First U.S. Food and Drug Administration (FDA)-approved hepatitis C genotyping test is now available in the U.S. to help physicians improve patient care.
ABBOTT PARK, Ill., June 20, 2013 – Abbott announced today that it has introduced the first FDA-approved hepatitis C virus (HCV) genotyping test for patients in the United States. Abbott's fully automated RealTime HCV Genotype II test determines the specific type or strain (referred to as the genotype) of the HCV virus present in the blood of an HCV-infected individual. Genotyping the HCV virus provides physicians with important information they can use to create a personalized, targeted diagnosis and treatment path to improve clinical outcomes.
"Hepatitis C is known as the silent killer as many of the symptoms go unnoticed. When patients are identified, determining their specific genotype is important to ensuring they receive the treatment that will prove to be most effective. The introduction of this test for broad use in the U.S is a significant advancement in helping to address an important public health issue," said HIV and viral hepatitis expert, Carol Brosgart, M.D., Clinical Professor of Medicine, Division of Global Health, University of California San Francisco.
According to the Centers for Disease Control and Prevention (CDC), more than 75 percent of adults with hepatitis C are baby boomers — born between 1945 and 1965 — and most of them don’t know they are infected. In 2012, the CDC recommended that all baby boomers talk to their doctor and get a one-time test for HCV since this group is five times more likely to have the virus. Once a patient is diagnosed with HCV, a doctor would order a hepatitis C genotype test. The Abbott RealTime HCV Genotype II test is run on the fully automated m2000 platform, which provides laboratories substantial improvements in workflow efficiency to meet the increased demand.
"The Abbott RealTime HCV Genotype II test adds yet another test to the Abbott portfolio for a full spectrum of hepatitis C testing—from ensuring blood supply safety and providing initial screening to enabling targeted diagnoses, identification of the right treatments, and the monitoring of response to therapies," said John Coulter, vice president, Molecular Diagnostics, Abbott. "Abbott continues to expand diagnostic testing options in the infectious disease area to benefit the healthcare system and enable doctors to improve patient care."
About Hepatitis C
According to the U.S. Centers for Disease Control and Prevention, hepatitis C or HCV is primarily spread through contact with blood from an infected person. Common modes of transmission for these viruses include contaminated blood, intravenous drug use, transmission from parent to child, and sexual contact. Acute HCV infection is a short-term illness that occurs within the first six months after someone is exposed to the virus. However, for most people, acute infection leads to chronic infection, which is a serious disease that can result in long-term health problems or even death. Today, an estimated 3.2 million persons in the United States have chronic HCV infection.
About Abbott's Commitment to Hepatitis
With more than 40 years dedicated to developing and improving tests for detecting and monitoring the disease, Abbott has continued to focus on hepatitis public health issues in the United States and on a global basis. This includes developing one of the first commercial tests for detection of hepatitis B in 1972, followed by the introduction of a test for hepatitis A. Abbott also has had a long-standing global surveillance program to monitor the emergence of new viral strains.
About Abbott Molecular
Abbott Molecular is a leader in molecular diagnostics – the analysis of DNA and RNA at the molecular level. Abbott Molecular's tests can also detect subtle but key changes in patients' genes and chromosomes and have the potential to aid with early detection or diagnosis, can influence the selection of appropriate therapies, and may assist with monitoring of disease progression.
Abbott is a global healthcare company devoted to improving life through the development of products and technologies that span the breadth of healthcare. With a portfolio of leading, science-based offerings in diagnostics, medical devices, nutritionals and branded generic pharmaceuticals, Abbott serves people in more than 150 countries and employs approximately 70,000.
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