member group practice, a not-for-profit health insurance company and the Center for Health Research—dedicated to creating innovative new models for patient care, satisfaction and clinical outcomes. Geisinger’s Weis Center for Research focuses innovative research with the goal of advancing patient care and supporting clinical programs. Ongoing research programs investigate a range of topics in obesity, non-alcoholic steatohepatitis, cardiovascular, cancer and other areas. Geisinger Ventures is the innovation and translation driven arm of Geisinger Health System, whose development strategy is based on research and technological driven innovation in targeted clinical areas. MyCode, a research initiative involving the consented collection of blood samples from tens of thousands of patients, provides Geisinger researchers the opportunity to analyze blood and patients’ health information to better understand genetic causes of diseases. For more information, visit www.geisinger.org.
About Applera Corporation and Celera
Applera Corporation consists of two operating groups. Celera is a diagnostics business delivering personalized disease management through a combination of products and services incorporating proprietary discoveries. Berkeley HeartLab, a subsidiary of Celera, offers services to predict cardiovascular disease risk and optimize patient management. Celera also commercializes a wide range of molecular diagnostic products through its strategic alliance with Abbott and has licensed other relevant diagnostic technologies developed to provide personalized disease management in cancer and liver diseases. Applied Biosystems serves the life science industry and research community by developing and marketing instrument-based systems, consumables, software, and services. Customers use these tools to analyze nucleic acids (DNA and RNA), small molecules, and proteins to make scientific discoveries and develop new pharmaceuticals. Applied Biosystems’ products also serve the needs of some markets outside of life science research, which we refer to as “applied markets,” such as the fields of: human identity testing (forensic and paternity testing); biosecurity, which refers to products needed in response to the threat of biological terrorism and other malicious, accidental, and natural biological dangers; and quality and safety testing, such as testing required for food and pharmaceutical manufacturing. Applied Biosystems is headquartered in Foster City, CA, and reported sales of approximately $2.1 billion during fiscal 2007. Information about Applera Corporation, including reports and other information filed by the company with the Securities and Exchange Commission, is available at http://www.applera.com, or by telephoning 800.762.6923. Information about Celera is available at http://www.celera.com.
Celera Forward-Looking Statements
Certain statements in this press release are forward-looking. These may be identified by the use of forward-looking words or phrases such as "believe," "plan," and "should," among others. These forward-looking statements are based on Applera Corporation’s current expectations. The Private Securities Litigation Reform Act of 1995 provides a "safe harbor" for such forward-looking statements. In order to comply with the terms of the safe harbor, Applera notes that a variety of factors could cause actual results and experience to differ materially from the anticipated results or other expectations expressed in such forward-looking statements. These factors include but are not limited to: (1) the risk that clinical trials of products that Celera does discover and develop will not proceed as anticipated or may not be successful, or that such products will not receive required regulatory clearances or approvals; (2) the uncertainty that Celera’s products will be accepted and adopted by the market, including the risk that these products will not be competitive with products offered by other companies, or that users will not be entitled to receive adequate reimbursement for these products from third party payors such as private insurance companies and government insurance plans; (3) legal, ethical, and social issues which could affect demand for Celera’s products; and (4) other factors that might be described from time to time in Applera’s filings with the Securities and Exchange Commission. All information in this press release is as of the date of the release, and Applera does not undertake any duty to update this information, including any forward-looking statements, unless required by law.
Copyright© 2008. Applera Corporation. All rights reserved. Applied Biosystems, Celera and Cirrhosis Risk Score are registered trademarks and Applera is a trademark of Applera Corporation or its subsidiaries in the U.S. and/or certain other countries.