PipelineReview.com - Biotech News & Online Store - Celera Announces Data Supporting a Predictor for Risk of Cirrhosis in Chronic Hepatitis C Patients; Research Studies Involving 1,500 Patient Samples from Multiple Institutions Show Clinical Utility of Cirrhosis Risk Score (tm)

Celera Announces Data Supporting a Predictor for Risk of Cirrhosis in Chronic Hepatitis C Patients; Research Studies Involving 1,500 Patient Samples from Multiple Institutions Show Clinical Utility of Cirrhosis Risk Score (tm)

27 Apr 2006

ROCKVILLE, MD, USA and VIENNA, Austria | Apr 26, 2006 | Cirrhosis Risk Score May Guide Treatment and Reduce the Need for

Liver Biopsies Celera Genomics (NYSE:CRA), an Applera Corporation business, today announced the presentation of data supporting a multi-gene Genetic Risk Score that predicts future risk of developing cirrhosis in patients with chronic hepatitis C (CHC). The presentation will be made on April 28, 2006 at the 41st annual meeting of The European Association for the Study of the Liver, in Vienna, Austria.

The data presented supports a constellation of seven single nucleotide polymorphisms (SNPs) that predicts the risk of cirrhosis in patients with CHC, and is a significantly better predictor than present clinical risk factors for the disease.

The use of a combination of SNPs as a prognostic tool suggests information will be applicable to a larger fraction of HCV-infected individuals, will likely prove more robust across risk groups tested, and have more compelling use for patient management than current methodologies.

The 7 SNPs were identified and validated through multiple research studies conducted over three years involving approximately 1,500 individuals infected with CHC, whose samples were tested for the presence of approximately 25,000 SNPs as part of a Celera functional genome scan. SNPs identified as associated with risk for cirrhosis through initial association studies that survived replication by testing with additional samples were used to develop a training algorithm to select the optimal constellation of 7 SNPs. These 7 SNPs were finally tested in another set of samples to confirm their performance in predicting risk for cirrhosis.

The results, which will be presented by Hongjin Huang, Ph.D., Manager, Liver Diseases at Celera, in the general session on Friday, April 28, 2006, indicate that this combination of 7 SNPs is a better predictor than clinical risk factors, such as age, gender and daily alcohol consumption. In the clinical validation sample set of 448 research subjects, the area under the ROC (receiver operator characteristic) curve (AUC) was 0.73 (p=0.0035) using this combination of 7 SNPs, versus 0.53 (p=0.36) using clinical risk factors alone. When this Cirrhosis Risk Score(TM) was combined with clinical risk factors, the AUC was 0.76 (p=0.0006). Individuals with a high Cirrhosis Risk Score and clinical risk factors were shown to have greater than 8-fold risk of developing cirrhosis.

The source of SNPs for building the signature was derived from two initial studies: a discovery study involving 537 CHC research subjects that was performed with collaborators at the University of California in San Francisco; and a replication study involving 483 research subjects with collaborators at Virginia Commonwealth University. The resulting Celera 7 SNP combination was independently tested on 448 research subjects enrolled in a study at Stanford University, University of Illinois Chicago and California Pacific Medical Center. This clinical validation sample set was not involved in selecting SNPs or in building the CRS.

"This study confirms that the genetic makeup of each patient is the most important factor in determining which patients with chronic HCV are likely to develop fibrosis progression to cirrhosis," said Mitchell L. Shiffman, M.D., Professor of Medicine, Chief, Hepatology, Medical Director, Liver Transplant Program, Virginia Commonwealth University Medical Center, and a collaborator and co-author of the study. "These data are very likely to change the way in which we evaluate and select patients for anti-viral therapy."

"Use of this information to select and treat the patients at highest risk for progression earlier may help prevent irreversible liver damage and improve patient compliance with therapy," said Kathy Ordonez, President of Celera Genomics. "These results may also enable more cost-effective and timely demonstration of efficacy for new drug therapies by enriching trials with those individuals more likely to suffer from disease progression."

Celera is currently pursuing this program independently, outside its strategic alliance with Abbott.

About Cirrhosis and Hepatitis C infection

Hepatitis C virus is a very serious medical problem in the United States and throughout the world. Almost four million Americans are infected with the hepatitis C virus, of whom 2.7 million have chronic infection. If undetected and untreated, hepatitis C infections can lead to chronic liver disease, including liver fibrosis, leading to cirrhosis and liver cancer. Hepatitis C infections are the second leading cause of liver cirrhosis and the leading indication for liver transplantation in the United States.(1)

Projections based on the current prevalence of infection and anticipated rates of progression raise concerns over the potential impact of HCV during the next 2 decades. A computer cohort simulation of the US population for 2010-2019 suggests that the morbidity and mortality associated with CHC will increase dramatically, resulting in 165,900 deaths from chronic liver disease, 27,200 deaths from hepatocellular carcinoma (HCC), and $10.7 billion in direct medical expenditures related to HCV.(2)

For more information on the management of Hepatitis C patients, see for example

About Applera Corporation and Celera Genomics

Applera Corporation consists of two operating groups. The Celera Genomics Group uses proprietary genomics and proteomics discovery platforms to develop molecular diagnostic products and to identify and validate novel drug targets. Celera maintains a profit-sharing strategic alliance in molecular diagnostics with Abbott. In addition, Celera is developing new molecular diagnostic and pharmacogenomic assays outside of its alliance with Abbott. Therapeutic antibodies against Celera-discovered drug targets are being advanced through strategic partnerships. 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 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, for example in food and the environment. 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 http://www.applera.com, or by telephoning 800.762.6923. Information about Celera Genomics is available at http://www.celera.com.

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) Celera's unproven ability to discover, develop, or commercialize proprietary diagnostic products; (2) 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; (3) 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; (4) legal, ethical, and social issues which could affect demand for Celera's products; and (5) 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(C) 2006. Applera Corporation. All rights reserved. Applied Biosystems is a registered trademark and Applera, Celera, and Celera Genomics are trademarks of Applera Corporation or its subsidiaries in the US and/or certain other countries.

(1) http://www.cdc.gov/

(2) AGA Technical review on the management of Hepatitis C (2006). Gastroenterology. 130: 231-264.

CONTACT: Celera Genomics Group
David Speechly, Ph.D., 510-749-1853
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SOURCE: Celera Genomics Group

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