COVID-19: FDA Anticipates Further Serology Test Development
US FDA staff discussed hopes for additional serology and saliva tests for COVID-19, as well as at-home test options, during a 15 April webinar.
You may also be interested in...
The US agency’s decision to allow developers to distribute tests that detect COVID-19 in human blood without going through a clearance process has led to some misleading marketing, the agency warned in two recent statements.
While US regulators have ramped up the number of authorizations they’ve granted to companies on an emergency basis in response to the COVID-19 crisis, they really kicked things into high gear in just the past few days. On 10 April the agency issued a record number of EUAs in response to the pandemic.
The US FDA is open to the idea of home-testing for the COVID-19 virus, but only after making sure the test is completely safe and effective, and available only through a physician’s oversight, said Tim Stenzel, director of the agency’s Office of In Vitro Diagnostics and Radiological Health.