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

Gnomegen

Business Name:
Gnomegen
Business Genre:
Business Description:

This company focuses on providing liquid biopsy tools for the detection of cancer [1]. Their technology uses Digital RT PCR to improve sensitivity and better multiplex in assays [1].

City:
San Diego
State:
CA
Country:
USA
Data/Evidence of Effectiveness:
No data presented but claims of 4X more sensitivity with a limit detection of 2.5 copies per reaction [1]. Claims digital PCR identifies 95% of positive sample replicates [1].
Complimentary Products Needed to Perform Test:
QuantStudio 3D Digital PCR systems [1]
Setting of Care:
Laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a [2]
Current Status / Clinical Development Stage / Expected Milestones:
EUA obtained and available for sale [2]
LOD:
57 [6]
Funding & Ownership :
Private (estimated revenue of < $1M) [3]
Business Model:
Makes and sells clinically ready reagents and products based on digital PCR and next generation sequencing [1].
IP:
Patent pending for Digital RT PCR Technology [1].
History & Origins :
Historically used real time digital PCR for companion diagnostics and monitoring by looking at HER2 and EGFR [1]. Leveraged the technology to make SARS-CoV-2 primers for virus detection [1]
Date EUA Issued:
4/6/2020 [2]
Sources:
[1]https://gnomegendx.com/ [2] https://gnomegendx.com/ [3]https://www.owler.com/company/gnomegen [4]https://www.proactiveinvestors.com/companies/news/912794/gnomegen-hopes-to-achieve-early-detection-of-cancer-relapse-with-its-liquid-biopsy-tools-912794.html [5] https://www.bio.org/events/bio-ceo-investor-conference/sessions/648993 [6] https://www.fda.gov/media/136738/download
Organization:
President and CSO: Yan Wang [4]
No. Tests Per Day:
96*8
Time to Result:
3 hours [1]
Test Sample Type:
Nasopharyngeal and oropharyngeal swab specimens collected by healthcare providers [2]
Technology Overview:
Pairs a microwell chip with RT-Digital PCR to reverse transcribe nucleic acids into cDNA [2]. The sample is then ran on an authorized RT PCR instrument to detect the human RP target and SARS-CoV-2 N gene [2]
Testing Type:
Digital RT-PCR [1]
Test Category:
RT-PCR
Test Name:
Gnomegen COVID-19 RT-Digital PCR Detection Kit [1]
Clinical Application & Need:
Qualitative test using digital PCR to detect SARS-CoV-2 nucleic acids in relevant samples [1]
Age of Company:
2011 [5]

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