Navigation Links
Study Finds Noninvasive Blood Test for Liver Fibrosis May Alleviate Need for Liver Biopsies for Some Patients with Chronic Hepatitis C

MADISON, N.J., June 8 /PRNewswire-FirstCall/ -- A study in the June issue of Clinical Gastroenterology and Hepatology, published by Elsevier, demonstrates that the Hepascore(TM) liver fibrosis blood-serum test panel may help physicians more accurately diagnose and stage liver fibrosis in patients with chronic hepatitis C (HCV), potentially alleviating the need for liver biopsy, the standard of care for staging fibrosis, in a particular subset of patients. The Hepascore test panel is provided exclusively by Quest Diagnostics Incorporated (NYSE: DGX), the world's leading provider of diagnostic testing, information and services.

"Hepatologists have long sought a noninvasive technique for assessing fibrosis without conducting a liver biopsy, a painful procedure that can miss cirrhosis in some patients," said Nezam H. Afdhal, M.D., study investigator and director, Hepatology, Beth Israel Deaconess Medical Center and associate professor, Medicine, Harvard Medical School. "While Hepascore is unlikely to entirely replace liver biopsy as a staging test for liver fibrosis, one can envision an algorithm using Hepascore in the management of chronic HCV. In fact, the present study suggests that a unique Hepascore-based algorithm we developed that incorporates results of FIB-4 and APRI assessments would have spared 103 of the 391 study participants with chronic HCV the need for liver biopsy, with advanced fibrosis missed in one patient. We look forward to longitudinal studies that may prospectively assess the usefulness of Hepascore in clinical strategy for monitoring, treating and possibly alleviating the need for biopsy in a subset of chronic HCV patients."

Infection with HCV most often results in chronic HCV, a liver disease. An estimated 19,000 patients were infected with HCV in the U.S. in 2006 (Source: CDC). Chronic HCV is the most common cause of liver fibrosis, a condition that can progress to liver cirrhosis or cancer. Physicians manage HCV infection based on assessments of the degree of a patient's liver fibrosis. Although liver biopsy is the gold standard for determining the degree of fibrosis in chronic HCV patients, it can cause pain, bleeding and, in rare cases, death. Biopsy also must be performed repeatedly in order to monitor fibrosis' reversal or progression. In addition, an estimated 15 to 30 percent of biopsies miss cirrhosis. Physicians typically give antiviral drug therapy to patients with significant fibrosis and monitor chronic HCV patients at low risk of developing fibrosis.

In recent years, techniques have emerged that calculate a chronic HCV patient's likelihood for fibrosis based on assessments of levels of biomarkers found in blood specimens. Most of these techniques employ an algorithm that incorporates levels of nonspecific biomarkers as well as the patient's age and gender. The Hepascore method combines assessments of hyaluronic acid (HA), a biomarker specific to liver fibrosis, with assessments of the nonspecific biomarkers bilirubin, gamma-glutamyl transferase (GGT), alpha2 macroglobulin (A2M), and age and gender.

Previous studies of Hepascore in populations in France and Australia have showed it is reliable at predicting different degrees of fibrosis in chronic HCV patients. The objective of the present study was to validate the Hepascore test in a U.S. population with chronic HCV infection, and to compare it with two indices that employ nonspecific biomarkers, aspartate aminotranaminase (AST)-platelet ratio index (APRI) and Fibrosis-4 (FIB-4). Three hundred and ninety one patients with chronic HCV infection undergoing liver biopsy were enrolled from the Liver Center at Beth Israel Deaconess Medical Center in Boston. A reference range for a negative Hepascore was also determined from a study of 214 healthy volunteers. The diagnostic performance score for Hepascore by AUROC(1) was 0.81 for significant fibrosis, 0.83 for advanced fibrosis, and 0.88 for cirrhosis.

"While Hepascore is unlikely to entirely replace liver biopsy as a staging test for liver fibrosis, our findings demonstrate the potential value of a Hepascore-based algorithm in managing chronic HCV patients," said Wael A. Salameh, M.D., study investigator and medical director, endocrinology, Quest Diagnostics Nichols Institute. "For a Hepascore value less than or equal to 0.2, significant fibrosis is unlikely and continued observation on an annual basis is sufficient. For individuals with a Hepascore equal to or greater than 0.8 with elevated FIB-4 or APRI values, therapy and cancer screening should be strongly considered."

The study is titled "Validation of Hepascore, Compared With Simple Indices of Fibrosis, in Patients With Chronic Hepatitis C Virus Infection in United States." Beth Israel Deaconess Medical Center and Quest Diagnostics Nichols Institute, the esoteric research and development testing center of Quest Diagnostics, implemented the study. Quest Diagnostics funded the study. Dr. Afdhal is a consultant who has received grant support from Quest Diagnostics.

{Visit for more information on Clinical Gastroenterology and Hepatology, published by Elsevier. Members of the media may request copies of the publication by emailing Elsevier at}

Quest Diagnostics is a leader in noninvasive blood-based biomarker testing used by physicians to screen for, diagnose and monitor carcinomas and other tissue-based disease. The company's proprietary Leumeta(TM) portfolio of tests helps physicians identify and analyze genetic components of leukemia and lymphoma tumors using blood plasma instead of bone marrow, which can only be tested after extraction through painful biopsy. In addition, the company is the exclusive national reference laboratory provider of the blood-based HE4 Ovarian Cancer Monitoring test, which is FDA-cleared as an aid in monitoring epithelial ovarian cancer. The company is also developing a molecular blood test based on Epigenomics AG's Septin 9 DNA methylation biomarker that can help physicians detect colorectal cancer based on a patient's blood specimen.

About Quest Diagnostics

Quest Diagnostics is the world's leading provider of diagnostic testing, information and services that patients and doctors need to make better healthcare decisions. The company offers the broadest access to diagnostic testing services through its network of laboratories and patient service centers, and provides interpretive consultation through its extensive medical and scientific staff. Quest Diagnostics is a pioneer in developing innovative diagnostic tests and advanced healthcare information technology solutions that help improve patient care. Additional company information is available at

(1) AUROC is a graphic representation of test results that indicates a test's overall performance based on sensitivity and specificity, with a score up to 1.0. The closer a test scores to 1.0, the more accurate its performance.

SOURCE Quest Diagnostics Incorporated
Copyright©2009 PR Newswire.
All rights reserved

Related biology technology :

1. Dendreon Announces Publication of Phase 1 Study Highlighting Immunologic and Clinical Activity of Lapuleucel-T (Neuvenge(R)) in Advanced Breast Cancer Patients
2. Cephalon Announces Positive Results from a Pivotal Study of FENTORA in Opioid-tolerant Patients with Non-cancer Breakthrough Pain
3. Kline Study: Better Brushing Habits Boost European Oral Care Sales
4. Evotec to Present Details of the Positive Phase II Study in Insomnia With EVT 201 at the Worldsleep07 Congress in Cairns/Australia
5. NASA study will help stop stowaways to Mars
6. New Study Findings Confirm CLEXANE(R)/LOVENOX(R) Long-Term Clinical Benefit in Patients Suffering From Acute Coronary Syndrome
7. Study Published in Clinical Cancer Research Confirms Potential Of Peregrines Bavituximab Combined With Radiation In Lung Cancer
8. Evotec Reports Details of the Positive Proof-of-Concept Phase II Study in Insomnia With EVT 201
9. Study Supports Use of GlycoMark Blood Test to Evaluate Therapy in Children with Diabetes
10. Quigley Corporation Releases Update on Quigley Pharmas Phase IIb Clinical Study of QR-333 in Diabetic Peripheral Neuropathy
11. Biodel Inc. Announces VIAject(TM) Phase II Meal Study Data at the 2007 European Association for the Study of Diabetes Meeting
Post Your Comments:
(Date:11/25/2015)... --> ... 2020 report analyzes that automating biobanking workflow will ... long-term samples, minimizing manual errors, improving the workflow ... errors such as mislabeling or inaccurate sample barcoding ... a vital role in blood fractionation, DNA extraction, ...
(Date:11/25/2015)... 25, 2015  PharmAthene, Inc. (NYSE MKT: PIP) announced ... stockholder rights plan (Rights Plan) in an effort to ... (NOLs) under Section 382 of the Internal Revenue Code ... PharmAthene,s use of its NOLs could be substantially limited ... in Section 382 of the Code. In general, an ...
(Date:11/25/2015)... 2 nouvelles études permettent d , ... les souches bactériennes retrouvées dans la plaque dentaire ... . Ces recherches  ouvrent une nouvelle voie ... de l,un des problèmes de santé les plus ... --> 2 nouvelles études permettent d , ...
(Date:11/25/2015)... Studies reveal the differences in species of bacteria ... for more effective treatment for one of the most commonly ... --> --> Gum disease is one ... relatively little was understood about the bacteria associated with it ... researchers from the WALTHAM Centre for Pet Nutrition together with ...
Breaking Biology Technology:
(Date:10/29/2015)... JOLLA, Calif. , Oct. 29, 2015  The ... a new report titled, "DNA Synthesis and Biosecurity: Lessons ... well the Department of Health and Human Services guidance ... issued in 2010. --> ... but it also has the potential to pose unique ...
(Date:10/29/2015)... Oct. 29, 2015  Rubicon Genomics, Inc., today ... distribution of its DNA library preparation products, including ... new ThruPLEX Plasma-seq kit. ThruPLEX Plasma-seq has been ... of NGS libraries for liquid biopsies--the analysis of ... prognostic applications in cancer and other conditions. Eurofins ...
(Date:10/29/2015)... Connecticut , October 29, 2015 ... a biometric authentication company focused on the growing ... smart wallet announces that StackCommerce, a leading marketplace ... be featuring the Wocket® smart wallet on StackSocial ... NXTD ) ("NXT-ID" or the "Company"), a biometric ...
Breaking Biology News(10 mins):