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Specialty Laboratories Launches First Genomic Clinical Laboratory Test to Predict Progression to Liver Fibrosis for Hepatitis C Virus Patients

Posted on: Thursday, 5 October 2006, 09:00 CDT

Specialty Laboratories today announced the launch of HCV Liver Fibrosis GenotypR™, the first genomic clinical test to predict progression to liver fibrosis or cirrhosis for hepatitis C virus patients. This test identifies the patient's genomic signature of seven single nucleotide polymorphisms to provide a Cirrhosis Risk Score (CRS) which rates the relative risk of progression to liver fibrosis or cirrhosis. To assist physicians and patients in determining for whom early therapy is most warranted, the CRS places the patient into one of four risk groups.

Hepatitis C Virus (HCV) is a major cause of chronic liver disease with approximately 4 million people infected in the United States with 35,000 new infections identified annually. Liver biopsy is the primary method of establishing which patients to treat, based upon the amount of bridging fibrosis present at the time of the biopsy. Complications of chronic HCV infection, which are the leading indication for liver transplantation, are expected to result in large increases in medical care costs in coming decades as currently infected patients experience the long-term effects.

"With this assay physicians and patients will, for the first time, have the information they need to select the most appropriate course of therapy," said Robert M. Kisabeth, M.D., National Esoteric Medical Director for Specialty Laboratories. The HCV Liver Fibrosis GenotypR™ can identify which HCV patients are at low risk of progression to fibrosis as well as those with up to a 4-fold increased risk.

"Specialty Laboratories is pleased to continue its tradition of industry leadership in offering new clinically relevant testing with the launch of the HCV Liver Fibrosis GenotypR™," said Keith Laughman, President of Specialty Laboratories. Specialty Laboratories has developed this test under an intellectual property license from the Celera Genomics Group of Applera Corporation of Rockville, MD.

About Specialty Laboratories, Inc.

Specialty Laboratories is a leading provider of highly advanced clinical tests used by physicians to diagnose, monitor and treat disease and is a single-source solution for esoteric testing needs nationwide. Specialty supports local pathology and community-based medicine by partnering with pathologists and hospitals to improve patient care and reduce episodes-of-care costs. Specialty is the esoteric testing division of AmeriPath, a leading national provider of physician-based anatomic pathology, dermatopathology and molecular diagnostic services to physicians, hospitals, clinical laboratories and surgery centers, and supports community-based medicine by helping physicians provide excellent and effective care for their patients.

For more information visit Specialty's Web Site at www.specialtylabs.com.

Source: Business Wire

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