Sansure Biotech

Business Name:
Sansure Biotech
Business Genre:
Business Description:

The company is based in China and was founded in 2008. The comopany manufatured a complete product line for molecular diagnostics, including nucleic acid extraction kits and fully automated RT-PCR machines. The company focuses on the diagnostics of virus infection and cancer. [2][3]

Data/Evidence of Effectiveness:
Non-clinical experiments indicate the 95% hit rate of the product is 200 copies/ml. No cross-reactivity is observed in in-vitro experiments, while in silico analysis predicts possible detection of bat coronaviruses pangolin coronaviruses. In clinical evaluation of 246 samples, the positive agreement rate is 94.34% and negative agreement rate is 98.69% [5]
Complimentary Products Needed to Perform Test:
“Included in the kit: sample-release reagent, 2019-nCoV-PCR mix, 2019-nCoV-PCR enzyme mix 2019-nCoV-PCR positive/negative control, sample storage reagent Not included in the kit: swab with synthetic tips, extraction can be done with alternative kit Qiagen QIAamp Viral RNA Mini Kit [5]”
Setting of Care:
only used under EUA by trained laboratory personnnel in the techniques of RT-PCR and in vitro diagnostics [5]
Current Status / Clinical Development Stage / Expected Milestones:
The product is under CE-IVD, NMPA, FDA-EUA certification and is one of the first six testing kits approved in China. News reported a daily production capacity of 500,000 test kits of Sansure in April. The product was commercially available on March 16 in US with updated guidance before EUA approval in May. Sansure Biotech has distributed the product to over 40 countries and regions. [7] [8]
Funding & Ownership :
Private, total funding amount $77M; Lead investors are Lily Asia Ventures (venture capital investments in Asia for Eli Lilly and Company) and Highlight Capital (Asia-Pacific investment firm) [9] [10] [11]
Business Model:
sales of PCR-based nucleic acid detection products for molecular diagnostics, including the one-tube technology platform, new magnetic-bead technology platform, automated liquid-handing technology platform.
History & Origins :
The company manufactures a completed product line for PCR-based molecular diagnostics in virus infection and cancer. The company was recently listed on China’s Nasdaq-Like Star Board in May due to its massive sales of CoV-19 testing products. [13]
Date EUA Issued:
5/4/2020 [4]
“[1] [2] [3] [4] [5] [6] [7] [8] [9] [10] [11] [12] [13]”
“Dai Lizhong( Chairman/President); Zhou Jun (VP/Chief Medical Officer); Peng Zhu (VP/Secretary/Controller/IR) [12]”
Time to Result:
Automated 96-sample output in 3.5 hours, 30min per sample with Sansure iPonatic portable working station [3] [6]
Test Sample Type:
nasopharyngeal swabs, oropharyngeal (throat) swabs, anterior nasal swabs, midturbinate swabs, nasal washes and nasal aspirates [5]
Technology Overview:
detection of the ORF1ab and N genes of SARS-CoV-2 RNA [5]
Testing Type:
real-time RT-PCR detection for SARS-CoV-2 nucleic acid[5]
Test Category:
Test Name:
Novel Coronavirus (2019-nCoV) Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)
Clinical Application & Need:
acute/latent infection

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