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

SD Biosensor

Business Name:
SD Biosensor
Business Genre:
Business Description:

Republic of Korea-based company that produces immunological and molecular diagnostics biotech and has locations in South Korea, India, and China [1]

City:
Yeongtong-gu
State:
Gyeonggi-do
Country:
Republic of Korea
Data/Evidence of Effectiveness:
Limit of detection is 0.5 genomic RNA copies/uL for upper and lower respiratory samples, varies slightly by RT-PCR machine [5]. Tested both in silico and in vitro organisms and found no cross-reactivity, didn’t say why they picked the specific organisms but could be assumed they are common in the repiratory tract (other coronaviruses, influenza, tuberculosis, etc) [5]
Complimentary Products Needed to Perform Test:
nasal swab, general laboratory equipment, thermal cycler (LightCycler 480 (Roche), CFX96 Dx System (Bio-Rad), Applied Biosystems 7500 Real-Time PCR Instrument System (Thermo Fisher Scientific)) [2]
Setting of Care:
Authorized setting H [3] (clinical lab [2])
Current Status / Clinical Development Stage / Expected Milestones:
Authorized under EUA on 4/23/2020 [3]. US FDA ordered 300,000 kits in mid-April [6].
Funding & Ownership :
privately owned by investors [7]
Business Model:
Produce molecular diagnostics tests for infectious and accute diseases, provide genetic testing services [1]
IP:
data not available
History & Origins :
This company has a history of producing diagnostic tests either for infectious or chronic diseases as well as genetic testing services, so they have expertise in the diagnostics field [1]
Date EUA Issued:
4/23/2020 [3]
Sources:
[1] http://www.sdbiosensor.com/xe/companyInfo [2] http://www.sdbiosensor.com/xe/product/7653 [3] https://www.fda.gov/medical-devices/emergency-situations-medical-devices/emergency-use-authorizations#covid19ivd [4] http://www.koreabiomed.com/news/articleView.html?idxno=7953 [5] https://www.fda.gov/media/137302/download [6] https://edition.cnn.com/2020/04/13/politics/south-korea-coronavirus-tests/index.html [7] https://www.crunchbase.com/organization/sd-biosensor#section-overview [8] https://www.dnb.com/business-directory/company-profiles.sd_biosensor_inc.1620141583242034eea8204a8c8f759c.html
Organization:
President: Hyo Geun Lee [8]
Time to Result:
90 minutes (runtime), requires RT-PCR prep [2]
Test Sample Type:
nasopharyngeal swab, oropharyngeal swab, sputum [2]
Technology Overview:
targets RdRp (ORF1ab) and E gene os SARS-CoV-2, as according to WHO guidelines for lab testing [2]
Testing Type:
RT-PCR virus test [2]
Test Category:
RT-PCR
Test Name:
STANDARD M nCoV Real-Time Detection kit [2]
Clinical Application & Need:
detect current infection from nasal swab or sputum sample [2]

Send Message to listing owner

Leave A Reply