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Celera Diagnostics Identifies Novel Genetic Markers Linked to Increased Risk of Heart Attack
Discoveries Published in the American Journal of Human Genetics - Expanded Understanding of Disease Biology Creates Diagnostic Opportunities

Alameda, CA - August 29, 2005

Scientists from Celera Diagnostics today published novel findings linking genetic variations in four genes with an increased risk for myocardial infarction (MI), or heart attack. None of these gene variants have previously been associated with MI, and they could lead to the identification of new coronary heart disease (CHD) mechanisms. This paper will appear in the October 2005 edition of the American Journal of Human Genetics, and is currently available on the publication’s website at http://www.journals.uchicago.edu/AJHG/home.html. Celera Diagnostics, a joint venture between the Applied Biosystems Group (NYSE:ABI) and Celera Genomics Group (NYSE:CRA) of Applera Corporation, conducted the study in collaboration with researchers at Quest Diagnostics (NYSE:DGX), the Cleveland Clinic Foundation and the University of California, San Francisco.

These findings are the latest in a series of communications regarding MI and other cardiovascular disease-related discoveries made by Celera Diagnostics and its collaborators, as well as discoveries toward understanding the genetic basis for individuals who derive increased benefit from statin therapy in preventing MI. Celera Diagnostics has completed association studies in several cardiovascular diseases and the pharmacogenomics of treatment for cardiovascular diseases, and has additional studies with data from more than 30,000 subjects.

“This study, coupled with other prospective studies underway at Celera Diagnostics, is providing valuable insight toward the ongoing development of a ‘Genetic Risk Score’ that is expected to identify individuals at elevated risk for MI,” said Kathy Ordoñez, President of Celera Diagnostics. “More than 17 million people in the United States fall into the category of moderate risk for having a heart attack using existing methods of evaluation, such as measuring serum cholesterol, blood pressure, and assessing the genetic component through taking a family history. A ‘Genetic Risk Score’ will not only enable physicians to make a quantitative estimate of each individual’s relative genetic risk for MI, but importantly it will also identify those individuals who would otherwise not have been considered at risk for MI, and who could benefit from preventive treatment.”

“We are in the process of translating these findings into clinical practice and moving toward the commercialization of these exciting discoveries,” Ms Ordoñez added. “We continue to work closely with our clinical laboratory collaborators on prospective studies of the general population to identify the most informative constellation of diagnostic markers associated with MI and increased statin benefit, and anticipate communicating these as they are published over the coming months.”

“Multiple large scale studies for discovery, with well-characterized DNA samples from carefully selected patients and matched controls, hold significant promise to discover new gene variants that predict risk for MI and will enable the development of new diagnostics,” said Ray Fenwick, Ph.D., Scientific Director, Molecular Endocrinology at Quest Diagnostics Nichols Institute, and a co-author of the paper. “In addition, the replication of our results in two additional case-control studies confirms the significance of these results in identifying individuals at increased risk for heart attack even when standard risk factors such as smoking and obesity are taken into account.”

Summary of Scientific Findings
Celera Diagnostics evaluated DNA samples from more than 3,000 individuals in three studies to compare patterns of genetic variation in people with a history of MI to those with no history of CHD. The results were replicated in all three studies.

This study found that variants in four genes were associated with MI in three studies. These gene variants encode the cytoskeletal protein palladin, a tyrosine kinase, and two G protein-coupled receptors. Each of these gene variants individually confers an increased risk for MI that is comparable to conventional risk factors such as smoking, high blood pressure and elevated cholesterol levels.

These genetic markers were identified through a genome-wide study of initial 11,053 single nucleotide polymorphisms (SNPs) in 6,891 genes of a broader scan, focusing on SNPs that could influence gene function in order to increase the likelihood of identifying disease-causing gene variants. To minimize false positive associations generated by multiple testing, two studies were used to identify a limited number of nominally associated SNPs; a third study tested the hypotheses that these SNPs are associated with MI.

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 700,000 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.

Prevention of MI is focused on management of risk factors. Recommended lifestyle changes include quitting smoking, exercising and following a healthy diet. Over 40 million people worldwide take lipid-lowering drugs (statins) and studies have shown that statins can significantly reduce risk for coronary heart disease (CHD). Yet, less than half of the people who qualify for any kind of lipid-modifying treatment for CHD risk are receiving it, the American Heart Association reports in its Heart Disease & Stroke Statistics – 2005 Update.

Celera Diagnostics’ Discovery Research Approach
Celera Diagnostics compares genotype and/or gene expression profiles in samples from healthy and affected individuals to associate genetic and genomic 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 multiple common, complex diseases, including four forms of cardiovascular disease, breast cancer, rheumatoid arthritis, psoriasis, Alzheimer’s disease, liver disease, and a metabolic disease. The pharmacogenomic studies include statin therapy and interferon responsiveness for HCV infection.

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 of these associated markers may also be drug targets, which are being evaluated by Celera Genomics, possibly in partnership with other collaborators.

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 developing new molecular and protein-based diagnostic tests to predict, characterize, monitor and select therapy for a variety of clinical conditions. The Celera Genomics Group, located in Rockville, MD, and South San Francisco, CA, is leveraging its proteomic, bioinformatic, and genomic capabilities to identify and validate drug targets, and to discover and develop small molecule therapeutics. It is also seeking to advance therapeutic antibody and selected small molecule drug programs in collaboration with global technology and market leaders. The Applied Biosystems Group 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, develop new pharmaceuticals, and conduct standardized testing. Applied Biosystems is headquartered in Foster City, CA, and reported sales of nearly $1.8 billion during fiscal 2005. 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.

Copyright© 2005. Applera Corporation. All rights reserved. Applied Biosystems is a registered trademark and Applera, Celera, Celera Diagnostics, Celera Genomics, Celera Discovery System and ViroSeq are trademarks of Applera Corporation or its subsidiaries in the US and certain other countries.

Contact:

Celera:
David Speechly, Ph.D.
tel.: 510.749.1853
email: david.speechly@celera.com

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