Cellex Inc.

Business Name: Cellex Inc.
Business Genre:
Business Description:

Cellex Incorporated is a biotechnology company that develops technologies, instruments and assays for testing of human diseases and conditions, particularly at point-of-care (POC) settings [1, 2].

City: Research Triangle Park
State: NC
Country: USA
Data/Evidence of Effectiveness: ” qSARS-CoV-2 IgG/IgM Rapid Test had a Positive Percent Agreement and Negative Percent Agreement of 93.75% (95% CI: 88.06-97.26%) and 96.40% (95% CI: 92.26-97.78%), respectively [6]”
Complimentary Products Needed to Perform Test: All inclusive kit [6]
Setting of Care: laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. 263a, to perform moderate and high complexity test [4-6].
Current Status / Clinical Development Stage / Expected Milestones: FDA EUA approved and available for in vitro diagnostic use only [4-6].
Funding & Ownership : Private [1]
Business Model: They can produce purified antigen or monoclonal antibody conjugates to a marker. They have expertise in production of antigens produced either in mammalian or bacterial cells, monoclonal antibodies produced in hybridomas, and viral lysates/virus produced from large-scale cell cultures. A variety of tools are used to purify the antigens, monoclonal antibodies or viruses, including gel filtration chromatography, affinity chromatography, tangential flow filtration, and sucrose gradient ultracentrifugation [2].
History & Origins : Cellex Incorporated is a biotechnology company founded in 2002. They develop technologies, instruments and assays for testing of human diseases and conditions, particularly at point-of-care (POC) settings. Cellex was founded in the state of Maryland. Cellex moved its main operation to the Research Triangle Park (RTP), North Carolina, USA, where its main R&D staff is located. They also have a manufacturing facility [1, 2].
Date EUA Issued: 4/1/2020 [4]
Sources: 1. 2. 3. 4. 5. 6. 7.
Organization: X James Li (CEO) [7]
No. Tests Per Day: serology strip >2000/ day
Time to Result: 15-20 minutes [3]
Test Sample Type: whole blood, serum, plasma [3]
Technology Overview: Lateral flow chromatographic immunoassay which can detect and differentiate IgM and IgG antibodies against the SARS-CoV-2 virus [3]
Testing Type: qualitative detection and differentiation of IgM and IgG antibodies to SARS-CoV-2 [3]
Test Category: SEROLOGY
Test Name: qSARS-CoV-2 IgG/IgM Rapid Test [3]
Clinical Application & Need: “Aid in the diagnosis of patients with suspected SARS-CoV-2 infection in conjunction with clinical presentation and the results of other laboratory tests [6]”
Age of Company: 2002 [1,2]

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