Singapore, Singapore (December 9, 2019) - Vela Diagnostics announced today that the Singapore Health Sciences Authority (HSA) has approved its Sentosa® SQ HIV-1 Genotyping Assay as a Class C IVD Device under the Priority Full Evaluation Route. The Sentosa® SQ HIV-1 Genotyping Assay uses the plasma of patients infected with HIV-1 to detect HIV-1 Group M DRMs in the protease, reverse transcriptase, and integrase regions of the pol gene, in a single test.
“Singapore is at the forefront of molecular diagnostics and the approval of our NGS assay by HSA is a major milestone in HIV diagnostics for the region. With the Sentosa® SQ HIV-1 Genotyping Assay, laboratories will now have a highly specific and sensitive sample-to-report solution to aid in monitoring and treating HIV-1 infection,” said Sam Dajani, acting CEO & Chairman of the Board.
The Sentosa® SQ HIV-1 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.
The associated software uses standalone versions of the Stanford HIVdb, ANRS and Rega algorithms to generate 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.
In November 2019, the assay was granted De Novo designation by the U.S. FDA, making it the first and only HIV-1 genotyping NGS assay currently available on the market to receive marketing authorization from the FDA. The assay is also pending review for the CE mark.
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.