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December 17, 2021updated 07 Jan 2022 8:47am

Coronavirus company news summary – FDA grants EUA to Applied BioCode’s combined Covid-19/flu/RSV test – Three Covid-19 tests fail to identify Omicron variant, FDA finds

By Kezia Parkins

The US Food and Drug Administration (FDA) has granted Emergency Use Authorization (EUA) to Applied BioCode’s multiplex molecular diagnostic assay for Covid-19 flu and Respiratory Syncytial Virus detection. The BioCode CoV-2 Flu Plus Assay can identify and distinguish between the SARS-CoV-2, Influenza A with subtypes RSV from nasopharyngeal swab samples. Intended to aid doctors in assessing individuals with clinical signs and symptoms of respiratory infection, this PCR test is the third test of the company to receive FDA EUA for Covid-19.

Ethos Laboratories has introduced its Tru-Immune, a self-collectable fingerstick kit for its Covid-19 neutralising antibody test offering quantitative data on the viral blocking ability neutralising antibodies. This test aids people to get immunity levels against Covid-19 rapidly and efficiently in real-time with minimum discomfort. Tru-Immune requires a simple drop of capillary blood from the fingertip and delivers results electronically in 48 hours.

The US Food and Drug Administration (FDA) has found that three Covid-19 molecular tests failed to identify the Omicron variant of the SARS-CoV-2 virus. The impacted tests are Revogene SARS-CoV-2 of Meridian Bioscience, Tide Laboratories’ DTPM COVID-19 RT-PCR Test and Linea COVID-19 Assay Kit of Applied DNA Sciences. The regulatory agency has advised halting the usage of these tests until the issues are addressed.

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