Colosafe™ coloretectal cancer DNA screening test kit


Colosafe™ coloretectal cancer DNA screening test (fluorescence PCR method) has passed CE certification and is used for early colorectal cancer screening.
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HymonBio Co., Ltd.About HymonBio Co., LtdHymonBio Co., Ltd was established in 2015, with co-founders returning from the University of Texas and Chinese Academy of Sciences. The company focuses on the development, production, and sale of precision-medicine and point-of-care (POCT) related products. Since its establishment, the company has carried out scientific research and clinical cooperation with a number of scientific research institutes and medical institutions, and hired authoritative experts in the field of medical testing, both at home and abroad, to establish a consulting team to provide professional technical and scientific research support for the company’s product development.Since its establishment in Taicang Port, HymonBio has applied for 18 patents and obtained 6 authorized patents; 11 products have obtained Chinese medical device certificates; 2 products have obtained EU CE certificates; 1 product has obtained an FDA certificate and passed the ISO13485 system certificate. The company has won awards such as high-tech enterprises, private technology enterprises in Jiangsu Province, enterprises supported by the "Double Innovation Plan" of Jiangsu Province, Suzhou Female Innovation and Entrepreneurship Leading Talent Enterprises, Taicang Innovation and Entrepreneurship Leading Talent Enterprises, and Taicang City Entrepreneurship Pioneer Enterprises.For the past 10 years, the founding team of HymonBio experienced many epidemic situations. After the outbreak of new infectious diseases, it provided emergency research and development tasks for the front-line fight against the epidemic, including H1N1, H7N9, etc. The co-founders of the company have also served as the project leaders of sub-projects of major national special infectious diseases and have special occupational sensitivity to emerging infectious diseases.After the outbreak of COVID-19, the “one-step” HymonTM SARS-CoV-2 Test Kit was developed by the HymonBio team, which can be used for the screening of infected people, monitor diagnosis and treatment, determine negative results, etc. The kit effectively solves the cumbersome problem of nucleic acid extraction steps by using a single tube for extraction, allowing the nucleic acid to be release in 4 minutes, and shortening detection time to 35 minutes.Based on MoLock nano-antibody molecular lock technology and OT buffer system technology, detection sensitivity can reach 200 copies per milliliter, with 100% specificity. It also has a dual internal standard design to monitor the whole process, from sampling to detection, effectively avoiding false negative and false positive results. There have been no complaints in the world so far. This product has passed quality evaluations of many major clinical institutions at home and broad, including: Shanghai Clinical Testing Center, Jiangsu Medical Device Inspection Institute, American Reference Laboratory, Kenya National Laboratory, etc., and was approved by the US Food and Drug Administration Emergency Use Authorization certification, the European Union CE certification, and other national qualification certifications. Its fast and efficient detection performance has been praised by more than 30 overseas English and Spanish media, and has been recommended by Dr. Stephen M. Hahn, director of the FDA. The product has been verified by the United States FDA Department of Microbiology and Devices, the British King’s College Hospital NHS Foundation, the Chinese National Health Commission Clinical Laboratory Center, and the Hong Kong Polytechnic University Laboratory affiliated with the Hong Kong Department of Health. It can detect 100% of the variants of COVID-19 Alpha, Beta, Gamma, Delta, etc.In June 2021, HymonBio Co., Ltd. signed an equity investment agreement with PerkinElmer Ventures, a leading company in the IVD industry in the United States, marking that HymonBio has officially completed the first round of financing and entered a new lane of capital market development.