Policy & Regulation
Quidel's Lyra SARS-CoV-2 Assay Receives Authorisation from US FDA for Expanded Use for Molecular Detection of COVID-19
26 March 2020 - - US-based rapid diagnostic testing solutions provider Quidel Corp.'s (NASDAQ: QDEL) Lyra SARS-CoV-2 Assay has received expanded Emergency Use Authorization claims from the Food and Drug Administration to allow testing with three additional thermocyclers: Applied Biosystems 7500 Standard, Roche LightCycler 480, and Qiagen Rotor-Gene Q, the company said.

Under the initial EUA, the Lyra SARS-CoV-2 Assay real-time RT-PCR test was 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.

The list of acceptable specimens has been expanded by the CDC to include nasal and nasal turbinate swabs.

Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988, 42 USC. §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."

The Lyra 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 many other tests currently on the market for this novel coronavirus, including easier set-up and faster time to result.

Separately, the Lyra SARS-CoV-2 Assay received CE-Mark on March 25, 2020.

The CE Mark allows Quidel to market and sell the Lyra SARS-CoV-2 Assay in Europe, as well as other countries that accept the CE Mark.

Also, on March 25, 2020, Quidel received authorization from Health Canada to market and sell the assay in Canada.

The assay is currently available for sale in the United States under EUA and can be purchased by laboratory professionals through Quidel directly, or through their Cardinal Health representative.

Quidel Corp. serves to enhance the health and well-being of people around the globe through the development of diagnostic solutions that can lead to improved patient outcomes and provide economic benefits to the healthcare system.

Marketed under the Sofia, QuickVue, D3 Direct Detection, Thyretain, Triage and InflammaDry leading brand names, as well as under the new Solana, AmpliVue and Lyra molecular diagnostic brands, Quidel's products aid in the detection and diagnosis of many critical diseases and conditions, including, among others, influenza, respiratory syncytial virus, Strep A, herpes, pregnancy, thyroid disease and fecal occult blood.

Quidel's recently acquired Triage system of tests comprises a comprehensive test menu that provides rapid, cost-effective treatment decisions at the point-of-care, offering a diverse immunoassay menu in a variety of tests to provide diagnostic answers for quantitative BNP, CK-MB, d-dimer, myoglobin, troponin I and qualitative TOX Drug Screen.

Quidel's research and development engine is also developing a continuum of diagnostic solutions from advanced immunoassay to molecular diagnostic tests to further improve the quality of healthcare in physicians' offices and hospital and reference laboratories.
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