Business Name: QIAGEN
Business Genre:
Business Description:

Global biotechnology company that manufactures sample isolation kits, instrumentation and software for bioinformatics, and medical diagnostics. [1]

State: Hilden
Country: Germany
Data/Evidence of Effectiveness: “The performance of SARS-CoV-2 target in the QIAstat-Dx Respiratory SARS-CoV-2 Panel was evaluated using retrospective nasopharyngeal swab clinical specimens in transport medium.” [9]
Complimentary Products Needed to Perform Test: nasopharyrangeal swab, viral transport medium, QIAstat-Dx Analyzer [6]
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 and moderate complexity tests.” [6]
Current Status / Clinical Development Stage / Expected Milestones: “not been FDA cleared or approved” and “only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostic tests for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner” [9]
Funding & Ownership : Public. M+A. Acquisition by Thermo Fisher Scientific for $11.5B was announced on March 3, 2020 but is still pending. [5]
Business Model: “Manufacturing sample isolation kits, instrumentation and software for bioinformatics, and medical diagnostics. [1] “
IP: There is a patent for their microfluidic cartridge [8]
History & Origins : QIAGEN specializes in nucleic isolation kits, instrumentation and software for bioinformatics, and medical diagnostics [1]. QIAGEN’s QIAstat Respiratory Panel was approved by the FDA in 2018 [10]. Their new SARS-CoV-2 basically just adds one more set of primers.
Date EUA Issued: 3/30/2020 [4]
Sources: [1], [2] [3] [4] [5] [6] [7] [8] [9] [10]
Organization: Thierry Bernard (CEO) [7]
No. Tests Per Day: 24 hours/day x 1 cartridge/hour= 24 tests/day
Time to Result: Results acquired 1 hour after loading sample [6]
Test Sample Type: nasopharyngeal swab dipped in universal transport media [6]
Technology Overview: Sample is loaded into the cartridge and placed into the QIAstat-Dx Analyzer. The device then automatically extracts RNA, performs qPCR, and analyzes results in about an hour. The software can detect and differentiate between SARS-CoV-2 and 20 other respiratory diseases [6]. Primers used are for E gene and orf1ab, similar to WHO test. [3]
Testing Type: qualitative viral RNA test [6]
Test Category: RT-PCR
Test Name: QIAstat Respiratory SARS-CoV-2 Panel [3]
Clinical Application & Need: Confirms whether a suspected COVID-19 patient has an acute SARS-CoV-2 infection or other respiratory infection [6]
Age of Company: 1986 [5]

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