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] [2] [3] [4] [5] [6] [7] [8]”
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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