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

Maccura Biotechnology

Business Name:
Maccura Biotechnology
Business Genre:
Business Description:

The China-based company was founded in 1994. Maccura Biotech focuses on the development and manufacture of IVD products in the field of biochemistry, POCT, hematology, immunoassay and pathology. [2]

State:
Chengdu
Country:
China
Data/Evidence of Effectiveness:
The lowest limit of detection tested with the kit is 1000 copies/ml (100% positivity). In silico analysis indicates no cross-reactivity with other respiratory pathogens. 30 positive/negative clinical samples have been tested to evaluate its performance. The positive result agreement is 100% and negative result agreement is 96.7% [4]
Complimentary Products Needed to Perform Test:
Nucleic acid extraction kit [4]
Setting of Care:
permitted use under EUA in authorized laboratories [4]
Current Status / Clinical Development Stage / Expected Milestones:
Maccura Biotech is one of the six companies officially selected by Chinese government to supply testing kits for Hubei Province (including Wuhan). The products are also exported to EU and other areas in Asia. [5] [6]
Funding & Ownership :
Public (Market Cap 28.29 billion CNY) [8]
Business Model:
In addition to CoV-19 testing kits, the company also provides reagents for clinical metabolite testing. The company also develops point-of-care testing devices for infectious diseases, digestive diseases and diabetes management. [7]
IP:
N/A
History & Origins :
The company has extended experiences in development of clinical IVD reagents, products and service. Maccura Biotech joined IFCC in 2010 as the first Chinese enterprise member. The research center of the company has also undertaken several national industrial research projects in collaboration with the Chinese government. [2] [9]
Date EUA Issued:
04/15/2020 [3]
Sources:
[1] https://www.crunchbase.com/organization/maccura#section-overview [2] https://www.maccura.com/en/about/jAEA2OQdXAE-.html [3] https://www.fda.gov/medical-devices/emergency-situations-medical-devices/emergency-use-authorizations [4] https://www.maccura.com/resources/98099844450617886.pdf [5] http://www.globaltimes.cn/content/1188161.shtml [6] https://www.maccura.com/en/product/vAMA7UmFXAE-.html [7] https://www.maccura.com/en/product/index.html [8] https://www.msn.com/en-us/money/stockdetails/fi-adewr7?symbol=300463&form=PRFIHQ [9] https://www.maccura.com/en/about/jwEA2OQdXAE-.html [10] https://www.bloomberg.com/quote/300463:CH
Organization:
Yong Tang (Chairman), Mingjian Wu (President) [10]
Time to Result:
Automated 96-sample output in 3.5 hours on recommended Applied Biosystems 7500 Fast Dx Real-Time PCR Instrument [4]
Test Sample Type:
respiratory specimens (nasopharyngeal swabs, oropharyngeal swabs, nasal swabs, and mid-turbinate swabs) [4]
Technology Overview:
PCR amplification for CovV-19 ORF1ab, N and E genes, with MS2 based pseudo-virus containing internal/positive control RNA [4]
Testing Type:
nucleic acid detection
Test Category:
RT-PCR
Test Name:
SARS-CoV-2 Fluorescent PCR Kit
Clinical Application & Need:
acute infection

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