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Los Angeles Company Falsely Announces FDA Authorization for Two-Minute COVID-19 Diagnostic Test



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On Tuesday morning, Los Angeles-based Bodysphere announced that it had received an Emergency Use Authorization (EUA) for a rapid COVID-19 serology test able to deliver results in as little as two minutes.
Word of the company product spread quickly across social media and several mainstream news publications, which highlighted the platform’s quick turnaround time, and the impact that such a test could have on identifying those who should or should not self-quarantine.
However, Bodysphere’s test was never acknowledged on the FDA’s running list of in vitro diagnostic products that have received an EUA. Other news outlets that had reached out to the FDA for confirmation of the authorization received statements clarifying that the agency has not yet issued an EUA to any serology diagnostics for COVID-19.
Within a single day, Business Wire – a platform that uploads and disseminates press releases to media – pulled Bodysphere’s announcement from its service, and several news outlets amended or fully retracted their coverage of the test. The company itself has since posted a statement from its CEO, Charlton E. Lui, describing the confusion as a misunderstanding on the part of Bodysphere.
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