FDA approves Roche’s qualitative Amplicor HCV Test
First approved PCR-based test to detect Hepatitis C Virus
The U.S. food and Drug Administration (FDA) has granted marketing approval for Roche’s two hepatitis C tests designed to directly detect the presence of the Hepatitis C virus (HCV) in the blood. Roche’s Amplicor HCV Test (version 2.0) and Cobas Amplicor HCV Test (version 2.0) are the first qualitative Hepatitis C tests based on RNA (ribonucleic acid) to be approved for marketing by the FDA. The FDA granted Roche expedited review for both tests in April 2000.
The Amplicor HCV Tests detect the presence of RNA in serum; a positive result indicates current infection. The tests are the first – and only – commercial qualitative nucleic acid tests available through hospitals and licensed laboratories. The Amplicor HCV Tests are indicated for patients who have liver disease and antibodies to HCV and who are suspected to have active HCV infection. The presence of RNA as detected by these qualitative tests is evidence of active HCV infection but does not distinguish between acute and chronic states of infection.
“FDA’s decision to give priority review status for the two applications indicates the seriousness of the Hepatitis C epidemic,” said Heino von Prondzynski, Head of Roche Diagnostics. “Using these sensitive, accurate tests, physicians can identify infection more efficiently and thereby begin appropriate treatment sooner. Roche is committed to developing the most advanced technologies for better treatment and testing options for the millions of people affected by this epidemic.”
Roche’s Amplicor HCV Tests utilize Noble Prize-winning Polymerase Chain Reaction (PCR) technology to directly detect the Hepatitis C viral RNA. In addition, the Amplicor HCV Tests are the first HCV RNA assays to report the analytical sensitivity in International Units (IU/mL), as defined by the WHO International Standard for HCV RNA for Nucleic Acid Amplification Technology (NAT) Assays.
Hepatitis C is a viral infection that attacks the liver, and is increasingly recognized as a major cause of liver disease, liver failure and death. 3% of the world population is believed to be infected with HCV. HCV is more common and more infectious than HIV, and there are 180,000 new cases occurring each year. In its early stages the disease is asymptomatic, therefore many people are not aware that they are infected until they begin to suffer from liver malfunction, which can lead to liver failure. Hepatitis C is transmitted through body fluids, primarily blood or blood products, and sharing needles. In many patients, the mode of transmission is unknown.
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