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FDA approves first genotyping test for patients with hepatitis C virus
  The U.S. Food and Drug Administration today approved a test that identifies the genotypeof hepatitis C virus (HCV) that apatientis carrying. The Abbott RealTime HCV Genotype II, which can differentiate genotypes 1, 1a, 1b, 2, 3, 4, and 5,using a sample of an infected patient's blood plasma or serum, will aid health care professionals in determining the appropriate approach to treatment.
Because the various HCV genotypes respond differently to available drug therapies, knowing the type of HCV a person is infected with can result in better patient outcomes.
"Tests such as this one can help physicians gain an understanding of a patient's HCV status," said Alberto Gutierrez, Ph.D., director of the Office of In Vitro Diagnostics and Radiological Health in FDA's Center for Devices and Radiological Health. "Along with other clinical factors, the particular type of HCV is an important consideration in aiding health care professionals in determining if and when to initiate treatment and the appropriate type of treatment."
According to the Centers for Disease Control and Prevention, HCV is the most common chronic blood-borne infection in the United States and the leading cause of liver transplants. About 3.2 million people in the United States have a chronic HCV infection and approximately 15,000 people die from the effects of the virus each year. Seventy-five to 85 percent of people infected with HCV are not able to fight off the virus on their own and develop a chronic HCV infection that requires treatment. Untreated chronic HCV infections may lead to liver cancer, severe liver damage and liver failure.
HCV is transmitted through blood and other bodily fluids. Injection drug users who share needles are at the highest risk for HCV infection. Health care workers stuck by needles that have been used on HCV-infected patients and children born to HCV-infected mothers are also at risk.
The Abbott RealTime HCV Genotype II is approved for individuals known to be chronically infected with HCV. It is not approved for use as a diagnostic test or as a screening test for the presence of HCV genetic material in blood, blood products or tissue donors. It has not been evaluated in newborns or pediatric patients, or in patients with compromised immune systems, such as people with AIDS.
The FDA based its approval of the Abbott RealTime HCV Genotype II, in part, on the assessment of the test's accuracy in differentiating specific HCV viral genotypes compared to a validated genesequencing method. The FDA also reviewed data from investigators demonstrating the relationship between HCV genotype and effectiveness of drug therapy.
The Abbott RealTime HCV Genotype II test is manufactured by Abbott Molecular Inc., in Des Plaines, Ill.
Press Release
Abbott Announces New Test to Help Doctors Determine Personalized Treatment Path for Patients with Hepatitis C
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.
June 20, 2013
Abbott Park, Illinois - 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.
About Abbott
Abbott (NYSE: ABT) 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.
Visit Abbott at www.abbott.com and connect with us on Twitter at @AbbottNews.
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