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NEW YORK – The US Food and Drug Administration announced Tuesday that it has authorized Vela Diagnostics' next-generation sequencing-based HIV-1 drug resistance mutation assay for marketing through its de novo premarket review pathway.

The agency said the test — called the Sentosa SQ HIV Genotyping Assay — is the first HIV drug resistance assay utilizing NGS technology that the FDA has authorized for marketing in the US.

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