OSANG Healthcare

Business Name:
OSANG Healthcare
Business Genre:
Business Description:

Founded in 1996, South Korea-based company that produces diagnostic biosensors for the measurement of blood biomarkers and sensors for disease like heart disease, cancer, with the goal of medical devices “becoming as commonplace as home appliances” [2] Partnered with SG Blocks for distribution in the US [4]

Republic of Korea
Data/Evidence of Effectiveness:
LOD confirmed at 10 RNA genomic copies/reaction, or 2 copies/uL. Tested for cross-reactivity against 20 other respiratory viruses, and found ‘inclusivity’ with SARS-coronavirus. Mucin, blood, respiratory syncytial virus A, and PBS were all tested and found to interfere at high concentrations but no issue at appropriate concentrations [3]
Complimentary Products Needed to Perform Test:
“Kit provides: reaction mixture, probe mixture, positive control, negative control. Still required: RT-PCR instrument, (“”Applied Biosystems® 7500 / 7500 Fast Real-Time PCR Instrument System or CFX96 Real-Time PCR system.””) general lab equipment, RNA isolation kit [3]”
Setting of Care:
Authorized setting H [1]
Current Status / Clinical Development Stage / Expected Milestones:
EUA approved 4/18/2020 [1]. Exports all of their test kits bc South Korea has enough, and have already exported 10 million kits during the pandemic.Claim to be ready to ship kits to test 100 million people to US, and have distributors in 25 states but states can’t get money to buy them [3]
Funding & Ownership :
privately owned [5]
Business Model:
produces and sells diagnostic sensors for clinic and home use. Main product is blood-glucose sensors for at-home testing but produces cancer and infectious disease tests as well. [2]
everything on website is copyrighted [2]
History & Origins :
Company has experience in producing infectious disease diagnostics tests [2]
Date EUA Issued:
4/18/2020 [1]
[1] [2] [3] [4] [5]
CEO/Rep Director: Lee Dong-Hyeon. CTO: Lee Geuk-Rae. Senior Managing Director: Yoo Beong-Yoel [5]
Time to Result:
1.5 hour runtime, plus prep time [3]
Test Sample Type:
repiratory specimens’, but specifically sputum, bronchoalveolar lavage fluid, and nasopharyngeal swab [3]
Technology Overview:
RT-PCR test that targets three genes: N gene, RdRp gene, and E gene, uses different fluorophore probes so each gene can be individually detected [3]
Testing Type:
RT-PCR [3]
Test Category:
Test Name:
GeneFinder Covid-19 Plus RealAmp Kit [1]
Clinical Application & Need:
detect current infection from nasal swab, lavage fluid, or sputum sample [3]

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