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While the market ditched shares of many other diagnostics firms, analysts said the reaction was overblown, particularly in the case of Quidel and molecular diagnostics players.
The firm said that its financial results for the second quarter of 2020 reflected the impact of an FDA revocation of an EUA for its DPP COVID-19 IgM/IgG System.
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.