TORONTO – Toronto-based Sqi Diagnostics Inc. has reported significant clinical progress developing three novel COVID-19 tests for submission for U.S. FDA emergency use authorization.

The U.S. FDA has granted emergency use authorization (EUA) to Genscript USA Inc. for its Cpass SARS-CoV-2 Neutralization Antibody Detection Kit, the first commercially available test to detect neutralizing antibodies in individuals previously infected with the novel coronavirus. The serology test measures levels of neutralizing antibodies in samples from patients recovering from COVID-19 as well as people vaccinated against the SARS-CoV-2 virus.

The U.S. FDA has given its nod to a new solution that aims to help with the temporary reduction of sleep disturbance related to nightmares in certain people. Specifically, the agency reviewed the device, from Minneapolis-based Nightware Inc., through the de novo premarket review pathway and now is permitting its use in patients aged 22 years of age or older who are suffering from nightmare disorder or have nightmares from post-traumatic stress disorder (PTSD). The agency previously granted the solution breakthrough device designation.