FDA Establishes Additional Conditions Of Emergency Use Nod For COVID-19 Tests For Viral Mutations
The FDA has issued a letter to establish additional conditions of Emergency Use Authorizations (EUAs) manufacturers of COVID-19 tests.
The agency has asked COVID-19 test manufacturers to assess the impact of SARS-CoV-2 viral mutations on the performance of their products.
Related: FDA Warns On Potential False Positive Results With Abbott's COVID-19 Lab Tests.
The request applies to molecular, antigen, and serology tests and is part of a set of extra FDA emergency use nod conditions.
FDA's order comes amid renewed focus on COVID-19 testing as Delta variant has spiked the demand after a lull period seen during early 2021.
Manufacturers must include any additional data analysis requested by FDA and be prepared to submit records of their assessments to the agency within 48 hours of being asked to do so.
The agency also expects manufacturers to update their labeling within seven days to include any additional labeling risk mitigations identified by the FDA regarding the impact of viral mutations on test performance.
All manufacturers now need to update their labels with the information provided by FDA in the updated EUA conditions within three months.
Last month, the FDA granted emergency use authorization to two Thermo Fisher Scientific Inc (NYSE: TMO) COVID-19 assays designed to "compensate" for current mutations and emerging SARS-CoV-2 variants.
Over the past week, the U.S. government ordered more than $1 billion worth of rapid tests from Abbott Laboratories (NYSE: ABT) and Celltrion.
The Department of Defense has awarded $647 million to a handful of suppliers of OTC kits, including Quidel Corporation (NASDAQ: QDEL) and OraSure Technologies Inc (NASDAQ: OSUR).
The DoD contracts cover 60 million tests that will be delivered from October to September 2022.
Related: OraSure Secures 5M Contract For OTC COVID-19 Tests.
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