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Home » Business, Policy & Funding » Regulatory News & FDA Approvals » Roche Receives FDA Approval for HIV-1/HIV-2 Qualitative Molecular Test

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

Sep 01, 2020
|
staff reporter

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.

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