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FDA grants de novo designation to NGS HIV-1 genotyping assay

December 2019—Vela Diagnostics received FDA authorization to market its in vitro diagnostic test for the detection of HIV-1 genomic drug resistance mutations.

The Sentosa SQ HIV-1 Genotyping Assay uses the plasma of patients infected with HIV-1 to detect HIV-1 Group M drug resistance mutations in the protease, reverse transcriptase, and integrase regions of the pol gene, in a single test. It is the first HIV-1 genotyping NGS assay to receive marketing authorization from the FDA.

In a Nov. 5 statement, Vela acting CEO and chairman of the board Sam Dajani called the FDA’s granting of the de novo designation to the NGS assay “a major milestone in HIV diagnostics.”

“With the Sentosa SQ HIV-1 Genotyping Assay, laboratories will now have a sample-to-report solution to aid in monitoring and treating HIV-1 infection,” he said.

The 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, Vela said in the statement.

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

Compared with Sanger bidirectional sequencing and other nonautomated NGS alternatives, Vela says, the Sentosa SQ HIV-1 Genotyping Assay using the Sentosa NGS workflow is highly sensitive and delivers clinically relevant results with reduced hands-on time (less than two hours combined) and turnaround time (two days).

In 2017, an earlier version of the Sentosa SQ HIV Genotyping Assay received the CE mark and was approved by the Australian Therapeutic Goods Administration and Singapore Health Sciences Authority. In August 2019, the assay received approval from the Thai FDA. The current configuration of the assay is pending review for the CE mark and from the Singapore HSA.

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