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Roche Receives FDA Approval for Viral Load Test Designed to Evaluate Hepatitis C Therapy

14 Mar 2013

Product news

Roche announced today that it has received approval from the US Food and Drug Administration (FDA) for a next-generation viral load test to be used in the management of patients with chronic hepatitis C virus (HCV) infection, which affects 200 million people globally. The COBAS AmpliPrep/COBAS TaqMan HCV Test, v2.0 provides a novel dual-probe approach, for an extra layer of protection in detecting and quantifying the virus. The test is designed to accurately determine the amount of hepatitis C virus ribonucleic acid (RNA) in order to assess a patient’s response to antiviral therapy.

“The rapidly changing hepatitis C treatment landscape requires tests with an additional layer of protection in detecting and accurately quantifying hepatitis C RNA across genotypes,” stated Roland Diggelmann, Chief Operating Officer of Roche’s Diagnostics Division. “This test can play a valuable role in response-guided therapy, helping physicians and patients better manage the disease and optimize treatment choices and duration.”

Furthermore, Roche tests have been used in the development of recently FDA-approved direct-acting antiviral treatment regimens. With this launch Roche Molecular Diagnostics continues its long heritage of providing innovative viral load testing solutions for establishing treatment efficacy for new therapeutic regimens.
The new HCV viral load test is part of Roche’s complete portfolio of diagnostic tests to diagnose, confirm and manage hepatitis C infection. Roche expects to begin shipping the new HCV viral load test kit in the US shortly.

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ImmunologyImmunological techniques measure and characterize immune responses. Immunology kits and analysis systems often use techniques such as ELISA, radioimmunoassay (RIA) and immunodiffusion assays, Immunohistochemistry, and flow cytometry. Immunologists use equipment such as flow Cytometers, plate readers, plate washers and fluorescent microscopes.Clinical GeneticsMolecular Genetics covers the analysis of hereditary genetic disease and chromosomal abnormalities. Genetics can be analysed using DNA, RNA, and protein microarrays, PCR, RT PCR and DNA sequencing. Genetic equipment includes genetic workstations, thermal cyclers, cooling blocks and electrophoresis products. Diagnostic kits are used for DNA / RNA extraction and purification.HepatitisFDAThe Food and Drug Association (FDA) is an agency within the U.S. Department of Health and Human Services. Among other things, it is responsible for ensuring the safety, effectiveness and quality of drugs, vaccines and other biological products, and medical devices. RNARNA is a nucleic acid that plays a key role in gene expression and protein synthesis. It serves as a messenger between DNA and ribosomes, carrying genetic instructions to produce proteins. Advances in RNA-based therapies, such as mRNA vaccines and gene editing, have revolutionized treatment strategies for genetic disorders and infectious diseases. Explore RNA research tools and therapies in our peer-reviewed product directory; compare products, check customer reviews, and get pricing directly from manufacturers.

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