Sard Verbinnen & Co. represents Premier Biotech, which today received emergency use authorization from the US Food & Drug Administration to distribute a COVID-19 antibodies test manufactured by China's Hangzhou Biotest Biotech. The product produces results in 10 minutes.
Todd Bailey, Premier CEO called the FDA's decision "great news for communities across the U.S. that continue to struggle to access adequate COVID-19 testing, which healthcare experts agree is essential to successful recovery from the COVID-19 crisis."
The emergency use authorization confirms the National Cancer Institute's research that found the product exceeds the 95% specificity and 90% sensitivity standards set by the FDA.
Bailey said Premier would continue to follow regulatory guidelines closely as it distributes the test kit for emergency use to authorized laboratories through the US.
Sard Verbinnen's Lindsay Charles represents Minneapolis-based Premier Biotech.