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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

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.

"Because of what we now know about the emergence of variant strains of HIV-1 in the United States and other countries, it is critical for clinicians to monitor for non-B subtypes as well as group O and group N strains of HIV-1 in their patients," Stenzel said. "It is imperative that an assay with reliable subtype performance be used to guide antiretroviral therapy so as to not be lulled into thinking a patient is responding well to therapy when, in fact, they are not. The RealTime assay also correlates well with other viral load tests, which suggests that it is not necessary for physicians to reestablish a baseline viral load for their patients when changing to this test," he said.

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.

Additional products in development in the United States for the Abbott m2000 system include assays for hepatitis C virus, hepatitis B virus, chlamydia and gonorrhea. The m2000 system and a full menu of infectious disease tests are available in the European Union as CE-marked products.

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