InDevR, Inc., a leader in progressive analytical technologies to support the development and production of vaccines and biotherapeutics, announced shipment of its first COVID-19 serology test kits this week for clinical validation. InDevR’s VaxArray Coronavirus SeroAssay is a microscale multiplexed immunoassay that leverages the Company’s established VaxArray platform to deliver a rapid, off-the-shelf test that can simultaneously screen for antibody responses to the spike protein of SARS-CoV-2, SARS-CoV-1, MERS, and other endemic coronaviruses. The serological test kit is designed to streamline development of SARS-CoV-2 vaccine candidates and to aid in seroprevalence studies for SARS-CoV-2. InDevR expects validation to take approximately 2-4 weeks and intends to have kits ready for commercial use by early May 2020.
Through an on-going collaboration with Kentucky BioProcessing (“KBP”), the first VaxArray CoV SeroAssay kits will be evaluated in pre-clinical studies for KBP’s SARS-CoV-2 vaccine candidate, which is based on a proprietary fast-growing tobacco plant vaccine platform. KBP’s platform was used to generate a SARS-CoV-2 vaccine candidate within four weeks of publication of the genetic sequence. “This is an ideal partnership,” commented Kathy Rowlen, CEO of InDevR. “KBP’s rapid vaccine manufacturing platform requires equally rapid and efficient analytical tools and we couldn’t be more pleased that KBP has adopted the VaxArray technology.”
“InDevR is at the forefront of streamlining serology testing that could directly impact the development of a COVID-19 vaccine as well as detection of antibodies to help determine whether an individual has previously been infected,” noted KBP President, Hugh Haydon. “Their cutting-edge work makes it easier for developers to quantify antibodies of COVID-19 and thus speed development of a vaccine. We’re proud of our productive relationship with InDevR. Whether it is our own or another vaccine, we hope that our role in this collaboration helps to speed up development of vaccines and other tools to fight this virus.”
The VaxArray CoV SeroAssay is based on InDevR’s VaxArray platform, a microscale multiplexed immunoassay that is already being used by several of 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.
Kathy Rowlen, 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 kits can be used as a standardized benchmarking tool for the many organizations pursuing SARS-CoV-2 vaccine candidates, allowing apples-to-apples comparisons of baseline antibody levels and immune responses across the thousands of clinical study samples that will be collected in the coming months. Better comparability of serology data across vaccine candidates may help accelerate the identification of the most promising approaches.”
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 and 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.
KBP is located in Owensboro, Ky., where it began operations in 2006. In January 2014, KBP was acquired by and became an independently operated, wholly-owned subsidiary of Reynolds American Inc. (RAI), a British American Tobacco Group Company. KBP continues to house its large, multilevel indoor plant-growth space, as well as its research and production laboratories, clean rooms and manufacturing operations in Owensboro. KBP made headlines in 2014 for its role developing the Ebola treatment, ZMapp™ in collaboration with California-based company Mapp BioPharmaceutical and the U.S. Biomedical Advanced Research and Development Authority (BARDA).