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November 8, 2021

Coronavirus company news summary – FDA clears iHealth Covid-19 lateral flow test for home use – German Medical Association president calls for return of free Covid-19 testing

By Chris Lo

The US Food and Drug Administration (FDA) has granted Emergency Use Authorization (EUA) for the over-the-counter sale of iHealth Labs’ Covid-19 Antigen Rapid Test. The lateral flow assay can qualitatively identify the nucleocapsid protein antigen from the SARS-CoV-2 virus. Indicated for those aged two years and above who are symptomatic or as a serial test for asymptomatic people, the at-home self-test offers results in 15 minutes. iHealth can currently manufacture 100 million tests monthly and anticipates boosting capacity to 200 million starting from January 2022.

German Medical Association president Klaus Reinhardt has urged Germany’s federal and state authorities to quickly reinstate free Covid-19 testing as the country is witnessing a surge in cases, Deutsche Welle reported. To get more people vaccinated, free Covid-19 tests were phased out in October. According to Reinhardt, this strategy is not working, and he has urged a stringent requirement to allow only those vaccinated or recovered from Covid-19 to attend events or enter public places.

Scientists at the University of California San Diego in the US have developed a quick diagnostic technology that can identify the SARS-CoV-2 virus. Leveraging CRISPR gene-editing technology, the novel sensitive enzymatic nucleic acid sequence reporter (SENSR) permits quick identification of pathogens by recognising the genetic sequences in their DNA and RNA. The team noted that SENSR can potentially streamline the Covid-19 detection process and could be modified for usage in the at-home setting. SENSR demonstrated an ability to identify the SARS-CoV-2 virus in under one hour in previous tests.

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