An important HIV-1 genotyping assay that can detect drug-mutations in the virus' Pol gene has been granted FDA De Novo authorization, allowing its marketing in the US. The Vela Diagnostics Sentosa® SQ HIV-1 Genotyping Assay is the first of its kind to receive authorization from the US FDA. 

The Sentosa SQ HIV-1 assay is validated on the Sentosa NGS workflow that enables automated RNA extraction, PCR setup, library construction, template preparation, sequencing, data analysis, and automated reporting. The workflow also offers clear sample traceability, with LIS integration and connectivity. 

Using a standalone version of the curated Stanford University HIV Drug Resistance Database to ensure traceability of the DRM interpretation report, the system generates a clinical interpretation report that provides information on drug resistances associated with the detected mutations. 

Compared to Sanger bi-directional sequencing and other non-automated NGS alternatives, the Sentosa® SQ HIV-1 Genotyping Assay utilizing the Sentosa® NGS workflow is highly sensitive and delivers clinically relevant results with reduced hands-on time (<2 hours combined), and turnaround time (2 days).

Resistance of HIV-1 to antiretroviral drugs as a result of DRMs is the most common cause of therapeutic failure in patients with HIV-1 infection. The detection and reporting of DRMs is crucial for optimal selection of Highly Active Antiretroviral Therapy (HAART) regimens and can prevent or minimize the development of resistance to antiviral drugs. The World Health Organization (WHO) recommends monitoring and reporting early warning indicators (EWI) of HIV drug resistance as a key component of public health strategy when scaling up antiretroviral therapy.