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

Ultimate Dx Laboratories

Business Name:
Ultimate Dx Laboratories
Business Genre:
Business Description:

Ultimate DX is an accredited Clinical Laboratory Improvement Amendments (CLIA) licensed laboratory. It is composed of a team of scientists providing biomedical testing in the field of infectious disease and pharmacology. [1]

City:
Los Angeles
State:
CA
Country:
USA
Complimentary Products Needed to Perform Test:
RNA Extraction reagents/machine (KingFisher Flex Purification System, ThermoFisher Scientific), RT-PCR platform (Applied Biosystems QuantStudio 12K platform)
Setting of Care:
only permitted use under EUA in Ultimate Dx Laboratories as High Complexity Molecular-Based Laboratory Developed Tests (CLIA lab) [2]
Current Status / Clinical Development Stage / Expected Milestones:
The reagent of the kit is manufactured by BGI Biotechnology, Wuhan Co.,Ltd. The tests can be done by collecting samples under instructions and sending them to UDX for testing. UDX also provides serology tests for immunity testing. [3] [5]
Funding & Ownership :
Clinical Laboratory Improvement Amendments (CLIA) licensed laboratory
Business Model:
UDX also provides testing services for other infectious diseases (gastrointestinal, respiratory, HPV, STI, and wound infection). [6]
IP:
N/A
History & Origins :
UDX focuses on providing customers with various diagnostics services in an accurate and timely manner. [6]
Date EUA Issued:
04/24/2020 [2]
Sources:
[1] https://ultimatedx.com/ [2] https://www.fda.gov/medical-devices/emergency-situations-medical-devices/emergency-use-authorizations [3] https://www.fda.gov/media/137372/download [4] https://ultimatedx.com/covid19/ [5] https://ultimatedx.com/covid19/ [6] https://ultimatedx.com/diagnostic-tests/ [7] https://www.cbrnetechindex.com/p/7533/Ultimate-Dx-Laboratory/UDX-SARS-CoV-2-Molecular-Assay
Organization:
Sean Tab (CEO) [7]
Time to Result:
UDX claimed 10,000 tests per day with a 24-hour turnaround time. [4]
Test Sample Type:
upper respiratory specimens (nasal swabs, nasopharyngeal swabs, oropharyngeal swabs) [3]
Technology Overview:
RT-PCR amplification for CoV-19 ORF1ab conserved region [3]
Testing Type:
nucleic acid detection
Test Category:
RT-PCR
Test Name:
UDX SARS-CoV-2 Molecular Assay
Clinical Application & Need:
acute/early infection

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