News and analysis on diagnostic technologies and applications.
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.
The tests will be developed to identify NSCLC patients with ALK fusions and EGFR Exon20 insertion mutations who respond to mobocertinib or brigatinib.
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.
