Coronavirus company news summary - FDA grants EUA to BioGX’s Covid-19 RT-PCR test - Alaska Airlines and AZOVA partner to offer Covid-19 home tests - Verdict Medical Devices
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Coronavirus company news summary – FDA grants EUA to BioGX’s Covid-19 RT-PCR test – Alaska Airlines and AZOVA partner to offer Covid-19 home tests

02 Jul 2021

BioGX has sought Emergency Use Authorization (EUA) from the US Food and Drug Administration (FDA) for its Xfree Covid-19 test. The test is lyophilised in a single tube for extraction-free, direct sample addition real-time RT-PCR testing. It thereby removes all sample processing steps and enables clinical laboratories to generate high-throughput sample-to-answer results using real-time PCR platforms.

LumiraDx has achieved a CE mark for its RNA STAR Complete SARS-CoV-2 test. The test was initially granted EUA by the US FDA in October 2020 and re-issued the same in March 2021. The LumiraDx RNA STAR Complete SARS-CoV-2 test enables laboratories to quickly adopt and support their testing programmes inside and outside, such as mobile lab units that offer easy access to testing wherever required.

AZOVA, a digital health technology system, and Ellume, a medical technology manufacturer, have entered into a partnership with Alaska Airlines to offer a convenient, at-home rapid testing solution for its travellers. The Ellume Covid-19 home test and AZOVA video observation service allow Alaska Airlines travellers to test themselves and receive accurate results, while at the same time sharing the test results and vaccination status via their smartphone.