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GeneFirst Gets CE-IVD Mark for Coronavirus, Flu, RSV Combo Test Kit

NEW YORK — UK molecular diagnostics firm GeneFirst said on Tuesday that it has received CE-IVD marking for its COVID-19 Plus Detection Kit for the detection of SARS-CoV-2, influenza A/B, and respiratory syncytial virus.

The test kit, which provides results in under two hours, is PCR system-agnostic and is suitable for use with a range of instruments including Roche's LightCycler, and Thermo Fisher Scientific's Applied Biosystems 7500, according to a GeneFirst spokesperson.

The spokesperson added that the COVID-19 Plus Detection Kit is now available is Europe and Asia, and that GeneFirst expects to seek Emergency Use Authorization from the US Food and Drug Administration for the test in 2021.

GeneFirst is also leading a consortium called RAPID-COVID, funded with €2.8 million ($3.4 million) from Europe's Innovative Medicines Initiative, that is developing a diagnostic kit for the detection of SARS-CoV-2 plus 30 other common respiratory bacterial and viral pathogens, the spokesperson said. The test will be designed for point-of-care and laboratory use.