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03-27 2019

Vela Announces FDA Submission for HIV Genotyping and DRM Assay

Author:Luye Life Sciences

Vela announces FDA submission for the Sentosa® SQ HIV Genotyping Assay, a NGS genotyping and DRM detection IVD test intended for use as an aid in monitoring and treating HIV-1 infection.

Vela Diagnostics announced today the submission of the Sentosa® SQ HIV Genotyping Assay to the U.S. Food and Drug Administration (FDA). The Sentosa® SQ HIV Genotyping Assay is intended for the detection of HIV-1 Group M genomic drug resistance mutations (DRMs) in the protease, reverse transcriptase, and integrase  regions of the pol gene. The test uses the plasma of patients diagnosed with HIV-1 infection. This submission follows the U.S. FDA clearance of Vela’s Sentosa® SA201 HSV-1/2 PCR Test, received in February 2018.

“This submission of our first next generation sequencing assay to the U.S. FDA signifies our continued commitment to bringing relevant products to clinicians to help their patients in globally regulated markets around the world, which is among Vela’s top priorities. With the NGS HIV Genotyping assay, laboratories will now have a sample-to-answer solution that addresses the needs of HIV treatment,” commented Sam Dajani, Chairman of the Board.

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 automated reporting.  The Sentosa® NGS workflow also allows clear sample traceability, with seamless LIS integration and connectivity.

The system generates a clinical interpretation report, based on the detected mutations, using an on-board version of the world class Stanford database. This report provides information on drug resistances associated with the detected mutations. The Sentosa® SQ HIV Genotyping Assay utilizing the Sentosa® NGS workflow is highly sensitive and delivers clinically relevant results with reduced hands-on and turnaround time in comparison to Sanger and other non-automated NGS alternatives.

Resistance of HIV to antiretroviral drugs as a result of DRMs is the most common cause of therapeutic failure in people infected with HIV. The detection and reporting of DRMs is critical for optimal selection of Highly Active Antiretroviral Therapy (HAART) regimen and can prevent or minimize the development of resistance to antiviral drugs.  According to the “Global report on early warning indicators of HIV drug resistance” published by the 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 favorable for the emergence of preventable HIVDR.” However, almost all molecular diagnostics tests for HIVDR are currently unavailable in the in vitro diagnostics (IVD) market.The submission of the Sentosa® SQ HIV Genotyping Assay to the FDA by Vela Diagnostics is a step forward in bringing molecular diagnostics for HIVDR to patients.

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