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

GenoSensor Corporation

Business Name:
GenoSensor Corporation
Business Genre:
Business Description:

They are primary focused on genomics technologies that are used for research, drug discovery, predisposition gene screening, therapeutic assessment and other life science applications. [2] While GenoSensor Coporation helps labs worldwide, they have achieved nationwide leadership in bioassay services and development by integrating high-throughput laboratory and microarray fabrication facilities. [2]

City:
Tempe
State:
AZ
Country:
USA
Data/Evidence of Effectiveness:
GenoSensor claims “targeted specificity to 100% of currently available complete genomes for SARS-CoV-2” [3]. However, I could not find any publications.
Complimentary Products Needed to Perform Test:
Runs on the Applied Biosystems 7500 Fast Dx Real-Time PCR Instrument [3]
Setting of Care:
“Laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. § 263a, to perform high complexity test” [4]
Current Status / Clinical Development Stage / Expected Milestones:
Available to purchase now. Received authorization by the FDA under an EUA in authorized labs [3]. Only authorized for the duration of emergency circumstances under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1). [3]
LOD:
1000 [4]
Funding & Ownership :
Private company [6]. No other information on ownership. Annual revenue is $12.7M [6].
Business Model:
Products can be purchased directly from the company or from distributors [5]
IP:
N/A
History & Origins :
The company focuses on genomic technologies and has previous experience providing PCR/qRT-PCR kits and DNA extraction kits [7]
Date EUA Issued:
04/16/2020 [4]
Sources:
[1] https://www.linkedin.com/company/genosensor-corporation/ [2] http://www.genosensorcorp.com/profile.html [3] http://www.genosensorcorp.com/COVID19Kit.html [4] https://www.fda.gov/media/137090/download [5] http://www.genosensorcorp.com/order.html [6] https://www.owler.com/company/genosensorcorp [7] http://www.genosensorcorp.com/index.html [8] https://www.linkedin.com/company/genosensor-corporation/about/
Organization:
James Xia (President) [4]
No. Tests Per Day:
Comes in a 96 or 384 well format, which translate to 22 or 94 clincial samples. For 96-well (22 clinical samples * 16 = 352) and for the 384 well format (96 clinical samples * 16 = 1536)
Time to Result:
Less than 90 minutes [3]
Test Sample Type:
nasopharyngeal/oropharyngeal swabs, nasal swabs and mid-turbinate swabs [4]
Technology Overview:
Detects 3 target genes unique to SARS-CoV-2 virus, which are less prone to mutation. [3]
Testing Type:
Qualitative real time PCR test [3]
Test Category:
RT-PCR
Test Name:
GS COVID-19 Real Time PCR Kit
Clinical Application & Need:
Confirms current suspected COVID-19 infection in patients [3]
Age of Company:
GenoSenor was founded in 2003 [8]

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