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Horiba received clearance for its Yumizen C1200 CRP reagent used to measure C-reactive protein for evaluation of infections, tissue injury, and inflammatory disorders.
The FDA recently revoked an EUA for Chembio's DPP COVID-19 IgM/IgG system, but the firm said that outside the US, it continues to ship the test and pursue additional opportunities.
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 FDA said that data from the company and an independent evaluation of the test found a higher than expected rate of false results.
The system detects Zika virus IgM antibodies in human serum, potassium-EDTA plasma, potassium-EDTA venous whole blood, or fingerstick whole blood specimens.
Chembio said the agreement with the Fisher Healthcare channel will provide it with expanded access to hospital and physician office labs in the US.
GenMark said it intends to use the proceeds for general corporate purposes that may include an expansion of its menu and increasing its manufacturing capacity.
Although the firm said it refocused its business strategy to address the need for COVID-19 tests in Q1, product sales fell 14 percent year over year.
News items for the in vitro diagnostics industry for the week of April 20, 2020.