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November 2, 2021

Coronavirus company news summary – FDA expands EUA of LumiraDx’s SARS-CoV-2 test for asymptomatic people – Cue Health offers molecular Covid-19 testing platform to MLB clubs

By Chloe Kent

The US Food and Drug Administration (FDA) has expanded the Emergency Use Authorization (EUA) for the LumiraDx SARS-CoV-2 Antigen Test to incorporate testing of asymptomatic people. The test was formerly intended exclusively for use in people suspected to have Covid-19 by a healthcare professional within 12 days of symptom development. The EUA expansion is based on the latest data from asymptomatic individuals which showed the test had a positive and negative agreement of 82.1% and 100%, respectively, with an RT-PCR test.

The FDA has granted authorisation for pooled saliva sampling using the Yale School of Public Health SalivaDirect PCR COVID-19 test. Yale-approved labs can now utilise the test to pool up to five saliva samples at once for testing. The test is intended to be used for routine checking of asymptomatic people or for those suspected of having Covid-19. Adult users can obtain samples in the presence of a trained professional or in an at-home setting using the SalivaDirect Unsupervised Collection Kit or SalivaDirect At-Home Collection Kit.

Cue Health is offering its integrated Cue platform to all the Major League Baseball (MLB) clubs and the league office during the Postseason and World Series. The molecular diagnostic platform comprises the portable Cue Health Monitoring System and Cue COVID-19 tests. The platform can provide results straight to smartphones in just 20 minutes. It is the first-ever molecular diagnostic test to obtain FDA authorisation for use without needing the supervision of a doctor or a prescription.

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