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

Abbott Diagnostics Inc.

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

A global healthcare company with marketing more than 160 countries. They focus on the area in diabetes, diagnostics, nutritients, neuromodulation. [1]

City:
Abbott Park
State:
IL
Country:
USA
Data/Evidence of Effectiveness:
Urgent care studies showed >94.7 % positive agreement (sensitivity) and >98.6 % negative agreement (specificity) with lab-based PCR methods to detect CoV-2 virus. [4]
Complimentary Products Needed to Perform Test:
An instrument-based isothermal test. Need the ID NOW Instrument, sample receiver, elution/lysis buffer, and a test base [3]
Setting of Care:
Authorized laboratories – laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, to perform high and moderate complexity tests. Other Authorized Testing Locations – patient care settings using the ID NOW Instrument. [2]
Current Status / Clinical Development Stage / Expected Milestones:
Authorized under EAU. Waive current good manufacturing practice requirements under EAU. For in vitro diagnostics only. [2]
LOD:
125 [4]
Funding & Ownership :
Public (Market Cap $158.5B) [6-7]
Business Model:
Sell various medical products related to diabetes, cardiovascular, diagnostics, neuromodulation, nutrition, pharmatheuticals [1]
IP:
N/A
History & Origins :
Company with extensive experience in numeral area in biotechnology, including diagnostics. [1]
Date EUA Issued:
03/27/2020 [2]
Sources:
“[1] https://www.abbott.com/ [2] https://www.fda.gov/media/136522/download [3] https://www.fda.gov/media/136522/download (IFU) [4] https://abbott.mediaroom.com/2020-05-21-Abbott-Releases-Interim-Clinical-Study-Data-on-ID-NOW-COVID-19-Rapid-Test-Showing-Strong-Agreement-to-Lab-Based-Molecular-PCR-Tests [5] [6] https://www.crunchbase.com/organization/abbott [7] https://finance.yahoo.com/quote/ABT/ [8] https://www.abbott.com/corpnewsroom/utilities/executive-team.html”
Organization:
Robert B. Ford (CEO), John Ginascol, Andrea Wainer, Jaime Contreras, Christopher Scoggins (VP for Diagnostics) [8]
No. Tests Per Day:
single test can be done in 13 mins, roughly 6 per hours, that would be 144 per day
Time to Result:
13 minutes or less [3]
Test Sample Type:
Throat swab, nasal swab, nasopharyngeal swab [3]
Technology Overview:
Ultilize isothermal nucleic acid amplification technology to detect the CoV-2 virus RNA in the sample [3]
Testing Type:
Qualitative viral RNA test [3]
Test Category:
SEROLOGY
Test Name:
ID NOW COVID-19
Clinical Application & Need:
acute infection [2]
Age of Company:
1888

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