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Roche Receives FDA Approval for HIV-1/HIV-2 Qualitative Molecular Test

NEW YORK ─ Basel, Switzerland-based Roche said on Tuesday that it has received US Food and Drug Administration approval for use of its Cobas HIV-1/HIV-2 Qualitative Test on its fully automated real-time PCR-based Cobas 6800 and 8800 systems.

Roche's Cobas HIV-1/HIV-2 assay is a nucleic acid amplification test for the qualitative detection and differentiation of HIV-1 and HIV-2 RNA in human serum and plasma.  

The assay enables confirmatory HIV testing and HIV-1/HIV-2 differentiation in a single test.

The presence of HIV-1 or HIV-2 nucleic acid in the plasma or serum of individuals without antibodies to HIV-1 or HIV-2 is indicative of acute or primary infection.

Roche's test provides healthcare professionals with a single result to confirm HIV diagnosis and differentiate HIV-1 and HIV-2, an important distinction needed to identify appropriate treatment options, the firm said.

Its Cobas HIV-1/HIV-2 Qualitative assay may be used as an additional test to confirm the presence of HIV-1 or HIV-2 infection in an individual with specimens reactive for HIV-1 or HIV-2 antibodies or antigens. The assay may also be used as an aid in the diagnosis of infection with HIV-1 and/or HIV-2 in pediatric subjects and pregnant women.

"Being able to reliably determine a person’s HIV status and accurately diagnose which HIV type they may have is crucial for patients and healthcare providers in preventing further community transmission and selecting an individual’s best treatment options," Thomas Schinecker, CEO of Roche Diagnostics, said in a statement.

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