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Vela Diagnostics Submits NGS HIV Genotyping, Drug Resistance Assay to FDA

NEW YORK (GenomeWeb) – Vela Diagnostics has submitted a next-generation sequencing assay that detects HIV-1 drug resistance mutations (DRMs) to the US Food and Drug Administration, the company announced today.  

The Sentosa SQ HIV Genotyping Assay can be used on plasma samples from patients with HIV-1 infection to detect HIV-1 Group M genomic DRMs in the protease, reverse transcriptase, and integrase regions of the pol gene. Resistance to antiretroviral drugs as a result of DRMs is the most common cause of therapeutic failure in HIV treatment.

The assay is validated on the automated Sentosa NGS workflow, the company said in a statement. The Sentosa workflow enables automated RNA extraction, library construction, template preparation, sequencing, data analysis, and automated reporting.

The system also generates a clinical interpretation report that provides information on drug resistances associated with any mutations detected.

The Sentosa SQ HIV Genotyping Assay was CE marked in 2017, and Vela's PCR-based assay for herpes simplex virus cleared the FDA last year. The firm also acquired the assets of Great Basin Diagnostics and relisted them under its name last year as part of a strategy to accelerate the Singapore-based firm's entrance into the US market by providing decentralized testing options.