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

Quansys Biosciences

Business Name:
Quansys Biosciences
Business Genre:
Business Description:

The company specializes in development of singleplex and multiplex assays, primarily ELISA [1]

City:
Logan
State:
UT
Country:
USA
Data/Evidence of Effectiveness:
S1 detection Estimated Sensitivity (PPA) 97.1% & Estimated Specificity (NPA) 99.6%; S2 detection Estimated Sensitiviy (PPA) 97% & Estimated Specificity (NPA) 96%. Combined S1 and S2 detection Estimated Sensitivity(PPA) 97% &Estimated Specificity(NPA)100% [2]
Complimentary Products Needed to Perform Test:
“Nunc® MicroWell™ 96-Well Plates, Polypropylene, 249944; Eppendorf® LoBind Protein or Genomic Microcentrifuge Tubes, 022431102, Q-View™ Imaging System [2,3]”
Setting of Care:
Research and clinical laboratories and has not been reviewed by the FDA [3]
Current Status / Clinical Development Stage / Expected Milestones:
The test needs to obtain EUA and be reviewed by the FDA
Funding & Ownership :
Private [4]
Business Model:
The company has proprietary rights to the Q-plex Array Technology which allows users to measure up to 18 analytes at one time without compromising sensitivity [1] They make Q-Plex™ Arrays, Imagers and Software and offer sample testing services as well as customization of assays [1]
IP:
Proprietary Q-Plex Array Technology [1]
History & Origins :
The company was founded in 2004 by Dr. Rex S. Spendlove, who also is the founder of Hyclone Labs. Quansys Biosciences has been a leader in multiplex ELISA assay development [1]
Date EUA Issued:
N/A
Sources:
[1] http://quansysbio.com/company/ ; [2]http://quansysbio.com/multiplex/multiplex-assays/sars-cov-2-human-igg-4-plex/; [3]http://quansysbio.com/wp-content/uploads/2020/04/SARS-CoV-2-Human-IgG-4-Plex-Manual-2-9-04-20-lr.pdf ; [4]https://www.owler.com/company/quansysbio
Organization:
Adam Brown (CEO)
Time to Result:
2 hours [2]
Test Sample Type:
blood[2]
Technology Overview:
Qualitative enzyme-linked immunoabsorbent chemiluminescent assay (ELISA) that detects IgG antibodies to S1 or S2 spike proteins of SARS-CoV-2 in human plasma or serum [2]
Testing Type:
detects IgG antibodies only[2]
Test Category:
SEROLOGY
Test Name:
SARS-CoV-2 Human IgG (4-Plex)
Clinical Application & Need:
recent/prior infection/immunity [2]

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