Clinical validation of the FluChip-8G Influenza A+B Assay for influenza type and subtype identification
published in Journal of Clinical Virology
Analytical Evaluation of the Microarray-Based FluChip-8G Influenza A+B Assay published in Journal of Virological Methods
Analytical Evaluation of the Microarray-Based FluChip-8G Influenza A+B Assay
published in Journal of Virological Methods
[Press Release] New VaxArray Neuraminidase Potency Test for N9
[Press Release] New VaxArray Neuraminidase Potency Test for N9
InDevR launches first-in-class reagent kit for rapid quantification of N9 in
“pandemic” influenza vaccines.
BOULDER COLORADO (3/26/19) — InDevR Inc. announced commercial availability of a VaxArray reagent kit for neuraminidase (NA) from influenza viruses containing the N9 subtype. Together with InDevR’s VaxArray reagent kit for “pandemic” hemagglutinin (H5, H7, H9), the new N9 reagent kit can provide unprecedented insight into the relationship between influenza vaccine antigen content and clinical efficacy for vaccines to be included in the nation’s emergency stockpile.
The level of neuraminidase in flu vaccines is not currently regulated but its “presence and type must be confirmed by suitable enzymatic or immunological methods” during vaccine manufacturing. The portfolio of VaxArray NA reagents kits, which include the only commercially available potency tests for N9, N1, N2, and B-NA, can be used to efficiently address both identity and presence of NA in flu vaccines manufactured by egg, cell, or recombinant technology. The VaxArray assays are subtype specific, quantitative, correlated with enzymatic activity, stability indicating, and can serve as a proxy for immunogenicity.
The VaxArray neuraminidase assays are expected to reduce the time and cost associated influenza vaccine production as well as facilitating improvement of influenza vaccines.
“Improving our understanding the role of neuraminidase is an important component of this effort of improving influenza vaccines. Together with studying the immune response elicited by influenza vaccines against HA, we are interested in understanding the potential contribution of NA, as we believe this might lead to more effective seasonal and pandemic influenza vaccines. Indeed, we are currently exploiting the VaxArray platform to characterize the NA content in a pre-pandemic whole virion H5N1 vaccine candidate.”
said Dr. Kutub Mahmood, Scientific Director at PATH.
InDevR also offers VaxArray potency assays for influenza seasonal hemagglutinin and nucleoprotein. Find more information about the entire VaxArray product line at: https://indevr.com/products/vaxarray/
Development of the VaxArray platform was sponsored as part of the Department of Health and Human Services’ inter-agency Influenza Vaccine Improvement Initiative through a Small Business Innovation Research grant R44AI102318 from the National Institute of Allergy and Infectious Diseases, which is part of the National Institutes of Health (NIH). The content is solely the responsibility of the authors and does not necessarily represent the official views of the NIH.
About InDevR
InDevR is a global leader in progressive new analytical technologies that enable accelerated development and manufacturing of vaccines and other biotherapeutics. For more information about the company and products, please visit www.indevr.com or call 303-402-9100.
About PATH
PATH is a non-profit organization working toward sustainable production of high-quality, affordable seasonal and pandemic influenza vaccines in developing countries – including innovative broadly protective influenza vaccines.
MEDIA CONTACT
Shannon Rodriguez
InDevR
+1-303-402-9100
New npj Vaccines Paper on Influenza Neuraminidase Potency
New npj Vaccines Paper on Influenza Neuraminidase Potency
Open Full Publication Byrne-Nash_et_al-2019-npj_Vaccines-SM.pdf (140 downloads)
[Press Release] FluChip-8G® Insight Evaluated for Enhanced Influenza Surveillance in Southeast Asia
[Press Release] FluChip-8G® Insight Evaluated for Enhanced Influenza Surveillance in Southeast Asia
InDevR collaborating with Armed Forces Research Institute of Medical Sciences to test FluChip-8G Insight™
BOULDER (12/4/18) — InDevR scientists are collaborating with scientists at the Armed Forces Research Institute of Medical Sciences (AFRIMS), part of the Walter Reed Army Institute of Research, to evaluate the performance of FluChip-8G Insight system for rapidly characterizing influenza virus subtype from human and animal-origin samples. The research-use-only FluChip-8G Insight assay is not intended for diagnostic purposes but rather as a fast and easy way to determine the subtype of seasonal and non-seasonal influenza viruses.
The FluChip-8G Insight system has been installed at AFRIMS sites in Bangkok, Kathmandu, and Manila. AFRIMS conducts influenza surveillance throughout the world as part of a global network of sites keeping track of influenza viruses circulating in humans and animal populations.
Colonel Louis Macareo, Chief of the Department of Virology at AFRIMS commented that “We are pleased to collaborate with InDevR scientists to evaluate the performance of FluChip-8G Insight system for rapidly characterizing influenza viruses.” AFRIMS scientists plan to test the system at AFRIMS headquarters in Bangkok Thailand, at the Walter Reed AFRIMS Research Unit Nepal (WARUN), and at the Philippines-AFRIMS Virology Research Unit (PAVRU). All three sites will conduct side-by-side performance comparison with real-time RT-PCR assays for typing and subtyping influenza viruses being utilized as part of DoD surveillance efforts. The long-term objective is to qualify the system for reflex testing of influenza positive samples for rapid identification of influenza A subtype and influenza B lineage.
FluChip-8G leverages advancements in artificial intelligence to distill complex data into a simple answer to identify flu viruses. The technology is based on a microarray that quickly probes a large portion of influenza’s viral genome. Human experts who have the required skill to curate and interpret such a massive amount of data from each sample are hard to come by, especially in remote locations where new flu viruses with pandemic potential are likely to originate. To tackle that problem, the developers of FluChip-8G built an “expert” into every box. Similar to the way social media sites are able to identify individual faces in a photograph, the FluChip-8G system uses a pattern recognition algorithm to rapidly identify flu viruses. This allows those tracking flu viruses in a variety of settings including low and middle-income countries to rapidly determine if a flu virus with pandemic potential is causing infections or outbreaks.
According to Dr. Nancy Cox, the former Director of the CDC’s Influenza Division and the WHO Collaborating Center for Influenza in Atlanta, “By eliminating analysis of large amounts of complex data generated by whole genome sequencing, the FluChip-8G technology fulfills the need for immediate answers in surveillance labs distributed throughout the world that have less resources.”
This reaction was echoed by Dr. Rangarajan Sampath, the Chief Scientific Officer at FIND “The FluChip-8G technology seems very promising for filling a critical niche in global influenza surveillance. The current approaches for identifying non-seasonal viruses are inadequate and/or time consuming.”
Advanced development was funded by the Biomedical Advanced Research and Development Authority (HHSO100201400010C, HHS0100201500024C).
About InDevR
InDevR is a leader in progressive new diagnostic and analytical technologies that enable accelerated development and manufacturing of vaccines and other biotherapeutics. For more information about the company and products, please visit www.indevr.com or call 303-402-9100.
MEDIA CONTACTS
Shannon Rodriguez
InDevR
+1-303-402-9100
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