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May 22, 2011

Abbott HCV Test Receives FDA Approval

Abbott has received US Food and Drug Administration (FDA) approval to market its real-time polymerase chain reaction test, which is used to measure the viral load of hepatitis C (HCV), the leading cause of liver cancer. The Abbott RealTime HCV assay, developed for use on the Abbott m200

By cms admin

Abbott has received US Food and Drug Administration (FDA) approval to market its real-time polymerase chain reaction test, which is used to measure the viral load of hepatitis C (HCV), the leading cause of liver cancer.

The Abbott RealTime HCV assay, developed for use on the Abbott m2000 system, is used as an aid in the management of HCV-infected patients undergoing antiviral therapy.

The assay measures HCV RNA levels, which can be used to predict sustained and non-sustained virological responses to HCV therapy.

Abbott Molecular associate medical director Joseph Jacobs said that, with the addition of the HCV assay to its automated m2000 system, Abbott is the only molecular diagnostics supplier in the US to offer viral load assays for HIV, HBV, HCV and a combination test for chlamydia and gonorrhoea on a single molecular platform.

“This enables laboratories to consolidate sexually transmitted and infectious disease testing to improve workflow and productivity, and also provides the clinician with a level of assurance of consistency and quality when managing patients,” said Jacobs.

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