Abbott RealTime PCR assay for measuring HCV viral load receives FDA marketing approval

Abbott (NYSE: ABT) 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.

"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.

"Monitoring HCV RNA levels is important in the management of the disease with antiviral medications such as interferon and ribavirin," said Paul Martin, M.D., a gastroenterologist and hepatitis researcher with the Schiff Liver Institute and Center for Liver Diseases in Miami, and clinical investigator and consultant for Abbott. "Viral load measurements help physicians determine whether to begin antiviral therapy, influence decisions on dosing and therapy duration, and identify drug resistant strains."

"The Abbott RealTime HCV assay detects and measures the six most common HCV genotypes by targeting an essential, highly conserved segment of the viral genome," said Stafford O'Kelly, head of Abbott's molecular diagnostics business. "It is a highly sensitive molecular assay and offers complete coverage of all HCV genotypes, as demonstrated in peer reviewed publications."  

A study published in the June 2009 edition of the Journal of Clinical Microbiology (Chevaliez, Bouvier-Alias and Pawlotski) concluded that "the Abbott m2000 RealTime PCR system for HCV RNA quantification is sensitive, specific and precise; that the results are reproducible; and that the platform's broad dynamic range of quantification is well suited to HCV RNA monitoring in the clinical setting."

In addition to its HCV in vitro diagnostic products, Abbott currently has four investigational pharmaceutical compounds in phase 2 clinical trials for the treatment of HCV, including a protease inhibitor, two polymerase inhibitors and an NS5A inhibitor.