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FDA Gives Nod to Abbott's RT-PCR HIV-1 Viral Load Test

NEW YORK (GenomeWeb News) - The US Food and Drug Administration has approved Abbott Laboratories' HIV-1 viral load prognostic test for use on its m2000 RT-PCR platform, Abbott and development partner Celera said on Friday.
 
The companies said the RealTime HIV-1 assay measures the levels of HIV circulating in a patient's bloodstream, including the three common HIV-1 groups and non-B subtypes. Abbott said the test is used for disease prognosis and to assess response to antiretroviral treatment.
 
Abbott developed the technology for its HIV-1 program through a research alliance with Celera, through which the companies develop nucleic acid-based diagnostic products.
 
"As the viral diversity of HIV-1 continues to increase, the need for highly sensitive tests to monitor patient response to antiviral therapies becomes even more important," said John Robinson, senior director of research and development at Abbott Molecular, in a statement.
 
The companies said the assay can measure HIV-1 in plasma "down to as few as 40 RNA molecules per milliliter, and up to as many as 10 million molecules per milliliter."
 
The m2000 system is made of two components; one that automates the extraction, purification, and preparation of DNA and RNA, and a PCR instrument that "amplifies, detects and measures minute levels of infectious agents," the companies said.
 
Abbott is also developing assays for hepatitis C virus, hepatitis B virus, HCV genotyping, chlamydia, and gonorrhea for the m2000.

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