Boulder, CO – June 17, 2020– InDevR, Inc., a leader in novel analytical technologies that support the development and production of vaccines and biotherapeutics, announced commercial availability of its COVID-19 serology test kits. InDevR’s VaxArray Coronavirus SeroAssay leverages the Company’s established VaxArray platform to deliver a rapid quantitative test that can simultaneously screen for antibody responses to the spike proteins of SARS-CoV-2, SARS-CoV-1, MERS, and all four endemic coronaviruses in both animal and human samples. The serological test kit is designed to streamline development of SARS-CoV-2 vaccine candidates by enabling measurements of pre-immunization status of clinical study participants, post-immunization antibody levels, and any potential induced cross-protection against other coronaviruses. The VaxArray Coronavirus SeroAssay uses ~200x less antigen per test than a typical ELISA, which is critical during a time when supplies of antigens are limited.
Based on a clinical validation study involving over one hundred specimens and conducted in collaboration with Children’s Hospital in Denver, the assay exhibits 100% clinical specificity and 98% sensitivity. Quantitative results with low limits of detection and multiple answers from a single <10 µL aliquot is more imformative. This new tool will undoubtedly enable higher quality research and provide a deeper understanding of immunity. InDevR also offers Testing Services to alleviate additional vaccine development bottlenecks
Kathy Rowlen, CEO of InDevR, further noted that “In addition to the improvements in speed, usability, and information content relative to traditional ELISA immunoassays, we believe our VaxArray CoV SeroAssay can be used as a standardized benchmarking tool for the many organizations pursuing SARS-CoV-2 vaccine candidates. Higher quality comparisons of baseline antibody levels and immune responses across thousands of clinical study samples collected during the coming months will help accelerate the identification of the most promising vaccine candidates.”
“The InDevR Coronavirus SeroAssay helped us to rapidly gain insight into various formulations of our COVID-19 vaccine candidates, providing us with an understanding of IgG response to SARS-CoV2 spike antigen produced from various sources and cross reactivity with other CoVs. The information provided from the assay helped to guide decisions in our continuing work on development of a SARS-CoV-2 candidate vaccine. We found the correlation with our microneutralization measurements interesting and we look forward to pursuing this link further” noted Kentucky BioProcessing President, Hugh Haydon.
The VaxArray CoV SeroAssay is based on InDevR’s VaxArray platform, a microscale multiplexed immunoassay that is already used by the world’s largest vaccine manufacturers to streamline development and characterization of seasonal influenza vaccines, with applications to a range of other vaccines currently under development in collaboration with the Bill & Melinda Gates Foundation. The portfolio of VaxArray products delivers highly-sensitive and quantitative measurements in a fraction of the time required for traditional characterization methods, thus reducing vaccine development timelines and manufacturing costs.
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About InDevR—Based in Boulder, CO, InDevR is a biotechnology company poised to significantly impact vaccine process optimization and manufacturing with powerful new protein characterization tools. With a strong history of non-dilutive funding raises, including a $14.7M BARDA contract to develop a high information content influenza diagnostic, plus a recent investment from the Bill & Melinda Gates Foundation to advance measles and rubella vaccine characterization, InDevR has launched several successful life science tool-based product lines including VaxArray and Cypher One.