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

Quidel Corporation

Business Name: Quidel Corporation
Business Genre:
Business Description:

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

City: San Diego
State: CA
Country: USA
Data/Evidence of Effectiveness: Antigen viral protein tests are known to be less senstitive than molecular tests, which detect viral nucleic acids [5]. If COVID19 exposure is suspected but the test results come back negative, the patient should be retested and antigen test needs to be validated by a follow up molecular test [2,5] Must report every false positive and false negative test to FDA [2]
Complimentary Products Needed to Perform Test: Sofia 2 Instrument,Calibration Cassette (supplied with the Sofia 2 instrument), Timer or watch, Vortex, 1.0-mL Calibrated Micropipette with pipette tips, Nylon flocked nasopharyngeal swab, Polyester wound swab, Viral Transport Media (VTM) [4]
Setting of Care: authorized for use in CLIA certified labs (with Sofia 2 instruments) in patient care settings (i.e.CLIA certified clinical labs) [2]
Current Status / Clinical Development Stage / Expected Milestones: NOT FDA cleared/approved; FDA EUA [2,5]; for in vitro diagnosis only [4]; avaliable for purchase from Cardinal Health, Fisher Healthcare, Henry Schein, or McKesson [3]
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)
IP: N/A
History & Origins : The comThe 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 offer health providers to test and treat in one office visit.pany 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 offer health providers to test and treat in one office visit.
Sources: [1]https://www.quidel.com/about; [2] https://www.fda.gov/media/137886/download; [3] https://www.quidel.com/immunoassays/rapid-sars-tests/sofia-2-sars-antigen-fia; [4]https://www.quidel.com/sites/default/files/product/documents/EF1438900EN00_0.pdf; [5] https://www.quidel.com/sites/default/files/product/documents/FS2037400EN00.pdf; [6]https://www.quidel.com/sites/default/files/product/documents/FQ2037401EN00_0.pdf [7] https://ir.quidel.com/home/default.aspx
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: 1 minute extraction, 15- minute run time [2,3,6]
Test Sample Type: nasopharyngeal/nasal swab [2]
Technology Overview: antigen lateral flow immunofluorescence sandwich assay that detects SARS-CoV-2 nucleocapsid protein [3]
Testing Type: qualitative viral antigen protein detection [2]
Test Category: RT-PCR
Test Name: Sofia 2 SARS Antigen FIA [2]
Clinical Application & Need: acute infection [2]

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