FDA approves new genotypic assay test for HIV resistance

  • FDA Newsroom
  • U.S. Food & Drug Administration
  • 6 nov. 2019

  • de Liz Scherer
  • Clinical Essentials
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Takeaway

  • FDA has approved the Sentosa SQ Genotyping Assay to detect HIV drug resistance.
  • Assay test is indicated for use in HIV-1-infected patients initiating or already taking antiretroviral therapy (ART) and is not intended for diagnostic purposes.

Why this matters

  • Single-test assay detects HIV-1 Group M drug-resistant mutations (e.g., protease, reverse transcriptase, integrase regions of the pol gene) in plasma, using next-generation sequencing technology.
  • Test facilitates individualized ART, identifies mutations that might reduce effectiveness of certain agents, and provides data on which drugs may no longer be effective.

Key points

  • The system generates a clinical interpretation report to provide clinicians with information on drug resistances associated with detected mutations.
  • Performance studies demonstrated >95% sensitivity and specificity for 342 HIV drug-resistant mutations.
  • Marketing approval was based on a de novo premarket review pathway whereby devices can obtain clearance by meeting specific and general control criteria and demonstrating substantial equivalence to a predicate device.
  • Manufacturer reports less hands-on laboratory time (