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

Abbott Molecular

Business Name: Abbott Molecular
Business Genre:
Business Description:

Abbott is a leader in molecular diagnostics with over 1000 employeess focused on exploring areas including infectious disease, oncology and instrumentation [1].

City: Abbott Park
State: IL
Country: USA
Data/Evidence of Effectiveness: Inclusivity was established by comparing the primers used in this kit to SARS-CoV-2 sequences available in Genbank as of March 5 2020 [4].
Complimentary Products Needed to Perform Test: Abbott RealTime m2000 system [2]
Setting of Care: Laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a [2].
Current Status / Clinical Development Stage / Expected Milestones: EUA authorized. Waived current good manufacturing practice requirements [5]. Designed for only in vitro diagnostic use [2].
LOD: 100 [10]
Funding & Ownership : Public, Market Cap – $161.797B [7].
Business Model: Abbott offers solutions across various facets of the life sciences including instrumentation, infectious diseases, informatics, oncology, and genomics [6]
IP: N/A for the kit but presumably the m2000 has some proprietary protection.
History & Origins : Previous experience in genomics, infectious diseases and oncology allowing for an easy pivot into SARS-CoV-2 diagnostics [8].
Date EUA Issued: 03/18/2020 [3]
Sources: [1] https://www.molecular.abbott/us/en/home [2] https://www.molecular.abbott/us/en/products/infectious-disease/RealTime-SARS-CoV-2-Assay [3] https://www.fda.gov/medical-devices/emergency-situations-medical-devices/emergency-use-authorizations [4] https://www.molecular.abbott/sal/9N77-095_SARS-CoV-2_US_EUA_Amp_PI.pdf [5] https://www.fda.gov/media/136255/download [6] https://www.molecular.abbott/us/en/offerings/products [7] https://finance.yahoo.com/quote/ABT/ [8] https://www.molecular.abbott/us/en/offerings/products/featured [9] https://finance.yahoo.com/quote/ABT/profile?p=ABT [9] https://en.wikipedia.org/wiki/Abbott_Laboratories [10] https://www.fda.gov/media/136258/download
Organization: Robert B. Ford (CEO, Pres, COO & Director), Robert E. Funck Jr (Executive VP of Finance and CFO), Lisa D. Earnhardt (Executive VP of Medical Devices), Miles D. White (Executive Chairman), Scott Michael Leinenweber (VP of Investor Relations) [9]
No. Tests Per Day: 470 [2]
Time to Result: Up to 470 pateint samples tested in 24 hours [2].
Test Sample Type: Self-collected nasal swabs, nasopharyngeal and oropharyngeal swabs collected by a healthcare worker [2].
Technology Overview: A fully automated solution, which uses RT-qPCR to detect RdRP and N-genes from nasal samples [2]
Testing Type: Qualitative RT-qPCR test for nucleic acids [2]
Test Category: RT-PCR
Test Name: Abbott RealTime SARS-CoV-2 assay
Clinical Application & Need: Qualitative detection of nucleic acids from SARS-CoV-2 [2].
Age of Company: 1888 [9]

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