Company Profile
Overview
Hangzhou Ustar Biotechnologies Co., Ltd. was founded in 2005 and has been dedicated to the research, development, production, and sales of innovative point-of-care molecular diagnostic (POCT) technologies and products.
Ustar has developed a comprehensive molecular POCT solution covering clinical diagnostics, diseases prevention and control, and agricultural and livestock quarantine. In the future, its reagent pipeline will be expanded from pathogen diagnostics to autoimmune diseases, tumor mutations, and pharmacogenetics
Ustar Technology
Global Recognition
The company has obtained NMPA Class III medical device certification for 2 devices and over 10 reagents, CE IVDR certification for over 10 reagents, and multiple devices and reagents have received ANVISA, TGA, HSA, and other international certifications. Notably, its PortNAT and EasyNAT molecular POCT monkeypox nucleic acid detection reagents have been included in the World Health Organization (WHO) Emergency Use Listing (EUL).
Ustar's History
Ustar Biotechnologies founded
2005
The Cross Priming Amplification (CPA) technology was granted a patent
2008
Participated in the major national science and technology projects of the “11th Five-Year Plan” and began to undertake national-level projects
2009
Undertook a sub-project under the National “12th Five-Year Plan” Major Science and Technology Program
2012
The tuberculosis detection kit (isothermal amplification–test strip method) was approved for market release.
Received investment from the Bill & Melinda Gates Foundation.
2014
Awarded the Second Prize of the National Science and Technology Progress Award.
2017
The innovative medical devices — nucleic acid amplification analyzer and rapid tuberculosis detection kit — were approved for market release.
Undertook the National “13th Five-Year Plan” Major Science and Technology Project for Infectious Diseases.
2019
The COVID-19 rapid test kit was included by the Ministry of Science and Technology as part of the major national project for emergency and rapid nucleic acid testing and was soon approved for market release.
Honored with the title of “Advanced Collective in Hangzhou’s Fight Against COVID-19.”
2020
Received the first EU CE certificate for nucleic acid self-testing;
CT/NG nucleic acid test kits were approved for market release and obtained the MDSAP certificate.
2022
The fully automated medical PCR analyzer was approved for market release；
Received China’s first TÜV SÜD molecular diagnostics IVDR certificate;
Received clinical evaluation support worth USD 9 million from FIND and the Stop TB Partnership.
Influenza A & B and Mycoplasma pneumoniae (MP) test kits were approved by NMPA
2023
RSV test kits approved by NMPA
2024
Monkeypox Virus Test kits certified by WHO Emergency-use-list (EUL)
2025
Enterprise Culture
Expanding innovation across the globle, delivering solutions worldwide.
Ustar’s products and technologies have served more than 3,000 medical institutions and have been exported to over 90 countries, actively contributing to global efforts in combating major infectious diseases such as tuberculosis.
