Announcement

Boston Molecules has finalized the configuration of its ZyaltTM COVID-19 IgM&IgG DR TEST kit, and will commence scaled up production as soon as the FDA Emergency Use Authorization (EUA) is granted. The DR (double rapid) TEST device employs a simple, easy-to-use method to detect the presence of human IgG and IgM antibodies in blood, plasma or serum samples, which could reveal the history of SARS-CoV-2 exposure. Boston Molecules has been granted manufacturer operator number 10070123 and registration number 3016734013 by FDA for this device. Tests on clinical samples (212 in total) show 96% PPA (positive percent agreement) and 100% NPA (negative percent agreement) with nucleic acid qPCR tests. Boston Molecules has provided test kits to Fulgent Genetics Inc., California for further clinical trials, and to rule out cross-reactivity with antibodies resulting from previous infections by other types of coronavirus. A highly automated robotic production line aimed at the monthly production of millions of test kits is on Boston Molecules’ agenda.