FDA Gives Emergency Use Authorization To COVID-19 Test That Produces Results In Under 12 Minutes

The Food and Drug Administration has given emergency use authorization to LumiraDx for its COVID-19 antigen test, which provides COVID-19 test results in under 12 minutes.

The SARS-CoV-2 antigen test detects nucleocapsid proteins from a nasal swab that is inserted into the nasal cavity, offering fast and cost-efficient COVID-19 test results, LumiraDx said.

The Massachusetts-based diagnostics company also said the test demonstrated a 97.6% positive agreement compared to PCR — a DNA laboratory technique — in patients that tested within 12 days of coronavirus symptoms.

LumiraDx said the tests will begin shipping by the end of August, with plans to produce 2 million tests in September. The company expects to ramp up to 10 million tests in December.

“Now that the FDA EUA has been received, we are working with health systems, major retail clinics, and employers to get our platform to healthcare providers quickly to utilize in their testing programs,” LumiraDx CEO Ron Zwanziger said in a statement

The test is the third antigen test that has been given emergency use authorization by the FDA. The agency said the test is authorized for use in laboratories certified under the clinical laboratory improvement amendments as well as inpatient care settings that operate under a clinical laboratory improvement amendments’ certificate of waiver, certificate of compliance, or certificate of accreditation.