All other COVID-19 tests in use have received emergency use authorizations, meaning they would not be eligible to be used once COVID-19 is no longer declared a public health emergency.
The test is made by BioFire Diagnostics, a Salt Lake City-based diagnostics company. It is a nasal swab test used to detect multiple respiratory viruses, including COVID-19.
The test is approved to test only symptomatic people suspected of having COVID-19 or another respiratory tract infection.
“While this is the first marketing authorization for a diagnostic test using a traditional premarket review process, we do not expect this to be the last, and look forward to working with developers of medical products to move their products through our traditional review pathways,” acting FDA Commissioner Janet Woodcock said in a news release.
Read the FDA’s full news release here.
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