检验试剂之发展.ppt

檢驗試劑之發展 溫國蘭 博士 永昕生物醫藥股份有限公司 Apr. 30,2002 大綱 檢驗試劑研發歷史 全球IVD市場分析 免疫檢驗試劑介紹 檢驗試劑未來發展方向 檢驗試劑與生物藥發展的關係 Directive 98/79/EC Definition of An In Vitro Diagnostic Medical Device Means any medical device which is a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, equipment, or system Whether used alone or in combination, intended by the manufacturer to be used in vitro for the examination of specimens, including blood and tissue solely or principally for the purpose of providing information : concerning a physiological or pathological state, or concerning a congenital abnormality, or to determine the safety and compatibility with potential recipients, or to monitor therapeutic measures. 全球體外檢驗試劑 (IVD)市場規模與成長預估 檢驗試劑之未來方向 診斷技術提昇:Genomic vs. Proteomics 儀器技術提昇:電子, 網路, 自動儀技術與檢驗試劑開發相結合，更擴充檢驗試劑產品之領域及其應用 人類知的需求度提昇: POC及OTC市場值大增 人類壽命延長:保健及老年檢測增加 Non-invasive detection 食品衛生, 環境毒素之檢測量提昇 Genome Project之影響 核酸檢測相關產品可取代傳統微生物培養檢驗法: 可取代近20%, 檢驗市場超過10億美元 Human Genome Project已完成DNA定序之working draft. 衍生: DNA Chip 瓶頸: target ? Time ? Nucleic Acid Testing 舉例 Myriad Genetics : detect MLH1 and MSH2 genes: inherited in colon cancer and uterine cancer. Procyon: Colopath ? : DNA in stool in rectal mucous sample Alzheimer disease: Chromosome 10 defection Proteomics Proteomics: important role in drug discovery, molecular diagnostics and practice of medicine in then post-genomic era Current market value: 2 billion and will increase to 6 billion at 2005 and 10 billion at 2010 衍生:試劑種類增加,protein chip 產生 瓶頸 S/N ratio? Targets? Proteomics Luminex Corp : LabMAP ? found 300 components in disease in blood sample Proteomics in cancer markers---Matritech 食品衛生及環境檢測 75 million US citizens get ill from food poisoning, 325000 hospitalized and 5000 died. Detection of Samonella , E. Coli , campylobactor Detection of drug residues: antibiotics: sulfa drugs, b-lactam…etc. (WTO) Veterinary diagnosis: FMDV, pet-diagnosis Detection of environmental toxins: dioxane, pesticide