The U.S. Food and Drug Administration has granted emergency use authorization (EUA) for a SARS-CoV-2 diagnostic test that analyzes breath samples as well as a genotyping test authorized for the identification and differentiation of SARS-CoV-2 Phylogenetic Assignment of Named Global Outbreak (PANGO) lineages.
The EUAs were issued for each individual test with certain conditions of authorization required of the manufacturer and the settings required for use of the test.
The InspectIR COVID-19 Breathalyzer was authorized for use on April 14, 2022. It can be used to test exhaled breath from individuals 18 years and older with or without symptoms or other epidemiological reasons to suspect COVID-19. Use of the InspectIR COVID-19 Breathalyzer is restricted to qualified, trained personnel working under the direction of a medical professional who is licensed or permitted by state law to order tests. Additionally, it is only permitted to be used in settings where patient specimens are collected and analyzed.
The FDA granted EUA on June 10, 2022, to the Labcorp VirSeq SARS-CoV-2 NGS Test, a next-generation sequencing test on the PacBio Sequel II sequencing system, designed for the identification and differentiation of SARS-CoV-2 PANGO lineages from SARS-CoV-2-positive samples discovered using the Labcorp COVID-19 RT-PCR Test or Labcorp SARS-CoV-2 & Influenza A/B Assay.
Sources:
https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-authorizations-medical-devices/in-vitro-diagnostics-euas-other-tests-sars-cov-2
