RenegadeXBio, PBC developed the renegadeXP™ SARS-CoV-2 (COVID-19) polymerase chain reaction (PCR/RT-PCR/qPCR) viral nucleic acid detection assay (NAA). The renegadeXP™ and CDC tests are permitted and authorized, respectively, during the current emergency declaration in which circumstances exist justifying the authorization of the emergency use of in vitro diagnostic tests for detection of SARS-CoV-2 virus and diagnosis of COVID-19 infection under section 564(b)(1) of the Act, 21 U.S.C. 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.
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*The Clinical Laboratory Improvement Amendments of 1988 (CLIA) regulations include federal standards applicable to all U.S. facilities or sites that test human specimens for health assessment or to diagnose, prevent, or treat disease. The CDC, in partnership with CMS and FDA, supports the CLIA program and clinical laboratory quality.