BARDA and InBios International, Inc. are collaborating on the rapid development of the SCoV-2 Ab Detect™ Rapid Test as a point-of-care assay (test) to detect SARS-CoV-2 reactive antibodies in a blood samples.
The SCoV-2 Ab Detect™ Rapid Test will be a lateral flow “serodiagnostic” test, using blood products, including from a finger prick, to identify people infected with SARS-CoV-2, the virus that causes COVID-19 disease. By looking for an immune response to the virus, serology tests help healthcare providers and public health officials better quantify the number of cases of COVID-19 in the country, including among people who may not show symptoms or who have recovered.
In order to make the test more widely available, the company will acquire reagents, including patient samples, and will produce kits for, and carry out performance studies to validate the assay design in order to request Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA). Making these tests available would increase U.S. testing capacity and help combat the current pandemic.
An EUA submission package will follow the FDA pre-EUA template and will include a proposed intended use statement, study performance data, and a draft package insert. A final EUA package submission is expected within 6 months of this award.
This award is one component of BARDA’s rapidly expanding COVID-19 medical countermeasure portfolio; visit BARDA’s COVID-19 Portfolio to learn more.
About the Company:
The following information is provided by the company and does not indicate endorsement by the federal government of the company or its products.
InBios International Inc. specializes in the design, development and manufacture of diagnostic devices for emerging infectious diseases and biothreats. Founded in 1996 in Seattle, WA, our superior quality products are accurate, easy to use and cost effective. InBios offers an extensive catalog of life science reagents, along with a portfolio of more than 25 diagnostic products, including FDA-cleared ELISA kits for Zika, dengue, and West Nile and rapid test kits for Chagas and leishmaniasis. InBios is GMP compliant, FDA registered, USDA licensed and ISO 13485:2016 certified.