Quidel has secured emergency use authorisation (EUA) from the US Food and Drug Administration (FDA) for its molecular COVID-19 diagnostic assay.
The real-time RT-PCR test, Lyra SARS-CoV-2 assay, will help healthcare providers in the qualitative detection of nucleic acid from SARS-CoV-2 in nasopharyngeal or oropharyngeal swab specimens from patients suspected of COVID-19.
Quidel’s Lyra product line includes PCR reagent kits, which can be used by molecular diagnostic laboratories with existing molecular testing infrastructure such as the Applied Biosystems 7500 Fast DX instruments.
The Lyra SARS-CoV-2 assay is currently marketed only in the US
At present, the Lyra SARS-CoV-2 assay is only provided in the US and can be purchased either via Quidel’s salesforce or Cardinal Health.
The test will be provided to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) to conduct high complexity tests.
Quidel president and CEO Douglas Bryant said: “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.”
Quidel supplies rapid diagnostic testing solutions, cellular-based virology assays and molecular diagnostic systems to its customers.
The company markets its products under brand names such as Sofia, QuickVue, D3 Direct Detection, Thyretain, Triage and InflammaD, as well as Solana, AmpliVue and Lyra.
In October 2017, Quidel secured FDA approval for its Solana respiratory syncytial virus (RSV) + human metapneumovirus (hMPV) assay.
Solana RSV + hMPV assay will be used to detect nucleic acids isolated from nasal and nasopharyngeal swabs from patients with signs and symptoms of respiratory infection.
