Vela Diagnostics Receives CE-IVD for HIV Genotyping Test

Vela Diagnostics Sentosa® SQ HIV Genotyping Assay receives CE-IVD approval

Singapore (August 21, 2017) – Vela Diagnostics announced today that the Next Generation Sequencing (NGS)-based Sentosa® SQ HIV Genotyping Assay is now CE-IVD marked for in-vitro diagnostics use. The Sentosa® SQ HIV Genotyping Assay is intended for the detection of HIV-1 Group M genomic mutations in Protease, Reverse Transcriptase and Integrase regions from plasma in patients diagnosed with HIV infection. 

The Sentosa® SQ HIV Genotyping Assay is validated on the highly automated Sentosa® NGS workflow which enables automated RNA extraction, library construction, template preparation, sequencing, data analysis and generation of both Pathology report and Quality Control report. The Sentosa® NGS workflow also allows clear sample traceability, with seamless LIS integration and connectivity. 

The Sentosa® SQ HIV Genotyping Assay on Sentosa® NGS workflow is highly sensitive and delivers clinically relevant results with reduced hands on - and turn around time in comparison to Sanger and other non automated NGS alternatives. The automated workflow is validated to process clinical samples with as low as 1,000 copies/mL of HIV viral load. This highly sensitive assay is also able to detect as low as 5% variant frequency at 4000 copies/mL viral load, and has demonstrated 98.50% clinical sensitivity in all three target regions, 99.82% variant detection correctness, with 100% reproducibility. 

Resistance of HIV to antiretroviral drugs (DRM) is the most common cause for therapeutic failure in people infected with HIV. Detection and Reporting of DRM’s is critical for optimal selection of Highly Active Antiretroviral Therapy (HAART) regimen and can prevent or minimise the development of resistance to antiviral drugs.  According to “Global report on early warning indicators of HIV drug resistance” published by World Health Organization (WHO) in July 2016, “since 2011, monitoring and reporting of early warning indicators (EWI) of HIVDR has decreased globally. In 2015, only a handful of countries reported implementing EWI monitoring – a fact that may place many countries at serious risk of unknowingly creating situations favourable to the emergence of preventable HIVDR” [1]. However, almost all molecular diagnostics tests for HIVDR are currently off the in vitro diagnostics (IVD) market.  

To learn more about Sentosa® NGS workflow and test menu, visit http://www.veladx.com/products.html#ngs

[1] WHO. Global report on early warning indicators of HIV drug resistance: technical report, July 2016. 64pp.
 
 
 
 

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