Quidel’s Lyra® SARS-CoV-2 Assay Receives Authorization for Expanded Use for Molecular Detection of COVID-19; Also Receives CE Mark, Health Canada Authorization
QuidelOrtho Corporation (QDEL)
Last quidelortho corporation earnings: 2/12 04:10 pm
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Source: Business Wire
SAN DIEGO--(BUSINESS WIRE)--Quidel Corporation (NASDAQ: QDEL) (“Quidel”), a provider of rapid diagnostic testing solutions, cellular-based virology assays and molecular diagnostic systems, announced today that Quidel’s Lyra® SARS-CoV-2 Assay has received expanded Emergency Use Authorization (EUA) claims from the Food and Drug Administration (FDA) to allow testing with three additional thermocyclers: Applied Biosystems 7500 Standard, Roche LightCycler 480, and Qiagen Rotor-Gene Q.1 Acceptable Specimens Expanded to Include Nasal and Nasal Turbinate Swabs 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 Lab
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QDEL
Earnings
- 11/7/24 - Beat
QDEL
Sec Filings
- 12/13/24 - Form 4
- 12/10/24 - Form 3
- 12/10/24 - Form 3
- QDEL's page on the SEC website