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]
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] [2] [3] [4] [5] [6] [7] [8]
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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