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LumiraDx Gets CE Mark for Point-of-Care COVID-19 Testing Instrument

NEW YORK — UK-based diagnostics firm LumiraDx said on Thursday that it has received CE marking for its Amira Analyzer, a portable instrument for rapid COVID-19 testing.

The instrument is designed to read Amira SARS-CoV-2 Ag test strips, which detect viral antigens in roughly 15 minutes. LumiraDx said that the CE mark covers professional use of the test at the point of care, but that it intends to seek additional regulatory approvals and authorizations to expand use to nonprofessionals and at home without a prescription.

Earlier this week, LumiraDx received CE marking for a molecular SARS-CoV-2 test and an assay that tests for both SARS-CoV-2 and influenza virus.