Coronavirus company news summary - Applied DNA’s LineaTM Covid-19 Assay Kit receives EUA - US FDA grants EUA to QIAGEN’s Covid-19 antibody test - Verdict Medical Devices
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Coronavirus company news summary – Applied DNA’s LineaTM Covid-19 Assay Kit receives EUA – US FDA grants EUA to QIAGEN’s Covid-19 antibody test

13 May 2021 (Last Updated May 13th, 2021 10:00)

Applied DNA Sciences has announced that its Linea Covid-19 Assay Kit has been re-issued Emergency Use Authorization (EUA) by the US Food and Drug Administration (FDA) to include asymptomatic screening of individuals via serial testing. The expanded intended use allows for screening individuals with or without symptoms, reduces prescription time, and returns results directly to individuals. The test is now available for immediate purchase by Clinical Laboratory Improvement Amendments (CLIA)-certified laboratories across the country.

Qiagen has been granted EUA by the US FDA for its digital QIAreach Anti-SARS-CoV-2 Total Test. The authorisation allows the company to provide its portable antibody testing device to all healthcare professionals in the US. One antibody test takes about 10 minutes to identify the presence of antibodies in individuals against the SARS-CoV-2 virus as a result of a prior infection. The test results are read on a digital eHub device capable of processing up to 32 tests every hour.

WhenToTest.org, an online platform that supports Covid-19 mitigation strategies, announced that it has collaborated with the Arizona State University (ASU) and Project N95 to enable organisations to remain open or resume operations, by facilitating the provision of Covid-19 diagnostic tests in small or large numbers from approved suppliers.