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

ScienCell Research Laboratories

Business Name:
ScienCell Research Laboratories
Business Genre:
Business Description:

Biotechnology company that provides “a variety of high quality normal human and animal cells, cell culture media and reagents, gene analysis tools, cell-derived molecular biology products, cell-based assay kits, and stem cell products for the research community” [2]

State:
CA
Country:
USA
Data/Evidence of Effectiveness:
1-2x LoD PPA=100% (83.9%, 100%); 3-5x LoD PPA=100% (72.3%, 100%); Negative 100% (88.7%, 100%) [4]
Complimentary Products Needed to Perform Test:
Viral RNA isolation or extraction kit, LightCycler® 96 Real-Time PCR System with LightCycler® Software 1.01.01.0050 and comsumables [4]
Setting of Care:
CLIA certified laboratories [3]
Current Status / Clinical Development Stage / Expected Milestones:
FDA-EUA approved [3]
Funding & Ownership :
Private[1]
Business Model:
ScienCell specializes on primary cells, cell culture media (STEMium™), stem cells, cell based assays and growth factors [5]
IP:
N/A
History & Origins :
The company was founded in 1999 and it’s based in San Diego, CA [5]
Date EUA Issued:
4/3/2020 [3]
Sources:
[1] https://www.crunchbase.com/organization/sciencell-research-laboratories; [2] https://www.sciencellonline.com/about.html; [3]https://www.fda.gov/media/136688/download; [4] https://www.fda.gov/media/136691/download; [5] https://www.sciencellonline.com/about.html; [6] https://sciencellonline.com/blog/sciencell-a-unique-provider-of-primary-schwann-cells-worldwide/
Organization:
James Shen (CEO)[6]
Time to Result:
Not specified
Test Sample Type:
“nasal, nasopharyngeal/oropharyngeal swab specimens, and bronchoalveolar lavage [3]”
Technology Overview:
RT-PCR test “based on nucleic acid amplification technology and the standard hydrolysis probe system known as TaqMan® Technology” [4]
Testing Type:
qualitative in vitro detection of nucleic acid from SARS-CoV-2 [3]
Test Category:
RT-PCR
Test Name:
ScienCell SARS-CoV-2 Coronavirus Real-time RT-PCR (RTqPCR) Detection Kit
Clinical Application & Need:
acute phase [3]

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