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

BioMérieux SA

Business Name:
BioMérieux SA
Business Genre:
Business Description:

A company focused on in vitro diagnostics for more than 55 years. Present in 44 countries and serves more than 160 countries. [2]

Country:
France
Data/Evidence of Effectiveness:
For target genesN & RdRp gene), there was 100% positive agreement and 100% negative agreement [4]
Complimentary Products Needed to Perform Test:
Depends on the instrument of choice. Extraction systems validated with the kit, and Amplification platforms validated with the kit. [4]
Setting of Care:
Laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, to perform high complexity tests. [3]
Current Status / Clinical Development Stage / Expected Milestones:
EUA approval and available for sale [2]
LOD:
380 [4]
Funding & Ownership :
Public [6], Cap: 15.201 B [7]
Business Model:
Sell proudcts that is related to clinical diagnostics. Provide several management to infectious dieseases as well as selling the kit for diagnostics. [5]
IP:
“Some of the reagents in the kits is the subject of one or more issued US patents. [4]”
History & Origins :
The company has an entrepreneurial spirit and many products, services and solutions for in vitro diagnostics are developed in-house. Recently merge with several different companies. [8]
Date EUA Issued:
05/06/2020 [2]
Sources:
“[1] https://www.biomerieux.com/en [2] https://www.biomerieux.com/en/our-company [3] https://www.fda.gov/media/137743/download [4] fda.gov/media/137742/download [5] https://www.biomerieux-diagnostics.com/ [6] https://www.crunchbase.com/organization/biomerieux [7] https://finance.yahoo.com/quote/BIM.PA?p=BIM.PA [8] https://www.biomerieux-diagnostics.com/our-clinical-history”
Organization:
“Stephane Bancel (CEO), Carine Malcus-Vocanson (Director of clinial affairs) [6]”
No. Tests Per Day:
assume prep time + run time 3 hrs for every 96 samples, ~800 / day
Time to Result:
Depends on the instrument of use. Similar to tradition RT-PCR methods [4]
Test Sample Type:
Nasopharyngeal swabs, oropharyngeal (throat) swabs, anterior nasal swabs, mid-turbinate nasal swabs, nasal aspirates, nasal washes and bronchoalveolar lavage (BAL) fluid [3]
Technology Overview:
Can be paired with several extraction and amplification instruments. Target the N gene and RdRp gene of the SARS-CoV-2. [4]
Testing Type:
Real-time reverse transcriptase (RT)-PCR test [4]
Test Category:
RT-PCR
Test Name:
SARS-COV-2 R-GENE
Clinical Application & Need:
Qualitative detection of nucleic acid from SARS-CoV-2 [3]
Age of Company:
1963

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