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The latest regulatory news and FDA approvals.
The agency confused and upset many in the healthcare community last month when it said asymptomatic patients did not need to be tested.
The test targets antibodies for the viral spike protein and can characterize a vaccine-induced immune response.
Visby's test is a fully integrated PCR device that detects SARS-CoV-2 RNA, while SNIBE's test comprises assays for two different antibodies against the virus.
The test, which received EUA from the US Food and Drug Administration in April, is designed to detect human IgG antibodies in serum and plasma.
The proposed order is intended to give patients more timely access to the tests by moving them from Class III to Class II and providing special controls.
As cases of COVID-19 continued to grow this spring and summer in the US, so too did the number of Emergency Use Authorizations from the FDA for clinical diagnostic tests aimed at detecting current and past infections.