- 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.
- 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 (