杭州优思达生物技术有限公司是由美籍华裔科学家尤其敏博士和胡林博士共同创立,于2005年01月28日在杭州注册成立。
优思达是一家致力于创新快速分子诊断产品研发、生产和销售的高新生物科技公司。公司总部和生产基地都位于杭州滨江区高科园区,其中生产厂房2000平方米,包括800平方米的10万级洁净区,并通过 ISO9001:2003, ISO13485:2003+AC:2007体系认证。公司拥有多项自主知识产权和数个快速分子检测技术平台,其中包括:微生物(DNA/RNA)检测技术平台、SNP/基因突变检测技术平台以及临床鉴别诊断(Multiplex-Tests)检测技术平台,并已在此平台上开发了多种新型快速分子诊断试剂盒。优思达的创新技术包括微量核酸提取技术、恒温扩增技术、全封闭式靶核酸核酸扩增物快速检测技术和试剂玻璃化技术和SNP/基因突变检测技术等。将这些技术融合为一而形成的平台使分子检测和诊断摆脱了对昂贵设备和分子实验室的依赖,让分子检测能方便、快速地在各级医疗、疾控和检测机构得以应用,尤其适合基层医院、发展中国家、及现场环境下的检测。
优思达分子检测平台具有广泛的临床和工业应用前景,包括各级临床医院检验科、CDC实验室的病原微生物检测、检验检疫中的卫生检疫和动植物检疫的致病原和有害生物的检测、重大传染病和突发公共卫生事件防控、制药领域肿瘤药物研发、临床和治疗中作为"伴随诊断"(Companion Diagnostics)的突变基因和"生物标志物"的研究、开发和检测等。
目前,优思达已经开发出系列病原菌检测试剂盒和病毒耐药基因检测试剂盒,包括结核、性病、肝炎等领域。其中结核检测技术获得WHO新技术推荐。同时,我们和国际知名的非政府组织FIND、PATH,以及中国的多个科研机构和临床单位合作进行重大专项课题和研究,取得了阶段性成果。我们正不断努力在不久的将来将优思达打造成世界级的分子诊断公司。
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.