ASM Microbe 2019
InDevR will be present at the ASM conference in San Francisco in June. Rose Nash will be offering a presentation, “Assessment of the Correlation between Alternative Influenza Vaccine Potency Assays and Immunogenicity in Mice.”
InDevR receives 510(k) market clearance for the first influenza diagnostic assay capable of distinguishing between seasonal and non-seasonal influenza A subtypes
BOULDER COLORADO (4/30/19) — InDevR Inc., a leader in progressive analytical technologies, announced today that they have received 510(k) market clearance for their FluChip-8G Influenza A+B Assay from the United States Food and Drug Administration (FDA).
FluChip-8G is the first cleared influenza diagnostic capable of positively characterizing a wide variety of viruses as “non-seasonal” and characterizing seasonal viruses in a single multiplexed assay with same-day results.
According to Dr. Nancy Cox, retired former director of the Influenza Division within the Centers for Disease Control and Prevention,
“This is a tremendous accomplishment by the extraordinary team of scientists and engineers at InDevR.. I applaud their efforts to develop an in vitro diagnostic that can be used as an early warning system for the emergence of new strains of influenza.”
The in vitro diagnostic assay was developed for the qualitative detection and differentiation of seasonal and non-seasonal influenza A viruses as well as the genetic lineage of influenza B viruses. Importantly, the assay is capable of detecting a wide variety of non-seasonal influenza A viruses and positively identifying them as “non-seasonal”, including subtypes with recognized pandemic potential such as H7N9 and H5N1. The open platform molecular diagnostic system consists of a low-density microarray and reagent kit, microarray imaging system, and custom software. The assay is based on multiplexed RT-PCR amplification of whole influenza gene segments in combination with detection on a microarray and subsequent AI-based pattern-recognition for automated interpretation.
Dr. Erica Dawson, InDevR’s Chief Technology Officer said:
“We are excited about InDevR’s first 510(k) market clearance for the FluChip-8G Influenza A+B Assay. This successful clearance follows several years of assay development with the goal of improving the nation’s preparedness to respond to an influenza pandemic. We hope that placement of this FluChip-8G technology in the field will bring us another step closer to ensuring timely detection of emerging influenza threats.”
Early development of the FluChip-8G technology was supported by a Small Business Innovation Research Grant R43/44 AI077112 through the National Institutes for Allergy and Infectious Disease (NIAID); National Institutes of Health (NIH). Advanced development of the FluChip-8G platform has been funded in whole or in part with Federal funds from the Department of Health and Human Services; Office of the Assistant Secretary for Preparedness and Response; Biomedical Advanced Research and Development Authority, under Contract No. HHSO100201400010C and HHSO100201500024C.
The content of this news release is solely the responsibility of the authors and does not necessarily represent the official views of the NIH or BARDA.
InDevR is a global leader in progressive new analytical technologies that enable accelerated development and manufacturing of vaccines and other biotherapeutics. Other InDevR products include the VaxArray portfolio of game-changing multiplexed potency assays for vaccines and the Cypher One system for digital imaging and automated interpretation of hemagglutination assays. For more information about the company and products, please visit www.indevr.com or call 303-402-9100.
InDevR Chosen for NIH’s Innovation Zone at BIO International Convention
One of select group of NIH SBIR awardees to be featured at BIO
BOULDER COLORADO (4/9/19) — InDevR announced that it has been selected to exhibit and showcase their VaxArray technology at the upcoming BIO International Convention, to be held June 3-6, 2019 in Philadelphia, PA.
Through the Small Business Innovation Research and Small Business Technology Transfer (SBIR/STTR) program, the National Institutes of Health (NIH) has funded many promising technologies and is committed to assisting its grantees/awardees further on their path to commercialization. This year NIH partnered with BIO to provide select SBIR/STTR awardees with premier visibility at the BIO International Convention, providing each company with access to business development executives from around the globe, as well as investors.
InDevR has an extraordinary track record of success for translating scientific ideas into innovative and impactful products. Since its inception InDevR has received three Phase 2 SBIR awards from NIH and successfully translated all three projects into commercial products. For example, development of InDevR’s VaxArray platform, which is now transforming vaccine potency testing, was sponsored through a SBIR grant (R44AI102318) from the National Institute of Allergy and Infectious Diseases, which is part of NIH.
The BIO Convention is the world’s largest biotechnology conference and exhibition, attracting over 16,000 biotech leaders from 72 countries. The Convention covers the wide spectrum of life science innovations and application areas including drug discovery, biomanufacturing, genomics, biofuels, nanotechnology, cell therapy, and more. The key elements of the conference are education, networking, the BIO Exhibition featuring over 1,800 companies, and BIO One-on-One Partnering™, which facilitates more than 45,000 strategic partnering meetings during the three-day event.
This year, there will be a high profile, 6,300 square foot area of the Exhibition floor branded as the Innovation Zone, a turn-key exhibit space dedicated to showcasing 80 NIH SBIR/STTR awardees.
InDevR’s CEO, Dr. Kathy Rowlen, commented “We are keenly aware that Small Businesses account for the majority of all jobs in the U.S., have significant economic impact, and often lead in innovation. The SBIR/STTR program is critical in supporting those efforts, especially for science-driven companies like ours. We are grateful not only for that important R&D funding but for this unique opportunity to communicate the impact of our products within this premier event.”
The content is of this news release is solely the responsibility of InDevR and does not necessarily represent the official views of the NIH.
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.
[Press Release] First Influenza-Specific Neuraminidase Test Kit
InDevR’s game-changing VaxArray® vaccine potency testing platform now includes a reagent kit for rapid assessment of neuraminidase in influenza vaccines
BOULDER COLORADO (6/12/18) — InDevR Inc. announced product release of the first ever commercial reagent kit designed explicitly for assessment of neuraminidase (NA) in influenza vaccines. The new VaxArray kit is poised to help improve influenza vaccines by empowering manufacturers with a standardized method to meet current regulatory requirements and to prepare for future trends. The VaxArray NA kit is also expected to serve as an important new tool in the push for a more broadly protective or “universal” flu vaccine.
The level of neuraminidase (NA) in flu vaccines is not currently regulated but its “presence and type must be confirmed by suitable enzymatic or immunological methods” during vaccine manufacturing. Since no standardized method exists, vaccine producers each implement their own approach and many use non-influenza specific enzymatic activity assays. The VaxArray Influenza Seasonal NA kit is based on N1, N2, and B-NA subtype-specific monoclonal antibodies arrayed for use in a simple, multiplexed immunoassay. The assay is quantitative, highly correlated with enzymatic activity, stability indicating, and has been demonstrated to serve as a proxy for immunogenicity (see Vaccine 36 (2018) 2937–2945).
The VaxArray system has been evaluated by academic leaders who are working toward the ultimate goal of a universal flu vaccine. For example, Prof. Florian Krammer from the Department of Microbiology at the Icahn School of Medicine at Mount Sinai commented:
“The VaxArray system is fast and easy to use. Since it is based on an immunoassay, the results are similar to ELISA in terms of specificity and sensitivity. However, the multiplexed microarray format provides substantially more information and higher throughput than ELISA-based assays. We believe that this system will be a valuable asset in helping us investigate the impact of NA in flu vaccines, including new universal flu vaccines.”
This view was echoed by Dr. Francesco Berlanda Scorza, PATH, Director of Vaccine Development:
“PATH is working toward sustainable production of high-quality, affordable seasonal and pandemic influenza vaccines in developing countries with a focus on new low cost vaccines for children, including innovative broadly protective influenza vaccines. Improving our understanding the role of neuraminidase is an important component of this effort and we welcome advances to specifically measure neuraminidase content in new vaccine candidates. The new VaxArray NA reagent kit has the potential to greatly accelerate this effort.”
Vaccine industry leaders also see a need for better ways to assess the NA content in more traditional flu vaccines. According to Dr. Manon Cox, CEO of Next Wave Bio who led the development of the first recombinant influenza vaccine (Flublok®):
“As articulated by the focus group NAction! in a well-crafted position paper there many outstanding questions about the role neuraminidase in flu vaccines. For example, the level and quality of NA in vaccines can vary dramatically. Thus, one critical sticking point has been the lack of understanding the levels and stability of NA in flu vaccines as no standardized methods for the detection of NA exist. InDevR’s VaxArray assay for NA represents a major breakthrough that will enable unprecedented characterization of NA in both monovalent and multivalent vaccines.”
The VaxArray platform is expected to impact animal influenza vaccines as well. As described by Dr. Ben Hause, Vice President for Research and Development at Cambridge Technologies:
“Advancements in flu vaccines for animals can happen quickly and we understand that neuraminidase could play an important role in enhancing flu vaccine effectiveness. This new potency assay for NA comes at just the right time and provides a much needed standardized method.”
The first VaxArray Influenza Seasonal NA reagent kits are slated to ship on July 1st, 2018 and InDevR is now accepting advance purchase orders. InDevR also offers vaccine potency testing services. Find more information about the entire VaxArray product line at: https://indevr.com/products/vaxarray/