Get your own Free Home PageNational Genetics Institute: 1-800-352-7788
Abbott Laboratories 's Viral Discovery Group: 847-937-2993
Specialty Lab: 1-800-421-4449
Nichols: 1-800-642-4657
Smith Kline: 1-800-366-8900
NATIONAL GENETICS INSTITUTE'S SUPERQUANT™ HCV ASSAY IS THE FIRST TEST TO DEMONSTRATE THE ANTIVIRAL EFFECTS OF A FDA APPROVED TREATMENT FOR CHRONIC HEPATITIS C INFECTION.
CULVER CITY, Calif., Oct. 9, 1997 /PRNewswire/ -- National Genetics Institute today announced that its quantitative assay (SUPERQUANT™ HCV) for measurement of the hepatitis C virus (HCV) has been recognized by the United States Food and Drug Administration (FDA) as an acceptable means to assess the efficacy of a newly approved drug for the treatment of chronic HCV infection. In a randomized controlled Phase III study of 704 chronic Hepatitis C patients treated with either INTRON®A (Schering Plough, Kenilworth, New Jersey) or INFERGEN® (Amgen Inc. Thousand Oaks, California), the SUPERQUANT™ HCV assay was used to assess changes in viral concentrations over the course of treatment and 6 months after stopping therapy. This represents the first time that the FDA has allowed product claims that include direct measurement of the antiviral effects of a treatment for chronic HCV infection.
The SUPERQUANT® HCV assay was developed using National Genetics Institute's proprietary robotic equipment and is able to reliably detect and quantify the HCV over a wide range of concentrations. "The measurement of HCV RNA by the highly sensitive SUPERQUANT™ HCV assay allowed us to accurately assess the antiviral effects of interferon therapy in patients with chronic Hepatitis C, and provides a valuable tool for the practicing physician," said Myron J. Tong, Ph.D., M.D, head of the liver center, Huntington Memorial Hospital (Pasadena, California), Professor of Medicine, University of Southern California and principle investigator for the INFERGEN®, Phase III study.
A recently issued report from the Consensus Development Conference on management of Hepatitis C held at the National Institute of Health stated that approximately four million Americans have chronic Hepatitis C infection. Additionally, the report estimated that between 8,000 to 10,000 people die each year in the United States as a result of complications of HCV infection. Finally, the report stated that proper monitoring of HCV infection should include use of a sensitive test to directly measure the HCV.
National Genetics Institute's SUPERQUANT™ HCV test has been commercially available since April, 1996 and is currently being used by over 3,000 clinicians in the United States to monitor over 20,000 patients infected with the Hepatitis C virus. In addition, the test is either currently in use or has been used in several randomized clinical studies that examine the antiviral effects of therapies for chronic Hepatitis C infection.
National Genetics Institute is a diagnostic laboratory that has developed proprietary technology for the elucidation and quantitation of nucleic acids. In addition to the SUPERQUANT™ HCV test, the laboratory currently offers testing services for HIV, HAV, HBV, HDV, HGV, HPV, CMV, PARVO/B19, SIV and specialized genotyping services. The laboratory in conjunction with its partner, the John Wayne Cancer Institute, is also currently developing nucleic acid based testing for determination of tumor metastasis for several cancers, including metastatic melanoma, breast cancer, prostate cancer, and gastrointestinal cancers.
ABBOTT SCIENTISTS DISCOVER NEW HEPATITIS VIRUS STRAIN
For the first time, genetically-distinct virus strain found in two U.S. residents
ABBOTT PARK, Ill., Nov. 13, 1997 /PRNewswire/ -- Researchers at Abbott Laboratories (NYSE: ABT) announced today the discovery of a new strain of the hepatitis E virus (HEV). The unique strain, referred to as HEV-US-1, was originally found in a patient nearly a year ago by Abbott Laboratories in collaboration with the Mayo Clinic. This discovery was recently confirmed by the identification of a second U.S. resident infected with the same strain of HEV.
Hepatitis E virus is a major contributor to fulminant hepatitis and liver failure in many developing nations. Infection with HEV is particularly devastating to pregnant women, resulting in death for 10-20 percent of women infected during their third trimester.
In 1995, a 62-year-old male, who had not traveled outside of the United States in 10 years, was hospitalized for developing acute hepatitis accompanied by fever, abdominal pain, jaundice and pruritis. Serological tests, manufactured by Abbott Laboratories, confirmed exposure to hepatitis E. Using molecular biology techniques, about two-thirds of the HEV genetic code was identified by Abbott scientists and found to be genetically different from the two major existing HEV strains.
For many years, scientists believed there were two major strains of HEV, including a Burmese (Asian) strain and a Mexican strain, so named by scientists who identified the strains in these regions. Cases of HEV have been reported in China, Mexico, Pakistan, India, Africa and Eastern Europe. Although cases of HEV are occasionally reported in the United States and Western Europe, the cases are usually associated with traveling to regions where HEV infections are common.
"This strain of HEV has never been identified in humans until the present time," said Isa K. Mushahwar, Ph.D., D.Sc., director of Abbott's Viral Discovery Group. "This unique case represents probably the first known report of acute hepatitis E that has not been linked to traveling outside the United States."
The original discovery has been recently validated by a second case of hepatitis E. Abbott researchers found the same unique strain of HEV-US-1 in the serum of a U.S. resident diagnosed with acute hepatitis in Memphis, Tenn. It's unclear if the virus was contracted in the United States or Mexico because the U.S. resident had recently traveled to Mexico.
"The recent discovery of the U.S. strain of HEV," added James Koziarz, Ph.D., vice president, diagnostic products research and development at Abbott Laboratories, "could represent an important clue in understanding the worldwide distribution of HEV and its role in human disease."
Currently, Abbott Laboratories manufactures a diagnostic test for HEV that is available in Europe, Asia and Latin America, but not in the United States. Research is ongoing to determine the clinical utility of this test in detecting the new U.S. strain.
In 1995, Abbott's Viral Discovery Group reported the discovery of three unique and distinct flaviviruses, now known as the GB viruses, A, B and C. The GB virus C has been shown to be transmitted by transfusion of blood and blood products, and has been the object of intensive studies over the last two years to determine its propensity to cause disease.
Abbott Laboratories is a global, diversified health care company devoted to the discovery, development, manufacture and marketing of pharmaceutical, diagnostic, nutritional and hospital products. The company employs 54,000 people and markets its products in more than 130 countries. In 1996, the company's sales and net earnings were $11.0 billion and $1.9 billion, respectively, with earnings per share of $2.41.
Abbott's news releases and other information are available on the company's web site at http://www.abbott.com.
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