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

SEASUN Biomaterials

Business Name: SEASUN Biomaterials
Business Genre:
Business Description:

Founded 2012, focus in diagnostic materials and DNA testing (cancer and genetic disorder testing), certified by CDC in 2015 and approved by South Korea’s national health insurance list [1]

City: ro, Yuseong-gu
State: Daejeon
Country: Korea
Data/Evidence of Effectiveness: Limit of detection is 1 genomic RNA copy/uL in serial dilutions of negative nasopharyngeal and sputum samples spiked with SARS-CoV-2 RNA (n=20). Used Blastn in sillico and tested in vitro (n=3) against common upper respiratory viruses and bacteria [3]
Complimentary Products Needed to Perform Test: kit provides: 2x reaction buffer, enzyme mix, reaction mix, positive control, negative control. Still required: viral sample collection kit or universal viral transport system, sputum collection container, RNA extraction kit, RT-PCR system+consumables (CFX 96 RT-PCR detection system (Bio-Rad) or Applied Biosystems RT-PCR system 7500), general laboratory equipment (96-well plate, sealing film, vortex and microcentrifuge, sterilized pipette tips, microfuge tubes, disposables gloves and lab gown [3]
Setting of Care: Authorized setting H [2]
Current Status / Clinical Development Stage / Expected Milestones: Authorized under EUA on 4/27/2020 [2] Currently distributed overseases to Europe and Middle East at 200,000 kits/day [4] 1/19 companies approved for export of PCR agents [5]
Funding & Ownership : privately owned [8]
Business Model: Develops RT-PCR based diagnostic kit and protocols and commercializes them, for screening for cancer or genetic disorders, and infectious diseases. Has a third-party distributor called Datametrex that has sales rights [6]
IP: kit and manual are proprietary [7]
History & Origins : Company focuses on designing and commercializing RT-PCR kits and protocols [1][6]
Date EUA Issued: 4/27/2020 [2]
Sources: [1] http://www.seasunbio.com/english/company.html#tab01 [2] https://www.fda.gov/medical-devices/emergency-situations-medical-devices/emergency-use-authorizations#covid19ivd [3] http://www.seasunbio.com/english/images/pdf/IFUU-TOPCOVID-19DETECTIONKIT.pdf [4] https://www.prnewswire.com/ae/news-releases/seasun-biomaterials-to-launch-covid-19-rapid-molecular-assay-896502248.html [5] http://www.koreabiomed.com/news/articleView.html?idxno=7953 [6] https://www.bloomberg.com/press-releases/2020-05-06/datametrex-obtains-rights-to-sell-covid-19-tests-from-two-additional-south-korean-manufacturers [7] https://finance.yahoo.com/news/seasun-biomaterials-launch-covid-19-130000788.html [8] https://craft.co/seasun-biomaterials/metrics
Organization: CEO: HeeKyung Park [1]
Time to Result: 3400 samples /12 hours [6]
Test Sample Type: oropharyngeal and nasal pharyngeal swab, anterior and mid-turbinate nasal swabs, nasopharyngeal wash/aspiate, nasal aspirate, or sputum [3]
Technology Overview: targets two regions in ORF1ab and the N gene (three total targets), uses peptide nucleic acid (PNA) probes rather than just a dye [3], so each gene and the controls are detected at different wavelengths
Testing Type: RT-PCR [2]
Test Category: RT-PCR
Test Name: U-TOP COVID-19 Detection Kit [2]
Clinical Application & Need: detect current infection from upper respiratory swab or sputum [3]

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