CAP TODAY Pathology/Laboratory Medicine/Laboratory Management
January 2022—LumiraDx announced a partnership with digital health nonprofit Audere to offer a COVID-19 nasal specimen collection kit that has been authorized for use with the LumiraDx SARS-CoV-2 RNA Star Complete assay to process self-collected samples. SARS-CoV-2 RNA Star Complete has received FDA emergency use authorization for use by authorized laboratories. Laboratories using SARS-CoV-2 RNA Star Complete will be able to integrate Audere’s HealthPulse@home into their systems.
By following HealthPulse@home authorized labeling instructions, CLIA-certified labs can customize and rebrand HealthPulse@home to bring their own specimen collection kit to market without completing all of the steps required to obtain FDA EUA.
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