Because the 2019 novel coronavirus outbreak was so unanticipated, there were no FDA-approved commercial products for it available in the US during its early days. On Jan. 28, the FDA unveiled its strategy for promoting the rapid development and availability of safe and effective investigational medical products “to address this urgent public health situation.” As with previous infectious disease outbreaks like Zika, the centerpiece of the FDA strategy is expedited clearance of new coronavirus tests and treatment products via the Emergency Use Authorization (EUA) pathway. The FDA called on diagnostic test sponsors interested in potential EUA for detection tests to contact the Center for Devices and Radiological Health (CDRH) (CDRH-EUA-Templates@fda.hhs.gov) for information and templates. The CDC Test On Feb. 4, the agency took the first step by issuing an EUA for a reverse transcriptase real-time PCR (rRT-PCR) assay (aka, the 2019 Real Time RT-PCR Diagnostic Test Panel) developed by the US Centers for Disease Control and Prevention (CDC) for use in detecting coronavirus from respiratory and blood serum samples, including nasal or oral swabs. The test can be used in the US only by CDC-designated laboratories that are certified to perform high-complexity testing in accordance with agency protocol. The CDC published the […]