NONPROFIT, NONPARTISAN PLATFORM OF ACCURATE SCIENCE-BASED SOLUTIONS TO COVID-19

Quidel Corporation

Business Name: Quidel Corporation
Business Genre:
Business Description:

Diagnostic company specializing in automated manufacturing and development of immunoassays, molecular assays and monoclonal antibodies [1]

City: San Diego
State: CA
Country: USA
Data/Evidence of Effectiveness: The limit of detection (LoD) is 8.00E-01 genomic RNA copies/µL. The EUA for this test was expanded so that it can be run on multiple thermocyclers. It also recieves a CE mark, which means that it is not constricted thermocycler platform [4-5]
Complimentary Products Needed to Perform Test: bioMerieux NucliSENS® easyMAG® or EMAG systems for extraction; ABI 7500 Fast Dx for amplification and detection; Any of the following thermocyclers: Applied Biosystems® 7500 Fast Dx, Applied Biosystems 7500 Standard, QuantStudioTM Real-Time PCR Instrument, Roche LightCycler® 480, BioRad CFX96 Touch, or Qiagen Rotor-Gene Q; 96 well PCR plate; VTM and swabs; Quiagen RNA extraction kit [2,4]
Setting of Care: authorized laboratories in patient settings [2]
Current Status / Clinical Development Stage / Expected Milestones: Not FDA cleared/approved; Expanded EUA and received CE mark [2,5]
Funding & Ownership : Owned by investors [1]
Business Model: sale of lateral flow devices (infectious diseases & reproductive health) (QuickVue), immunoassays (Sofia, Triage), micro-titer production for bone markets (MicroVue), direct fluorescent antibodies, molecular diagnostics (AmpliVue), and DHI cell culture (ELVIS, Copan) [1]
IP: N/A
History & Origins : Company has a strong hold of the Point-of-Care diagnostic testing market (11% CAGR before acquiring Triage) It’s R&D department has received over 30 FDA clearances. Sofia and Triage offers health providers to test and treat in one office visit.
Sources: [1] https://www.quidel.com/about; [2] https://www.fda.gov/media/136224/download; [3]https://www.quidel.com/molecular-diagnostics/lyra-sars-cov-2-assay; [4] https://www.quidel.com/sites/default/files/product/documents/PIM120001EN00.pdf; [5] https://www.quidel.com/sites/default/files/product/documents/FQM120002EN00.pdf
Organization: Douglas C. Bryant (President/CEO); Randall F. Steward (CFO); Werner Kroll (SVP R&D); SVPs Karen Gibson, Michael D. Abney Jr, Ratan Borkar, Robert J. Bujarski, Edward Russell [7[
Time to Result: 75 minutes [3]
Test Sample Type: nasopharyngeal/ nasal swab/ oropharyngeal [2-3]
Technology Overview: RT-PCR qualitative assay that detects SARS-CoV-2 non-structural protein (ppa1b) RNA[2-4]
Testing Type: in vitro qualitative detection of viral nucleic acids [2-3]
Test Category: RT-PCR
Test Name: Lyra SARS-CoV-2 Assay [2]
Clinical Application & Need: acute infection [2]

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