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Abbott Receives Supplemental FDA Approval for its Best-in-Class in Sensitivity RealTime HIV-1 Viral Load Test
Date:8/19/2007

New Design Features Give Molecular Laboratories Increased Efficiencies and

Flexibility for Abbott's HIV-1 Viral Load Test, Which Surpasses Standard-of-Care Sensitivity and is Unique in its Ability to Detect and

Measure All Known Strains of HIV-1

DES PLAINES, Ill., Aug. 9 /PRNewswire-FirstCall/ -- Abbott (NYSE: ABT) 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(TM) 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
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SOURCE Abbott

Copyright©2007 PR Newswire.

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