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BioWorld - Sunday, January 11, 2026
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» FDA authorizes first NGS test to detect critical HIV-1 drug resistance mutations
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FDA authorizes first NGS test to detect critical HIV-1 drug resistance mutations
Nov. 7, 2019
By
Meg Bryant
Singapore-based Vela Diagnostics Holding Pte. Ltd. has received U.S. FDA authorization via the de novo approval pathway for an in vitro diagnostic test to detect HIV-1 genomic drug resistance mutations (DRMs).
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Medical devices and technologies