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] [2] [3] [4] [5] [6] [7] [8]
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]

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