Joining a growing number of diagnostics companies mobilizing to minimize the spread of monkeypox, Novacyt SA and Seegene Inc. reported they have developed new polymerase chain reaction (PCR) assays to quickly diagnose the disease this week. Roche Holding AG released three monkeypox tests for research use in late May. Abbott Laboratories and Becton Dickinson & Co. have similar plans. Stanford Medicine made its own diagnostic available to its patients last week.
Non-clinical testing for the SARS-CoV-2 virus has been a major goal for regulators across the globe for months. Emergency use authorization (EUA) was just granted by the FDA is for the Quidel Quickvue COVID-19 test, an at-home antigen test with a turnaround time of 10 minutes. It’s the latest in a series of approvals of home tests and collection kits that promises to help control the pandemic.
PARIS – In the wake of the news that Swiss group Roche Holding AG received an emergency use authorization from the U.S. FDA as well as a CE-IVD certification for the Elecsys Anti-SARS-CoV-2 serology test to detect antibodies in people previously exposed to SARS-CoV-2 that causes the COVID-19 disease, the company unveiled its plans for the launch of the product.