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March 21, 2020 at 3:57 pm

Quidel Joins Fight Against COVID-19 Outbreak with Fast, Accurate Diagnostic Tool

quidel logo

Quidel Corp., which employs many Ohio University alumni in Athens, joins the fight against COVID-19 outbreak with fast, accurate diagnostic tool, according to a news release.

The company announced on March 17 that it received Emergency Use Authorization from the U.S. Food and Drug Administration for a molecular COVID-19 diagnostic assay.

The Athens Messenger reported:

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.”

From the news release:

Quidel, a provider of rapid diagnostic testing solutions, cellular-based virology assays and molecular diagnostic systems, announced today that Quidel 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.

About Quidel

Quidel Corp. is a leading manufacturer of diagnostic healthcare solutions serving to enhance the health and well-being of people around the globe with well-known and respected products that provide healthcare professionals with accurate and cost-effective diagnostic information at the point of care. Its core competencies and capabilities focus on immunoassay and molecular testing in the areas of infectious disease, women’s health, and virology.

Quidel is headquartered in San Diego, with research and manufacturing operations in Ohio, Massachusetts, and Germany. Quidel and Ohio University are working together to support alumni in pursuit of rewarding career opportunities.

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