Celera Diagnostics Discovers Genetic Markers Linked to Heart Attacks
Dr. John Kane Presents Data at International Symposium on Atherosclerosis; Findings Validate Celera Diagnostics’ Discovery Approach
Alameda, CA - September 30, 2003
Celera Diagnostics, a joint venture between the Applied Biosystems Group (NYSE:ABI) and Celera Genomics Group (NYSE:CRA) of Applera Corporation, today announced the discovery of several novel genetic markers associated with an increased risk for myocardial infarction (MI), or heart attack. Selected findings from one of Celera Diagnostics’ cardiovascular disease studies were presented today at the 13th International Symposium on Atherosclerosis in Kyoto, Japan. The presenter was a collaborator in the study, John P. Kane, M.D., Ph.D., Professor of Medicine and Biochemistry, and Associate Director of the Cardiovascular Research Institute (CVRI) at the University of California, San Francisco (UCSF).
The retrospective study identified a collection of genetic variations known as single nucleotide polymorphisms (SNPs) that are predictive of increased risk for heart attack. The study discovered several novel genetic markers, including one that is believed to be involved in inflammation and another that is correlated with increased severity of cardiovascular disease in people under age 60. In addition, the study also confirmed the association between seven previously identified markers and coronary heart disease.
“This study, and others underway at Celera Diagnostics, can provide valuable insights into genetic contributions to coronary heart disease,” said Dr. Kane. “Large scale studies, with well-characterized samples from carefully selected patients, hold significant promise to enable the development of new diagnostics and targeted therapeutics.”
The study drew on a large collection of deeply annotated DNA samples—the Genomic Resource in Arteriosclerosis in the UCSF CVRI—and examined 14,000 functional SNPs in genes from all the human chromosomes. These SNPs were analyzed in properly consented samples from 340 individuals with previous history of MI, and over 500 control samples obtained from people without a history of MI or acute angina. The associations between SNPs and heart attacks identified using samples from UCSF were subsequently confirmed in another large collection of samples.
Celera Diagnostics intends to complete further statistical analysis of the data from this study in order to evaluate the diagnostic and therapeutic potential of these markers. Furthermore, it is conducting additional studies of cardiovascular disease with different sample sets.
The UCSF research activities for this study were funded in part by Celera Diagnostics, and in part by a UC Discovery Grant from the Industry-University Cooperative Research Program (IUCRP), a three-way partnership between the University of California, industry sponsors and the State of California.
Celera Diagnostics’ Discovery Research Approach
Celera Diagnostics compares genotype and/or gene expression profiles in samples from healthy and affected individuals to associate genetic markers with disease. To cost-effectively complete genome-wide scans, Celera Diagnostics operates an industrial-scale facility and utilizes proprietary data and know-how, including novel functional SNPs discovered by the Applera Genomics Initiative. Functional SNPs are those most likely to affect the function, amount or stability of proteins. Celera Diagnostics is currently conducting large-scale disease association studies for nine common, complex diseases, including four forms of cardiovascular disease, breast cancer, rheumatoid arthritis, Alzheimer’s disease, Interferon responsiveness, and a metabolic disease. Celera Diagnostics expects that findings from certain studies currently under way will be presented before the end of calendar 2003.
Genetic markers associated with disease may be used by Celera Diagnostics to develop new molecular diagnostic products. These products may indicate the risk or presence of disease before symptoms appear, predict the severity or expected rate of progression of a disease, or aid in monitoring response to therapy. Some validated markers may also be drug targets. Markers that are potentially tractable drug targets are expected to be evaluated by Celera Genomics, possibly in partnership with other collaborators.
“In order for genetic marker studies to translate into diagnostic tests with significant medical impact, discovery study results must be reproducible and applicable to a wide group of people,” said Tom White, Ph.D., Chief Scientific Officer at Celera Diagnostics. “Too often, when new markers are reported, the disease association cannot be confirmed because the study used a small sample set. In addition, a spurious disease association could be found due to random chance alone if a large number of SNPs are tested. Alternatively, disease associations may not be confirmed in a second study because, in another sample set, different genes or mutations may cause the disease. For these reasons we replicated the results of our study with Dr. Kane in another large sample collection before announcing these findings.”
About Myocardial Infarction
Commonly known as a heart attack, a myocardial infarction occurs when a coronary artery is blocked, restricting blood flow to the heart. MI is a multi-factorial disease associated with both environmental and genetic factors. Some of the major risk factors associated with MI include high cholesterol, high blood pressure, diabetes, smoking and obesity. Although major risk factors are associated with the majority of MI events, it is difficult to predict individual outcomes based on these risk factors, and many people do not have symptoms of coronary disease before their first MI. This year an estimated 650,000 Americans will experience their first coronary attack, according to the American Heart Association. Approximately 7.6 million people in the United States age 20 and older have survived a heart attack.
About Celera Diagnostics and Applera Corporation
Celera Diagnostics is a 50/50 joint venture between two Applera Corporation businesses, Applied Biosystems and Celera Genomics. Headquartered in Alameda, CA, Celera Diagnostics focuses on discovering novel genetic markers for disease and configuring these into new diagnostic tests to predict, characterize, monitor and select therapy for cardiovascular disease, auto-immunity, central nervous system disorders, and cancer. The Celera Genomics Group, located in Rockville, MD, and South San Francisco, CA, is engaged principally in integrating advanced technologies to discover and develop new therapeutics. Celera intends to leverage its proteomics, bioinformatics, and genomics capabilities to identify and validate drug targets, and to discover and develop novel therapeutic candidates. Its Celera Discovery System™ online platform, marketed exclusively through the Applied Biosystems Knowledge Business, is an integrated source of information based on the human genome and other biological and medical sources. The Applied Biosystems Group develops and markets instrument-based systems, reagents, software, and contract services to the life science industry and research community. Customers use these tools to analyze nucleic acids (DNA and RNA), small molecules, and proteins to make scientific discoveries, develop new pharmaceuticals, and conduct standardized testing. Applied Biosystems is headquartered in Foster City, CA, and reported sales of $1.7 billion during fiscal 2003. Information about Applera Corporation, including reports and other information filed by the company with the Securities and Exchange Commission, is available at www.applera.com, or by telephoning 800.762.6923.
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," "expect," "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) uncertainty in obtaining intellectual property protection for inventions made by Celera Diagnostics; (2) unproven ability of Celera Diagnostics to discover, develop, and commercialize diagnostic products based findings from its disease association studies; (3) unproven use of genomics information to develop diagnostic products; (4) uncertainty as to whether Celera Diagnostics will be able to obtain any required regulatory approval of its diagnostic products; (5) uncertainty of market acceptance of the its products; (6) availability and pricing of certain raw materials and equipment; (7) the unproven ability of Celera Genomics to develop and commercialize therapeutics; and (8) 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.
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