Celera Publishes Proprietary Genetic Assay
as Predictor of Cirrhosis in Chronic HCV
[Although the PR does not mention it, this tool could presumably be used to balance trial arms in randomized, controlled studies of HCV therapies.]
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Friday April 27, 12:01 am ET
Cirrhosis Risk Score Outperforms Current Clinical Factors in Predicting Risk of Liver Disease
Cirrhosis Risk Score Adds a New Dimension in Optimizing Patient Care, Guides Urgency of Anti-Viral Treatment and May Reduce the Need for Liver Biopsies
ROCKVILLE, Md.--(BUSINESS WIRE)--Celera (NYSE: CRA ), an Applera Corporation business, today announced the publication of data from a research study validating its multi-gene Cirrhosis Risk Score (CRS) that predicts future risk of developing cirrhosis in patients with chronic hepatitis C (CHC). This paper is scheduled to appear in the August 2007 edition of Hepatology, published on behalf of the American Association for the Study of Liver Diseases, and is expected to be available on the publication's website at www3.interscience.wiley.com/cgi-bin/jhome/106570044. The lead author of this paper was Hongjin Huang, Ph.D., Associate Director, Liver Diseases, at Celera.
This research study demonstrates that a constellation of seven single nucleotide polymorphisms (SNPs) predicts the risk of cirrhosis in Caucasian patients with CHC, and may be a significantly better predictor than some of the presently known clinical risk factors, such as age, gender and alcohol consumption, in differentiating high risk versus low risk for cirrhosis.
"The Cirrhosis Risk Score offers a real opportunity to change the way in which we evaluate and select patients for anti-viral therapy," said Ramsey C. Cheung, M.D., Associate Professor of Medicine, Division of Gastroenterology and Hepatology at Stanford University, and co-author on this paper. "It fills an unmet need to stratify actual cirrhosis risk to determine the urgency of anti-viral therapy without using liver biopsy as a surrogate marker. Use of this information to select and treat the patients at higher risk for progression earlier may help prevent irreversible liver damage and improve cost-effectiveness. Patients will also benefit from knowing their risk."
"This study confirms that the genetic makeup of each patient is a critical factor in determining who is likely to develop cirrhosis," said Thomas J. White, Ph.D., Chief Scientific Officer at Celera, and a co-author on the paper. "These results may also enable more cost-effective and timely demonstration of the efficacy for antifibrotic therapies by enriching clinical trials with those individuals likely to progress more rapidly to cirrhosis."
The seven SNPs were identified and validated through multiple research studies conducted over five years involving 1,020 individuals infected with HCV, whose samples were tested for the presence of approximately 25,000 SNPs as part of a functional genome scan. SNPs identified as associated with risk for cirrhosis through initial studies, and that survived replication by testing with additional samples, were used to select the optimal combination of seven SNPs. A Cirrhosis Risk Score was calculated based on the seven-SNP constellation to estimate the risk of developing cirrhosis for each patient.
The source of SNPs for building the signature was derived from two initial research studies: a discovery study involving 537 subjects that was performed with collaborators at the University of California in San Francisco, and a replication study involving 483 subjects with collaborators at Virginia Commonwealth University. The resulting constellation was independently tested on 448 CHC subjects enrolled in studies at Stanford University, University of Illinois Chicago and California Pacific Medical Center. This validation sample set was not involved in selecting the SNPs or in building the CRS.
"This publication underscores the potential clinical value of Celera's genetic discoveries," said Kathy Ordonez, President of Celera. "The genetic markers described in this paper have been licensed on a non-exclusive basis to Specialty Laboratories, which has developed, validated and commercialized a testing service, HCV Liver Fibrosis GenotypR(TM), incorporating these findings. Celera also intends to seek review of an in vitro diagnostic product based on the CRS with the U.S. Food and Drug Administration and other applicable global regulatory agencies."
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 and 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.
Projections based on the current prevalence of infection and anticipated rates of progression raise concerns over the impact of HCV in 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 by 2019.
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