Abbott Receives Supplemental FDA Approval for its RealTime HIV-1 Viral Load Test
News Aug 13, 2007
Abbott has received a supplemental Premarket Approval from the U.S. Food and Drug Administration for its recently introduced RealTime HIV-1 viral load test.
The approval allows Abbott to market a number of enhancements to the test, including a new design feature that will give laboratories the flexibility to perform HIV-1 viral load tests with smaller amounts (0.6 mL) of blood plasma. Abbott markets the m2000™ system and a menu of tests throughout the world as part of a strategic alliance with Celera.
"It can be challenging to obtain blood samples from some people, particularly critically ill patients," said Timothy Stenzel, M.D., Ph.D., medical director, Abbott Molecular. "This improvement will give labs the ability to use a smaller sample size while still maintaining the highest sensitivity and precision of any HIV-1 viral load test. It’s easier on the patient and at the same time better for the lab."
Initially approved in the United States on May 11, 2007, the RealTime test, based on real-time polymerase chain reaction (PCR) technology, is the most sensitive HIV-1 viral load test available and the only test of its kind validated to detect and quantitate (precisely measure) the common strains of HIV-1 as well as all known genetic variations of the virus, including group O, group N, and non-B subtypes.
The Abbott assay has a broad dynamic range, capable of quantitating HIV-1 in plasma down to as few as 40 RNA copies per mL, surpassing the standard of care in diagnostic sensitivity of 50 copies per mL.
Also, unlike other assays, the Abbott RealTime HIV-1 test targets the highly conserved pol integrase region of the HIV-1 genome, giving the test its unique ability to detect and measure all known genetic variations of the virus.
The company also received supplemental approval to increase the testing capacity of the Abbott m2000 automated instrument for use with the RealTime HIV-1 viral load test. The enhanced system can process up to 96 specimens in a batch and 192 specimens in one laboratory shift. This represents the highest throughput available for an HIV-1 viral load test using real-time PCR technology.
"We’re pleased to offer these important enhancements, which we believe reinforces the clinical advantages of the RealTime HIV-1 viral load test," said Stafford O’Kelly, president, Abbott Molecular.