Vela Diagnostics Launches Next-Generation Sequencing-Based Assay that Detects Drug Resistance Mutations in Human Immunodeficiency Virus, Hepatitis C Virus, Hepatitis B Virus and Cytomegalovirus

The ViroKey™ SQ FLEX Genotyping Assay (4x16) detects mutations associated with drug resistance in HIV-1, HCV, HBV and CMV and allows multiple tests to be combined in a single run.

Singapore, May 11 2020 - Vela Diagnostics announced that it has launched the ViroKey™ SQ FLEX Genotyping Assay (4x16). The assay is a next-generation sequencing-based test that detects drug resistance mutations (DRMs) in nucleic acids from the Human Immunodeficiency virus (HIV-1), Hepatitis C virus (HCV), Hepatitis B virus (HBV) and Cytomegalovirus (CMV).

HIV-1, HCV, HBV and CMV are major viral pathogens and millions around the world live with HIV-1, HCV, HBV and CMV infections. As a result of widespread antimicrobial drug use, antimicrobial resistance of these viruses has escalated in recent years. “Drug resistance of HIV-1, HCV, HBV and CMV is a rising problem and there is a need to identify DRMs in these pathogens for effective monitoring and treatment of patients. However, it may be cost-prohibitive for laboratories which process low or varying sample volumes of these assays to provide a quick turnaround time or to even offer these tests. A cost-effective and flexible solution is needed,” said Dr. Charlie Lee, Head of Research and Development. 

The ViroKey™ SQ FLEX Genotyping Assay (4x16), available for research use, consists of 4 tests that are performed on Vela Diagnostics’ automated workflow consisting of the Sentosa™ SX101, Sentosa ST401 and Sentosa SQ301 instruments.

  • The HIV-1 test detects mutations in the protease, reverse transcriptase and integrase regions of the pol gene of the Group M subtypes.
  • The HCV test detects DRMs in the NS3, NS5A and NS5B genes.
  • The HBV test detects mutations associated with drug resistance in the reverse transcriptase, surface gene, basal core promoter, pre-core and core regions.
  • The CMV test detects mutations in the UL54, UL97, UL56, UL51, UL27 and UL89 genes that confer resistance to antiviral drugs.

A unique feature of the ViroKey™ SQ FLEX Genotyping Assay (4x16) is that it enables laboratories to process up to 16 samples (including controls) of any combination of the 4 tests simultaneously in a single run. This game-changing flexibility to combine multiple tests into a single run provides laboratories with a highly cost-effective solution as they can now batch tests that are of lower volumes with tests that are of higher volumes. Moreover, laboratories with sufficient volumes for single tests retain the flexibility to perform individual tests in a single run using the same assay.

While the ViroKey™ SQ FLEX Genotyping Assay has an initial offering of 4 genotyping tests (HIV-1, HCV, CMV and HBV), there is potential for other virology tests to be brought onto the same platform. For example, an application that allows laboratories to combine HIV proviral DNA samples, extracted via their own methods, with HIV plasma samples on the same run using the HIV-1 test was recently developed on request.

The ViroKey™ SQ FLEX Genotyping Assay (4x16) is the latest product in Vela Diagnostics’ FLEX portfolio that provides flexible automated solutions for NGS and qPCR to laboratories. Previously, Vela Diagnostics developed a flexible automated workflow solution on its qPCR platform to detect and quantify up to 4 viruses that cause disease in immunocompromised individuals in one run.

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 enabling tests to be performed 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

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