Thai FDA approves Vela Diagnostics’ Sentosa® SQ HIV Genotyping Assay Next Generation Sequencing (NGS) assay for detecting HIV-1 drug resistance mutations (DRMs).
Singapore, Singapore (August 23, 2019) - Vela Diagnostics has received Thai FDA approval for its in vitro diagnostic test for the detection of HIV-1 genomic drug resistance mutations (DRMs). In a single test, the Sentosa® SQ HIV Genotyping Assay detects HIV-1 Group M DRMs in the protease, reverse transcriptase and integrase regions of the pol gene, using the plasma of patients infected with HIV-1.
“The approval of our NGS assay by Thai FDA offers a highly specific and sensitive diagnostic option for patients living with HIV in Thailand. With the Sentosa® SQ HIV Genotyping Assay, laboratories will now have a sample-to-result solution to aid in monitoring and treating HIV-1 infection,” said Sam Dajani, CEO & Chairman of the Board.
The Sentosa® SQ HIV Genotyping 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 seamless LIS integration and connectivity.
Compared to Sanger bi-directional sequencing and other non-automated NGS alternatives, the Sentosa® SQ HIV 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).
In 2018, it was estimated that 480,000 people in Thailand are living with HIV, with 6,400 new HIV infections every year. Resistance of HIV-1 to antiretroviral drugs 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.
In 2017, the Sentosa® SQ HIV Genotyping Assay received the CE mark, and was approved by the TGA (Australian Therapeutic Goods Administration) and HSA (Singapore Health Sciences Authority).
About Vela Diagnostics
Vela Diagnostics is a leading provider of an automated IVD Next–Generation Sequencing (NGS) workflow in the global diagnostics market. VELA’s real-time PCR and NGS applications are available on an integrated Sentosa® platform; this provides a unique ability to leverage one system for two workflows, while carrying out tests for various targets in order to answer current clinical and research questions, as well as to drive laboratory operational efficiency. All Sentosa® products listed above are by Vela Diagnostics. For more information, visit www.veladx.com.