Quidel’s Lyra® Direct SARS-CoV-2 Assay Submitted for Emergency Use Authorization for Molecular Detection of COVID-19, Without Extraction Step
Quidel Corporation (QDEL)
Last quidel 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 has applied for an Emergency Use Authorization (EUA) for the Lyra® Direct SARS-CoV-2 Assay from the Food and Drug Administration (FDA) to allow direct sample processing. The assay will be run on the same six different instruments as the Lyra® SARS-CoV-2 Assay.Lyra® Direct Removes RNA Extraction Processing Step, Removes Supply Bottleneck Under the new EUA, the Lyra® Direct SARS-CoV-2 Assay no longer requires an upfront sample extraction. The Lyra® Direct SARS-CoV-2 Assay uses a reformulated buffer that replaces the extraction step with a simple 10-minute heat step, saving approximately 50 minutes in processing time. The assay retains its versatility in that it is still capable of running on any of six thermocyclers (Applied Biosystems 7500 Standard®, Applied Biosystems
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QDEL
Earnings
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Sec Filings
- 12/1/25 - Form 4
- 11/25/25 - Form 4
- 11/25/25 - Form 144
- QDEL's page on the SEC website