Vela Diagnostics has developed Sentosa SQ HIV-1 Genotyping Assay for detecting HIV-1 drug resistance mutations (DRMs)
Image: Vela Diagnostics secures FDA De Novo Designation for HIV-1 genotyping assay. Photo: Courtesy of Belova59 from Pixabay.
Vela Diagnostics has secured US Food and Drug Authority (FDA) authorisation to market its Sentosa SQ HIV-1 Genotyping Assay for the detection of HIV-1 genomic drug resistance mutations (DRMs).
Using the plasma of patients infected with HIV-1, the company’s in-vitro diagnostic test detects HIV-1 Group M DRMs in the protease, reverse transcriptase, and integrase regions of the pol gene, in a single test.
Vela Diagnostics acting CEO and board chairman Sam Dajani said: “The granting of the De Novo designation of our NGS assay by the U.S. FDA is a major milestone in HIV diagnostics.
“VELA strives to bring relevant products to clinicians to help patients around the world. 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.”
Sentosa SQ HIV-1 is the first and only FDA authorised HIV-1 genotyping NGS assay
According to the company, the most common cause of therapeutic failure in patients with HIV-1 infection is HIV-1 building-up resistance to antiretroviral drugs.
Detection and reporting of DRMs is crucial in selecting optimal highly active antiretroviral therapy (HAART) regimens and prevent the development of resistance to antiviral drugs.
Vela Diagnostics said that its Sentosa SQ HIV-1 marks the first and only HIV-1 genotyping NGS assay to secure marketing authorisation from the US FDA.
The assay is authenticated on the Sentosa NGS workflow that facilitates automated RNA extraction, PCR setup, library construction, template preparation, sequencing, data analysis, and automated reporting, along with clear sample traceability, easy LIS integration and connectivity.
In addition, the system generates a clinical interpretation report with 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 DRM interpretation report.
The company said that using Sentosa NGS workflow, the new Sentosa SQ HIV-1 Genotyping Assay would work precisely and deliver results with reduced hands-on time, and turnaround time, compared to Sanger bi-directional sequencing and other non-automated NGS alternatives