Quidel Corporation, an Athens-based company that creates cellular-based testing assays, announced Thursday that it has received Emergency Use Authorization from the Food and Drug Administration to market a new, faster version of the COVID-19 test.
The test is called the Lyra SARS-CoV-2 Assay and is a real-time RT-PCR test intended for the “qualitative detection of nucleic acid from swab specimens from patients suspected of COVID-19.” The test works by looking at nucleic acid components in samples collected from patients, with any presence of the SARS-CoV-2 RNA indicating a positive test result.
Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 to perform high complexity tests, such as OhioHealth’s labs and Quidel’s. EUAs allow for the early availability of important diagnostic tools “when there are no adequate, approved and available alternatives.”
The Lyra product line offers reagents from existing molecular testing infrastructure. The reagents include features that provide for simple transport and storage, improved workflow, shorter time to result and other favorable benefits.
“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,” said Douglas Bryant, President and CEO of Quidel.
“The feature benefits of the test system and the Lyra product will contribute substantially to our country’s efforts to fight this pandemic,” he continued. “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.”
Currently, no FDA-approved diagnostics, vaccines or treatments for COVID-19 are available.
Quidel is one of numerous companies in recent weeks that have received such emergency approval, allowing the companies to market diagnostic assays to detect the novel coronavirus. Quidel’s SARS-CoV-2 test is currently only available for sale in the United States, the company said.