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Abbott's PCR-based HCV Test Cleared by FDA

By a GenomeWeb staff reporter

NEW YORK (GenomeWeb News) – Abbott today announced the US Food and Drug Administration has approved its RealTime PCR-based test for hepatitis C.

The test, which runs on the Abbott m2000 platform, measures HCV in human plasma or serum. According to Abbott, it is the only test for which the limit of detection and limit of quantitation are the same, 12 IU/mL. At this level of sensitivity, physicians can measure very low levels of the virus in order to determine whether antiviral drug treatments are working, the company added.

In a statement, Joseph Jacobs, associate medical director for Abbott, said that the addition of the HCV assay to the m2000 system makes Abbott the only molecular diagnostic company in the US offering viral load assays for HIV, HBV, and HCV, and a combination test for chlamydia and gonorrhea on one platform.

"This enables laboratories to consolidate sexually transmitted and infectious disease testing to improve workflow and productivity," Jacobs said. "Also, having a single manufacturer of these tests provides the clinician with a level of assurance of consistency and quality when managing patients."

The RealTime HCV assay is used to help manage HCV-infected patients undergoing antiviral therapy. It measures HCV RNA levels at baseline and during treatment, and can be used to predict sustained and non-sustained virological response to HCV therapy, Abbott said.

Test results must be interpreted "within the context of all relevant clinical and laboratory findings," it said, adding the test is not for screening blood, plasma, serum, or tissue donors for HCV. It also is not for use as a diagnostic for the presence of the virus.

In addition to Abbott, several other firms are developing a molecular diagnostic test for HCV, and last fall Roche received FDA clearance for its second-generation real-time PCR Cobas TaqMan HCV test. Siemens Healthcare received FDA clearance for an HCV monitoring test in 2008.

Also in the fall, Abbott and Qiagen entered into a broad-based molecular diagnostics agreement, and as part of the deal, Abbott is providing a quantitative HCV test, to be optimized and labeled for use on Qiagen's QIAsymphony RGQ instrument. The test, which is anticipated to launch at the end of 2012, will be marketed under the Abbott name in the US and Canada.

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