Fosun Pharma

Business Name:
Fosun Pharma
Business Genre:
Business Description:

Fosun is a publicly traded Chinese company that specializes in pharmaceuticals and diagnostics (including hepatitis B, HPV, and influenza) [1,4]

Data/Evidence of Effectiveness:
“• Inclusivity: aligned primer with “1119 publicly available sequences of SARS-CoV-2 from NCBI and GISAID” • Cross-reactivity: in silico or wet lab testing of “common respiratory flora and other viral pathogens from the same genetic family as SARS-CoV-2” • Clinical Validation: contrived positive and negative samples (n=32-35), comparing results to the CDC EUA approved test (n= 50 positive and 100 negative patients and 100% agreement), and comparing results to an approved kit (n=204 positive samples and 393 negative samples and 92-100% agreement depending on sample type) [6]”
Complimentary Products Needed to Perform Test:
“• RNA extraction kit (QIAamp® Viral RNA Mini Kit) • Applied Biosystems 7500 RT-PCR machine • Consumables: 96 well plates, plastic film to cover plates, pipette tips with filters, microcentrifuge tubes • Basic laboratory supplies: centrifuge, vortex, pipettors [6]”
Setting of Care:
“Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments (CLIA) of 1988, 42 U.S.C. §263a, to perform high complexity tests.” [2]
Current Status / Clinical Development Stage / Expected Milestones:
“””This test has not been FDA cleared or approved; This test has been authorized by FDA under an EUA for use by authorized laboratories”” [6]”
Funding & Ownership :
Public IPO [2] with Market cap of 10.8B [3]
Business Model:
Fosun sells pharmaceuticals and diagnostics (including hepatitis B, HPV, and influenza) [1,4]
History & Origins :
Fosun is an established company that already manufacters several diagnostics (including hepatitis B, HPV, and influenza) [1,4]
Date EUA Issued:
4/17/2020 [5]
[1] [2] [3] [4] [5] [6] [7] [8]
Fosun is led by a Board of Directors, whose chairman is Chen Qiyu [7]
No. Tests Per Day:
24 hours/day / 3 hours/run= 8 runs/day. 94 samplesx8 runs/day =752 samples/day
Time to Result:
1 hour and 20 minutes of amplification [2], but with RNA extraction, PCR setup, and analysis, probably around 3 hours
Test Sample Type:
anterior nasal swabs, mid-turbinate nasal swabs, nasopharyngeal swabs, oropharyngeal swabs, sputum, lower respiratory tract aspirates, bronchoalveolar lavage, and nasopharyngeal wash/aspirate or nasal aspirate [2]
Technology Overview:
detects presence of RNA originating from SARS-CoV-2 in samples using a multiplexed RT-PCR using 3 primers: ORF1ab, N gene, and E gene [2]
Testing Type:
qualitative viral RNA test [2]
Test Category:
Test Name:
Fosun Covid-19 RT-PCR Detection Kit [2]
Clinical Application & Need:
Detect SARS-CoV-2 RNA during acute infection [2]
Age of Company:
1994 [8]

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