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 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]
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]; [2]; [3]; [4]; [5]; [6]
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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