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

Abbott Laboratories Inc.

Business Name:
Abbott Laboratories Inc.
Business Genre:
Business Description:

global healthcare company in over 160 countries, product portfolio focuses on diagnostics, medical devices, generic medicines, and nutritionals [1]

City:
Abbott Park
State:
IL
Country:
USA
Data/Evidence of Effectiveness:
Many claims in health care provider fact sheet that false positive and false negatives may occur [4]. Control and calibration samples are available to increase robustness of test [3]. U of Washington published in J Clin Microbiol that test had “99.9% specificity and 100% sensitivity for detecting the IgG antibody in patients 17 days or more after symptom began.” [5]
Complimentary Products Needed to Perform Test:
serum separator tube (serum) or lithium heparin in separator tube (plasma) and ARCHITECT i1000SR or i2000SR systems (Abbott instruments) [3], SARS-CoV-2 IgG calibrator and control kit (sold separately), instructions available at https://www.fda.gov/medical-devices/emergency-situations-medical-devices/emergency-use-authorizations
Setting of Care:
authorizied laboratories (required to report results to healthcare providers and public health authorities) [3]
Current Status / Clinical Development Stage / Expected Milestones:
NOT FDA cleared/approved; FDA approved to meet EUA criteria [3]. Under EUA, cGMP requirements have been waived [3]; for in vitro diagnostic use ONLY [3]; currently available for purchase [2]
Funding & Ownership :
Public (Market Cap $158.5B) [7]
Business Model:
sale of medical products focused on cardiovascular, diabetes care, neuromodulation, nutrition, and diagnostics and consumer products including some popular brands such as ENSURE protein drinks, ZONEPERFECT bars, PEDIALYTE and PEDIASURE [1]
IP:
N/A
History & Origins :
Company has extensive experience in creating diagnostic tests. Previous focus includes immunosassays, hematology assays, photometric and potentiometric assays. [1]
Date EUA Issued:
4/26/2020 [3]
Sources:
[1] https://www.abbott.com/; [2] https://www.corelaboratory.abbott/us/en/offerings/segments/infectious-disease/sars-cov-2; [3] https://www.fda.gov/media/137384/download; [4] https://www.corelaboratory.abbott/sal/faq/SARS-CoV-2IgGEUARecipientFactSheet.pdf; [5] https://jcm.asm.org/content/early/2020/05/07/JCM.00941-20; [6] https://www.abbott.com/corpnewsroom/utilities/executive-team.html [7] https://finance.yahoo.com/quote/ABT/
Organization:
Robert B. Ford (President/CEO); Miles D. White (Executive Chairman); Executive VPs for diagnostics (John Ginascol, Andrea Wainer, Jaime Contreras, Christopher Scoggins) [6]
Time to Result:
29 minutes for 1 result; 4000 results in 24hr [2]
Test Sample Type:
serum or plasma [3]
Technology Overview:
detects adaptive immune response using a two-step immunoassay using chemiluminescent microparticle immunoassay (CMIA) technology [2-3]
Testing Type:
qualitative IgG antibody test [3]
Test Category:
SEROLOGY
Test Name:
SARS-CoV-2- IgG assay [2]
Clinical Application & Need:
detect current, recent, or prior infection [3]

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