Detectachem Inc. has scored an emergency use authorization (EUA) from the U.S. FDA to market a new molecular RNA test kit for SARS-CoV-2 that provides color-coded results in about 30 minutes.
While the emergency use authorization (EUA) the FDA granted Aug. 23 for convalescent plasma remains a political talking point, the agency moved ahead Sept. 2, issuing an updated, immediately effective guidance on the use of convalescent plasma to treat COVID-19 patients in ongoing clinical trials, on an expanded access basis or under the EUA.
As the COVID-19 pandemic continues into the fall, Roche Group is planning to launch its latest tool later this month. And while its SARS-CoV-2 Rapid Antigen Test will be available in markets accepting the CE mark, the company is expecting the filing for emergency use authorization (EUA) from the U.S. FDA. Roche’s test is a rapid chromatographic immunoassay intended for the qualitative detection of a specific antigen of SARS-CoV-2 present in human nasopharynx.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Biohit, Cardiac Dimensions, Detectachem, Exsomed, Pq Bypass, Tissue Regeneration Technologies.
As 2020 approaches its last quarter, scientists around the globe continue their all-consuming efforts to find effective therapeutics and vaccines to fight the deadly COVID-19 pandemic, which currently has a 3.35% fatality rate and has been plaguing the world for more than half a year. While the fight rages on, people are growing weary of political posturing and community debates. They face a serious conundrum of how to best protect those vulnerable to the virus, while still considering the psychological and economic impacts of societal lockdowns.
