This test is a modification of the FDA EUA-authorized assay, CDC 2019 Novel Coronavirus (2019-nCoV) Real-Time RT-PCR Diagnostic Panel. The modification is validated using a bridging study and is permitted under the FDA modifications policy in the Policy for Coronavirus Disease-2019 Tests. The bridging study was performed by lntegrated Molecular Diagnostics Pathology, Inc. (IMD Path), 12635 E. Montview Blvd., Suite 360, Aurora, CO 80045. This test has not been cleared or approved by the FDA, however, such clearance/approval is not required, as the laboratory is regulated and qualified under the Clinical laboratory Improvements Amendments (CLIA) to perform high-complexity clinical laboratory testing. This test is used for clinical purposes and should not be regarded as investigational or for research use.