杭州優思達生物技術有限公司是由美籍華裔科學家尤其敏博士和胡林博士共同創立,于2005年01月28日在杭州注冊成立。
優思達是一家致力于創新快速分子診斷產品研發、生產和銷售的高新生物科技公司。公司總部和生產基地都位于杭州濱江區高科園區,其中生產廠房2000平方米,包括800平方米的10萬級潔凈區,并通過 ISO9001:2003, ISO13485:2003+AC:2007體系認證。公司擁有多項自主知識產權和數個快速分子檢測技術平臺,其中包括:微生物(DNA/RNA)檢測技術平臺、SNP/基因突變檢測技術平臺以及臨床鑒別診斷(Multiplex-Tests)檢測技術平臺,并已在此平臺上開發了多種新型快速分子診斷試劑盒。優思達的創新技術包括微量核酸提取技術、恒溫擴增技術、全封閉式靶核酸核酸擴增物快速檢測技術和試劑玻璃化技術和SNP/基因突變檢測技術等。將這些技術融合為一而形成的平臺使分子檢測和診斷擺脫了對昂貴設備和分子實驗室的依賴,讓分子檢測能方便、快速地在各級醫療、疾控和檢測機構得以應用,尤其適合基層醫院、發展中國家、及現場環境下的檢測。
優思達分子檢測平臺具有廣泛的臨床和工業應用前景,包括各級臨床醫院檢驗科、CDC實驗室的病原微生物檢測、檢驗檢疫中的衛生檢疫和動植物檢疫的致病原和有害生物的檢測、重大傳染病和突發公共衛生事件防控、制藥領域腫瘤藥物研發、臨床和治療中作為"伴隨診斷"(Companion Diagnostics)的突變基因和"生物標志物"的研究、開發和檢測等。
目前,優思達已經開發出系列病原菌檢測試劑盒和病毒耐藥基因檢測試劑盒,包括結核、性病、肝炎等領域。其中結核檢測技術獲得WHO新技術推薦。同時,我們和國際知名的非政府組織FIND、PATH,以及中國的多個科研機構和臨床單位合作進行重大專項課題和研究,取得了階段性成果。我們正不斷努力在不久的將來將優思達打造成世界級的分子診斷公司。
Ustar Biotechnologies (Hangzhou) Ltd. is an innovative molecular diagnostic company funded by the private sector. It was founded in 2005 by scientists from the US with the express goal of commercializing cutting-edge molecular technologies for the point-of-care.
The company's main office and manufacturing facilities are located in Binjiang District, Hangzhou, China. The new 2,000 square meter facilities includes a 800 square meters 100K grade clean room area, with a designed production capacity of 20 million tests per year. The facility is constructed and equipped with state-of-the-art technology and is ISO9001:2003, ISO13485:2003 + AC: 2007 certified. Ustar owns a number of proprietary technologies including instrument-free nucleic acid extraction, isothermal amplification and rapid DNA amplicon detection device which form two unique nucleic acid testing platforms: microbe detection and SNP/Mutation detection. The company developed a series of isothermal amplification testing kits based on the two platforms for clinical use as well as disease control. The customer benefits of these products include accuracy, ease-of-use, and low-cost, instrument-free, and cross-contamination proof testing.
The application outlook of Ustar molecular testing platforms is promising in both the clinical and industrial field. Clinicallyit can be used for rapid, convenient and low-costpathogen and SNP/mutation detection as a "companion diagnostic" or microbe genotyping tool for personalized medicine; industrially it can be used within R&D and clinical studies for pharmaceutical agentdevelopment. So far Ustar Biotech has developed several isothermal amplification kits for pathogen detectionand genotyping, including tuberculosis, sexual transmitted diseases and HBV genotyping. The NATeasy? Isothermal Amplification TB Detection Kitis listed asan Innovative technology recommended by the WHO. Ustar has also entered collaborations with renowned non-government organizations such as FIND,PATH in developing and evaluating newtestingkits,andwith a number of Chinese research and clinical institutions on a number ofsignificant healthcareprojects..
Ustar's vision is to become a leading company in commercializing molecular diagnostic assays for point-of-care use and resource-limited settings, bridging the gap between the advances in science/technology and the populations who are in need.