FDA Authorizes Quidel’s Molecular COVID-19 Diagnostic Assay

Quidel Corporation, a provider of rapid diagnostic testing solutions, cellular-based virology assays, and molecular diagnostic systems, has received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) to market its Lyra SARS-CoV-2 Assay, a real-time RT-PCR test intended for the qualitative detection of nucleic acid from SARS-CoV-2 in nasopharyngeal or oropharyngeal swab specimens from patients suspected of COVID-19 by their healthcare provider. Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, to perform high complexity tests. EUAs allow for the early availability of important diagnostic tools “when there are no adequate, approved and available alternatives.”¹
 
The Lyra product line offers PCR reagent kits for use by molecular diagnostic laboratories with existing molecular testing infrastructure such as the Applied Biosystems 7500 Fast DX instruments. These reagents include unique features that provide for simple transport and storage, improved workflow, shorter time to result, and other benefits that favorably affect diagnostic test outcome. The Lyra SARS-CoV-2 Assay provides these and certain additional advantages over other tests currently on the market for this novel coronavirus, including easier setup and faster time to result.
 
“Emergency Use Authorization for our Lyra SARS-CoV-2 Assay allows Quidel to join the global fight against the COVID-19 outbreak by providing healthcare workers in highly complex laboratories with a fast, accurate tool to diagnose patients infected with the novel coronavirus. The feature benefits of the test system and the Lyra product will contribute substantially to our country’s efforts to fight this pandemic,” said Douglas Bryant, President and CEO of Quidel. “We are proud to have quickly developed this assay in mere weeks, and to have manufactured kits, several of which are in transit to customers. Anticipating significant demand, we are allocating kits across a broad set of customers as we ramp production.”
 
The Lyra SARS-CoV-2 Assay is currently only available for sale in the United States and can be purchased either through Quidel’s salesforce or Cardinal Health.
 
Reference
¹ https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization