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

LabGenomics Co., Ltd

Business Name:
LabGenomics Co., Ltd
Business Genre:
Business Description:

Republic of Korea-based healthcare device company, serves all of South Korea and provides medical diagnostic tests specifically related to genetic analysis [1]

City:
Seongnam-si
State:
Gyeonggi-do
Country:
Republic of Korea
Data/Evidence of Effectiveness:
Limit of detection is 20 genomic RNA copies/uL, was tested by spiking SARS-CoV-2 genomic RNA into negative clinical nasopharyngeal swabs or sputum. Tested a large selection of viral and bacterial strains for cross reactivity and did a Blastn search and found no other strains with >70% homology to primers for specificity. With positive (n=50) and negative (n=100) samples, claimed 100% accurate detection for both groups. [3]
Complimentary Products Needed to Perform Test:
nasal swab, included kit reagents [3], laboratory equipment listed in manual including thermal cycler (Applied Biosystems™ 7500 Real-time PCR Instrumentsystem or BioRad CFX96™ Real-time PCR detection system), RNA extraction kits (Qiagen) [4], microcentrifuge, refrigerator, -20C and -80C freezers
Setting of Care:
“laboratories certified under Clinical Laboratory Improvement Amendments of 1988 (CLIA) 42 U.S.C. §263a, to perform high complexity tests”. Positive results in the US and territories must be reported to public health authorities” [3]
Current Status / Clinical Development Stage / Expected Milestones:
Authorized under Emergency Use Authorization (EUA) granted 4/29/20 [3] [4]. For in vitro diagnotstic use only [3]. Currently available for purchase [3]
Funding & Ownership :
privately owned by investors [6]
Business Model:
molecular diagnostics company that provides genetic analysis and next generation sequencing (NGS) technologies like DNA chip, PCR kits, POCT, and other genetic analysis medical devices. Major products are the NIPT (non invasive prenatal test), Cancer panel, Predisposition panel, and prenatal gene tests [1]
IP:
manual is copyrighted, but no patents [3]
History & Origins :
Entire product selection focuses on molecular diagnotstics and specifically already produced PCR kits for detection of other infectious diseases (Dengue, Malaria, TB) [1]
Date EUA Issued:
4/29/2020 [5]
Sources:
[1] http://www.labgenomics.co.kr/eng/ [2] https://drive.google.com/file/d/1QIq_WymBPrhncYOwKbxA3kY8J9TgmNv2/view (brochure) [3] https://drive.google.com/file/d/1gvwW3BspzrhR4VEK_7jnM83wjfbbxoAv/view (manual) [4] https://www.qiagen.com/us/products/diagnostics-and-clinical-research/sample-processing/qiaamp-viral-rna-mini-kit/#orderinginformation [5] https://www.360dx.com/coronavirus-test-tracker-launched-covid-19-tests [6] https://www.crunchbase.com/organization/labgenomics#section-overview [7] https://www.bloomberg.com/profile/company/084650:KS
Organization:
Chin Sung-Hyun (Rep Director, CEO); Heo Hye-Jin, Jang Hong-Seok, Kim Jae-Young, No Seung-Jae, Shin In-Kyung, Won Yong-Sik (Executive Directors); Chin Sung-Hyun, An Sung-Yong, Won Yong-Sik (Board Members) [7]
Time to Result:
3.5 hr for 1 plate run, can be scaled up as are on 96 well plates [2]
Test Sample Type:
sputum, tracheal aspirate, nasopharyngeal and oropharyngeal fluids, nasal swab [2] [3]
Technology Overview:
detects nucleic acid from SARS-CoV-2 in nasal swabs, aspirate, and sputum using RT-PCR targeting the RdRp gene and the E gene [3]
Testing Type:
RT-PCR virus test [2-3]
Test Category:
RT-PCR
Test Name:
LabGun COVID-19 RT-PCR Kit [2]
Clinical Application & Need:
detect current COVID-19 infection from nasal swab or sputum sample [2][3]

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