ThermoFisher Scientific

Business Name: ThermoFisher Scientific
Business Genre:
Business Description:

Thermo Fisher Scientific is public, global, a large CAP ($135.437B) company that manufactures products for Life Sciences, Industrial Sciences, Clinical Diagnostics, and Lab solutions [6,7]

City: Boston
State: MA
Country: USA
Data/Evidence of Effectiveness: The TaqPath™ COVID-19 Combo Kit was validated using a multi-step process. They looked for reactivity in silico by mapping “185 complete SARS-CoV-2 genomes of human host in GenBank and GISAID databases as of March 5, 2020. Primer and probes sequences for SARS-CoV-2 ORF1ab, S gene, and N gene assays had 100% homology to all SARS-CoV-2 isolates analyzed, with one exception”. They check for interfering substances in mucin, blood, various nasal sprays, various lozenges, and more. [4]
Complimentary Products Needed to Perform Test: “• RNA extraction kit • PCR Master Mix. Recommended: TaqPath™ 1‑Step Multiplex Master Mix (No ROX™) (4X) • Real Time PCR instrument. • Consumables: 96 or 384 well plates, plastic film to cover plates, tubes, pipette tips • Basic laboratory supplies: centrifuge, vortex, pipettors [4]”
Setting of Care: “”” Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, to perform high complexity tests.”” [4]”
Current Status / Clinical Development Stage / Expected Milestones: “”” TaqPath™ COVID-19 Combo Kit is for use only under Emergency Use Authorization (EUA).”” [4]”
Funding & Ownership : Public IPO [2] with Market CAP of $135.437B [9]
Business Model: They manufacture products for Life Sciences, Industrial Sciences, Clinical Diagnostics, and Lab solutions [6]
History & Origins : They are an established company that specializes in life science and lab solutions, and already produce reagants and machines for RT-PCR. [1,6]
Date EUA Issued: 03/13/2020 [5]
Sources: [1] [2] [3] [4] [5] [6] [7] [8] [9]
Organization: Thermo Fisher Scientific is led by a Board of Directors, whose chairman is Marc Casper [8]
No. Tests Per Day: 24 hours/day / 4 hour runs = 6 runs/day. 94 samples/plate x 6 runs/day = 564 samples/day
Time to Result: Under 4 hours [3]
Test Sample Type: nasopharyngeal, oropharyngeal, nasal, mid-turbinate swabs, nasopharyngeal aspirate, and bronchoalveolar lavage (BAL) samples [4]
Technology Overview: detects presence of RNA originating from SARS-CoV-2 in samples using a multiplexed RT-PCR using 3 primers: ORF1ab, N gene, and S gene [4]
Testing Type: qualitative viral RNA test [4]
Test Category: RT-PCR
Test Name: TaqPath™ COVID-19 Combo Kit [3]
Clinical Application & Need: Detect SARS-CoV-2 RNA during acute infection [4]
Age of Company: 1956 [2]

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