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• Performance evaluation of the new Roche Cobas AmpliPrep/Cobas TaqMan HIV-1 test version 2.0 for quantification of human immunodeficiency virus type 1 RNA.
• Comparison of the Abbott Realtime HIV-1 and HCV viral load assays with commercial competitor assays.
• Evaluation of the analytical performance of the new Abbott RealTime RT-PCRs for the quantitative detection of HCV and HIV-1 RNA.
• Multicenter evaluation of the new Abbott RealTime assays for quantitative detection of human immunodeficiency virus type 1 and hepatitis C virus RNA.

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LATEST PRESS RELEASE

Hitting multiple targets with Viroclinics Biosciences’ Rhino and Entero diagnostics platform

In this case study article Viroclinics Biosciences‘ team member Saskia Smits sheds light on a customized research model, designed to tackle the challenge of typing multiple Rhino- and Enteroviruses.

Saskia Smits holds the position of Director Molecular Virology Services at Viroclinics Biosciences. She brings more than 15 years of leading virology expertise to the table. After obtaining her PhD in Molecular Virology, she started an academic career as postdoctoral researcher at Utrecht University and Erasmus Medical Centre. Her academic background in researching multiple viruses, such as SARS Coronavirus, Hepatitis C and Torovirus proved to be a solid basis when she embarked on a new role of Sr. Scientist at Viroclinics Biosciences. She quickly rose through the ranks and became Study Director in 2016. With specialized expertise in virus detection methods, she was the perfect candidate for designing a complex Rhino/Enterovirus assay platform.

Industry Requirements

With limited options available for antiviral treatment and vaccines against Rhino/Enterovirus (HRV/EV), there is potential for the Biotech/ Pharmaceutical community to develop new antivirals and to improve vaccines. Potential health related risks are high, which is emphasized by recent outbreaks in Canada, the US (EV-D68 20141) and in the Asia-Pacific Region (EV-A712). Saskia: “The constellation of high risk factors, including a wide variety of viruses, forms a major challenge for the Biotech/ Pharmaceutical community. We are often faced with several diagnostics difficulties and challenged to provide pragmatic solutions in relation to the following research queries”:

  1. How to type multiple Rhino- and Enteroviruses, while there is no one fits all assay solution?
  2. How to detect and quantify HRV/EV viral genome?
  3. How to monitor Phenotypic resistance in a clinical trial setting?
  4. How to confirm Phenotypic resistance through Genotypic resistance monitoring?
  5. Keeping in mind the high variety of Rhino- and Enteroviruses, and sub classifications, how to stay focused in this study?
  6. How to operationalize this study in a cost efficient way?

Summarized, there is a need for diagnostics outsourcing partners with a track record in specialized virology studies with the capabilities to deal with complex typing studies.

Our Solution

Phase 1
Saskia: “We propose a multi-phase model, starting with a HRV/EV subtyping assay. The HRV/EV typing Sanger sequencing assays are based on VP4/ VP2 for HRV testing and VP1 for EV typing. The assays are developed and validated in combination with an automated analysis pipeline with a curated database of all currently classified rhino- and enterovirus subtypes at its base, allowing HRV and EV subtype classification within minutes. Viruses that cannot be classified as single known types are confirmed by follow-up phylogenetic analysis.

Rhino- and Enteroviruses
Rhino- and enteroviruses belong to the Picornaviridae family and enterovirus genus and cause neurological and respiratory related infections. Currently there are 116 known enteroviruses classified in 4 entero- and 3 rhinovirus species. A majority of enterovirus infections cause asymptomatic infections.

Projected Results

Saskia: “We suggest a research approach focused on delivering ambitious performance targets”

  • We are capable of meeting Rhinovirus typing requirements in terms of validation parameters like accuracy, repeatability and detection limits;
  • All operational delivery deadlines will be met within the agreed timelines.
  • A high percentage of enterovirus types can be classified as a single known correct type;
  • Viroclinics Biosciences’ molecular laboratory will be able to detect a large proportion of viruses in clinical samples.

Phase 2 – HRV / EV platform
Based on previous experience, Viroclinics Biosciences has set up an entire HRV/EV platform including quantitative viral load determination using quantitative RT-PCR and culture-based virus titration, phenotypic resistance monitoring through IC50 assays and whole genome rhino- and enterovirus genotypic characterization using next generation sequencing.

HRV/ EV Typing with PCR
Polymerase Chain Reaction is a proofed analytical method. It requires significant investment in high tech equipment, laboratory space and scientific staff and is therefore an ideal technique to outsource to specialized CRO partners in the clinical trial network.

Viroclinics Biosciences’ HRV / EV Platform*

Research Element / PhaseAssay
Quantitative Viral LoadCell Culture Virus Titration / qRT-PCR
EV/ RV typingSanger sequencing
Resistance Monitoring / AnalysisIC50 Assay
Further In-Depth CharacterizationNext-Gen Sequencing

*[Several similar assay platforms are available for other viruses as well. Find out more here about our other assay platforms and viral targets.]

Viroclinics Biosciences’ HRV / EV Platform*

The key differentiators that define the success of our assay platform are: specialized virology experience, high-throughput delivery and the capability to perform multiple assay types, including Next-Gen sequencing.

Saskia Smits

Director Molecular Virology Services, Viroclinics

Additional Information

  • Our suggested HRV/ EV platform can be replicated and customized.
  • For further discussion in relation to this article, please contact us here.
  • Here you can read more about our other assay platforms and viral targets.
  • Please visit the Pubmed Section of our website for our latest scientific contributions.

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