FDA Emergency Use Authorization
The LYRA SARS-CoV-2 assay is a real-time RT-PCR assay intended for the in vitro qualitative detection of human coronavirus SARS-CoV-2 from viral RNA extracted from nasal, nasopharyngeal (NP) or oropharyngeal (OP) swab specimens from patients with signs and symptoms of COVID-19. The assay targets the non-structural polyprotein (pp1ab) of the SARS-CoV-2 virus. The authorized testing consists of nucleic acid extraction on the bioMerieux NucliSENS® easyMAG® system or EMAG system, followed by RT-PCR on one of six thermocyclers: Applied Biosystems® 7500 Fast Dx, Applied Biosystems 7500 Standard, QuantStudioTM Real-Time PCR Instrument, Roche LightCycler® 480, BioRad CFX96 Touch, or Qiagen Rotor-Gene Q.
The LYRA SARS-CoV-2 Assay has not been FDA cleared or approved but has been authorized by the FDA under an Emergency Use Authorization (EUA) for use by authorized laboratories for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens. This assay is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless authorization is terminated or revoked sooner.
FDA Emergency Use Authorization
The LYRA SARS-CoV-2 assay is a real-time RT-PCR assay intended for the in vitro qualitative detection of human coronavirus SARS-CoV-2 from viral RNA extracted from nasal, nasopharyngeal (NP) or oropharyngeal (OP) swab specimens from patients with signs and symptoms of COVID-19. The assay targets the non-structural polyprotein (pp1ab) of the SARS-CoV-2 virus. The authorized testing consists of nucleic acid extraction on the bioMerieux NucliSENS® easyMAG® system or EMAG system, followed by RT-PCR on one of six thermocyclers: Applied Biosystems® 7500 Fast Dx, Applied Biosystems 7500 Standard, QuantStudioTM Real-Time PCR Instrument, Roche LightCycler® 480, BioRad CFX96 Touch, or Qiagen Rotor-Gene Q.
The LYRA SARS-CoV-2 Assay has not been FDA cleared or approved but has been authorized by the FDA under an Emergency Use Authorization (EUA) for use by authorized laboratories for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens. This assay is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless authorization is terminated or revoked sooner.
