VIDEO from Abbott and Synaptic Digital: Abbott Receives FDA Approval for Molecular Test for Hepatitis C
ABBOTT PARK, Ill., May 18, 2011 /PRNewswire/ -- Abbott announced today that it has received approval from the U.S. Food and Drug Administration to market its RealTime PCR (polymerase chain reaction) test for measuring the viral load of hepatitis C (HCV), the leading cause of liver cancer in the United States.
The Abbott RealTime HCV assay, developed for use on the Abbott m2000 system, is intended for use as an aid in the management of HCV-infected patients undergoing antiviral therapy. The assay measures HCV RNA levels at baseline and during treatment and can be utilized to predict sustained and non-sustained virological response to HCV therapy. The results from the RealTime HCV assay must be interpreted within the context of all relevant clinical and laboratory findings. The Abbott RealTime HCV assay is not for screening blood, plasma, serum or tissue donors for HCV, or to be used as a diagnostic test to confirm the presence of HCV infection.
See video from Abbott at: http://inr.synapticdigital.com/abbott/hepatitis/
"With the addition of the HCV assay to its automated m2000 system, Abbott is the only molecular diagnostics supplier in the U.S., to offer viral load assays for HIV, HBV and HCV, and a combination test for chlamydia and gonorrhea, on a single molecular platform," said Joseph Jacobs, M.D., associate medical director, Abbott Molecular. "This enables laboratories to consolidate sexually transmitted and infectious disease testing to improve workflow and productivity. Also, having a single manufacturer of these tests provides the clinician with a level of assurance of consistency and quality when managing patients."
The Abbott RealTime HCV test offers precise measurement (quantitation) of HCV in human plasma or serum. It is a highly sensitive HCV viral load test and the only one for which the limit of detection (lowest level of virus that generates a positive result) and the limit of quantitation (lowest exact viral load measurement) are the same, 12 IU/mL. This level of sensitivity enables clinicians to measure very low levels of the HCV virus to gauge success of antiviral drug treatment for eradicating the infection.
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SOURCE Synaptic Digital; Abbott