InDevR expands VaxArray antibody license with FDA to provide new potency test kit for 2018/2019 season
BOULDER (4/10/18) — InDevRexpanded its license agreement with the Technology Transfer Program at the US Food and Drug Administration (FDA) to address strain changes recommended by the World Health Organization (WHO) for 2018/2019 seasonal influenza vaccines. The new VaxArray® Influenza Seasonal HA reagent kit (v2.0) has improved sensitivity to the latest A/H3N2 and B/Victoria-like viruses. Version 2.0 of the potency test is available now for evaluation and will be available for purchase by April 21, 2018.
This rapid response to strain changes highlights one of the benefits of the VaxArray potency testing platform; specifically, the speed and efficiency with which these updates can be made. As an example, the WHO announced the strain changes for inclusion in the seasonal influenza vaccine for the Northern Hemisphere on February 22, 2018. Based on established timelines, the reference reagents required for the traditional single radial immunodiffusion (SRID) potency test are not expected to be available until July of 2018. Thus, the new VaxArray reagent kit will be available 3-4 months earlier than traditional potency reagents. The VaxArray assay is also 24x faster than SRID, uses 10x less sample, and requires 12x less hands-on time.
While the current version (v.1.2) of the VaxArray® Influenza Seasonal HA reagent kit has been responsive to influenza viruses exhibiting antigenic drift over a 10+ year time period, the recent strain change necessitated an update to the reagent kit and that update was implemented in accordance with the continuous product quality assurance program established by InDevR for the VaxArray product line. Version 2.0 will offer improved sensitivity and accurate potency testing for the 2018/2019 seasonal influenza vaccine. InDevR will continue to offer v1.2 of the reagent kit as an option to customers working with older influenza strains.
InDevR also recently announced the availability of 21 CFR Part 11 compatible software for the VaxArray platform. This new software sets a whole new standard for data integrity in vaccine potency testing.
Find more information about the entire VaxArray product line at: https://indevr.com/products/vaxarray/
This work was sponsored as part of the Department of Health and Human Services’ inter-agency Influenza Vaccine Improvement Initiative. Specifically, product development was supported by a Small Business Innovation Research grant R44AI102318 through 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.