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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.
Some parts of Europe turned to serology testing early to try to get a handle on the pandemic but had to quickly pull back after those tests performed abysmally.
Sema4 said it will provide SARS-CoV-2 viral and antibody testing to Connecticut residents including state employees and first responders.
Webb Diagnostic has placed an initial order worth about C$3.5 million for MedMira's RevealCOVID-19 Total Antibody Test.
The Dutch firm announced a deal earlier in the month to develop the test with Duke-NUS Medical School and the Diagnostics Development Hub in Singapore.