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The firm delivered record revenue and the most profitable quarter in its history as a result of the increased demand for its products.
According to Snibe, the test has 99.6 specificity and 100 percent sensitivity at 15 days following the onset of symptoms for COVID-19.
Unilabs Denmark, the local subsidiary of the European diagnostic services provider, will carry out antibody testing as part of the effort.
Data generated via the platform will be used to inform UK National Health Service policy.
Chembio suggested a device modification could improve performance, following an analysis of troubling NCI data. The FDA didn't agree.
The warning letters may signal increased vigilance from the FDA against firms offering coronavirus antibody tests that it believes could harm consumers.
The firm expects to launch a tissue-based immunohistochemistry version of the test, which detects QSOX1, in mid-2021, followed by a dipstick plasma-based assay by early 2022.
Menarini said the test, which detects IgG and IgM antibodies, is available in the US based on receipt of an FDA EUA by its manufacturer, Healgen Scientific.
The firm developed the total antibody test for use on its Dimension analyzers alongside its development for its Advia Centaur and Atellica analyzers.
Quidel received funding to develop a four-analyte antigen test to run on the firm's Sofia 2 point-of-care multiplex platform.