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Vela Diagnostics' Sentosa SQ HIV-1 Genotyping Assay Receives the US FDA's DE Novo Authorization for Detection of HIV-1 Genomic Drug Resistance Mutations (DRMs)

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Vela Diagnostics' Sentosa SQ HIV-1 Genotyping Assay Receives the US FDA's DE Novo Authorization for Detection of HIV-1 Genomic Drug Resistance Mutations (DRMs)

Shots:

  • The novel HIV-1 Genotyping assay uses the plasma of patients infected with HIV-1 to detect HIV-1 Group M DRMs in the protease- reverse transcriptase- and integrase regions of the pol gene- in a single test
  • Sentosa SQ HIV-1 Genotyping Assay is programmed on Sentosa NGS workflow enabling RNA extraction- PCR setup- library construction- template preparation- sequencing- data analysis- and automated reporting offering sample traceability- with seamless LIS integration and connectivity
  • The assay delivers sensitive and relevant results with less hands-on time used for the detection of HIV-1 genomic DRMs while received Thai FDA approval in Aug’ 2019 with pending review for CE mark and the HSA. In 2017- an earlier version of Sentosa SQ HIV Genotyping Assay received CE mark- TGA approval- and HSA

Click here to­ read full press release/ article | Ref: Vela Diagnostics | Image: Classic Exhibits


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