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]
History & Origins : Company with extensive experience in numeral area in biotechnology, including diagnostics. [1]
Date EUA Issued: 03/27/2020 [2]
Sources: “[1] [2] [3] (IFU) [4] [5] [6] [7] [8]”
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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