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

Seegene Inc

Business Name: Seegene Inc
Business Genre:
Business Description:

Founded 2000, and since then produced medical diagnostics testing for clinical and research settings, automated instrumentation for diagnostic testing and RT-PCR [3]. Has FDA clearance on other tests, and now is an international company [4]

State: Seoul
Country: Republic of Korea
Data/Evidence of Effectiveness: in silico analysis suggests that this test will cross react with SARS-CoV, but it is not circulating. LOD varies from 1.25-4.167 copies/uL depending on machine used (n=20). Performed wet lab tests on likely similar or same circulating area pathogens, found no likely crossreactivity. [8]
Complimentary Products Needed to Perform Test: Kit provides: multi-oligo mix, enzyme, buffer, positive control, internal control, and Rnase-free water. Still required: sample collection and preservation instruments/buffers, standard laboratory equipment, RNA extraction reagents, and RT-PCR detection systems [8]
Setting of Care: Authorized setting H [2]
Current Status / Clinical Development Stage / Expected Milestones: 1/19 South Korean companies approved for export of PCR reagents [5]
Funding & Ownership : privately owned [6]
Business Model: Creates and markets medical diagnostic kits and automated instrumentation for labs and hospitals [3]
IP: eerything on website is copyrighted, and kit website says ‘not available for sale in USA’ [7]
History & Origins : Company has background in medical diagnostics specifically in infectious disease [3]
Date EUA Issued: 4/21/2020 [2]
Sources: [1] http://www.seegene.com/global_networks [2] https://www.fda.gov/medical-devices/emergency-situations-medical-devices/emergency-use-authorizations#covid19ivd [3] http://www.seegene.com/company [4] http://www.seegene.com/our_history [5] http://www.koreabiomed.com/news/articleView.html?idxno=7953 [6] https://www.crunchbase.com/organization/seegene#section-overview [7] http://www.seegene.com/assays/allplex_2019_ncov_assay_us [8] https://www.fda.gov/media/137178/download [9] https://www.bloomberg.com/profile/person/16879422
Organization: Jong-Yoon Chun (CEO) [9]
Time to Result: 2 hour runtime, plus prep time
Test Sample Type: sputum, nasopharyngeal swab, oropharyngeal swab, anterior nasal swab, mid-turbinate [7]
Technology Overview: RT-PCR test that targets three genes: N gene, RdRp gene, and E gene. Has different fluorophores for each gene so can differentiate [7]
Testing Type: RT-PCR [2]
Test Category: RT-PCR
Test Name: Allplex 2019-nCoV Assay [2]
Clinical Application & Need: detect current infection from nasal swab, sputum, or mid-turbinate [7]

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