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Avellino Lab USA, Inc.

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Business Name:
Avellino Lab USA, Inc.
Business Genre:
Business Description:

The company is focused on precision medicine, and creating oppurtunities for earlier disease protection, staring with opthalmology [1]

Website:
https://www.avellino.com/en/
City:
Menlo Park
State:
CA
Country:
USA
Data/Evidence of Effectiveness:
100 % positive and negative agreement on the patient samples [3]
Complimentary Products Needed to Perform Test:
QIAamp DSP Viral RNA Mini Kit, RT-qPCR Master Mix, and Applied Biosystems 7500 Fast Real-Time PCR System [3]
Setting of Care:
“Testing is limited to Avellino Lab USA, Inc., that is certified under Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a to perform high complexity tests. [2]”
Current Status / Clinical Development Stage / Expected Milestones:
EUA approval and available for sale [2]
LOD:
55000 [3]
Funding & Ownership :
Private (Accelerator/Incubator Backed) [5]
Business Model:
Company sells proudcts related to genetic tests for diagnostic [4]
IP:
N/A
History & Origins :
Found in 2008 to provide provide genetic testing and diagnostic services [1]
Date EUA Issued:
March 25, 2020 [2]
Sources:
“[1] https://www.avellino.com/en/about/ [2] https://www.fda.gov/media/136450/download [3] https://www.fda.gov/media/136453/download (EUA summary) [4] https://www.avellino.com/en/products/diagnostics/ [5] https://pitchbook.com/profiles/company/170839-00#funding [6] https://www.avellino.com/en/about/leadership/ [7] https://www.avellino.com/en/contact/”
Organization:
Gene Lee (Founder), Tara Moore (Director of R&D), Thomas Kim (CSO), Scott Korney (COO) [6]
No. Tests Per Day:
assume prep time + run time 3 hrs for every 96 samples, ~800 / day
Time to Result:
Not stated, but should be similar to other RT-PCR based method
Test Sample Type:
nasopharyngeal and oropharyngeal swab [2]
Technology Overview:
“A real-time reverse transcription polymerase chain reaction(rRT -PCR) test. Use two sets of primers to detect two regions in SARS-CoV-2 nucleocapsid (N) gene and one set of primer to detect human RNase P (RP). [3]”
Testing Type:
Viral rRT-PCR test [2]
Test Category:
RT-PCR
Test Name:
AvellinoCoV2 test
Clinical Application & Need:
Qualitative detection of nucleic acid from SARS-CoV-2 [2]
Age of Company:
2008

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