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)

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