August 19, 2020
Assistant Secretary for Health Admiral Brett P. Giroir, M.D., Statement on FDA EUA for LumiraDx UK Ltd.’s - LumiraDx SARS-CoV-2 Antigen Test
This week the U.S. Food and Drug Administration granted an Emergency Use Authorization (EUA) for LumiraDx UK Ltd.’s LumiraDx SARS-CoV-2 Ag Test. LumiraDx is a rapid point-of-care antigen test at is used with the LumiraDx Platform for the detection of SARS-CoV-2 directly from nasal swab specimens. In response, Assistant Secretary for Health and COVID-19 Testing Coordinator Admiral Brett P. Giroir, M.D., issued the following statement:
“LumiraDx Platform is a novel, flexible, highly scalable and low cost rapid point-of-care test that will significantly contribute to our scaling up and expanding testing platforms for SARS-CoV-2. This technology has built-in digital connectivity, almost everything we hope for in new testing platforms coming to market. Furthermore, its flexibility to perform diagnostic assays to detect indicators of various diseases, including inflammatory markers, could be transformative in providing improved access to quality health care.”
The LumiraDX SARS-CoV-2 Ag Test is for use within the first 12 days of the onset of symptoms consistent with COVID-19 by laboratories certified under the Clinical Laboratory Improvement Amendment (CLIA) to perform moderate, high or waived complexity tests and for use at the point-of-care (i.e., patient care settings) operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation.