2012-05-012024-05-14https://scholars.lib.ntu.edu.tw/handle/123456789/660592摘要：國家轉譯醫學與臨床試驗資源中心(NTCRC)的任務是為執行生技醫藥國家型計畫(NRPB)臨床試驗與轉譯醫學研究提供必要的協助，其中，子計畫三(TR6-3)轉譯核心實驗室(TCL)是一個目標導向的參考實驗室。為符合NRPB 計畫的研究人員的需求，我們於去年建立了參考實驗室，為研究者發起的臨床試驗和其他從事轉譯醫學研究的同仁提供標準與客製化的基因檢測服務。此參考實驗室的目標有二，第一、提供常規基因檢測服務：TLC 將為從事新藥、新體外試劑或新醫療儀器確效評估的NRPB 研究者提供與優化常規基因檢測。第二、依照NRPB 的研究人員需求提供客製化服務：TCL將為上述人員研發新的基因檢測平台。在過去的九個月中，TCL 已有豐碩的執行績效。第一、我們針對EGFR 突變研發了高靈敏度的基因檢測，成果已發表於2011 年的Journal of Clinical Oncology，同時亦將此檢測提供臨床試驗之用，健保局已採納我們的檢測報告，並依此給付分子標靶藥物的健保藥費。第二、服務收入達新台幣15,030,000 元。第三、TCL 分別針對SNP 基因分型、基因拷貝數偵測與肺結核偵測提供了客製化基因檢測服務。第四，TCL 有五人次取得ISO17025 的資格，十三人次分別取得ISO15189 醫學實驗室、ISO15189 醫學實驗室主管、ISO15189 測試主管、與ISO15189 內部稽核的資格。TCL 將於第一年結束前提出ISO15189 的實驗室認證申請。在第二年的計畫中，TCL 將提供三項新的服務。第一、為NRPB 第一期臨床試驗聯盟提供OncoCarta 基因突變圖譜分析。第二、肺結核分子診斷與抗藥性偵測。第三、SNP 基因分型服務。TCL 亦將致力於研發DNA 甲基化定量、基因突變定量與非侵入性基因檢測。經過本計畫的努力，我們預期TCL 將可達成本整合型計畫的目標-藉由轉譯醫學研究與臨床試驗計畫，將可加速NRPB 開發的新藥與生技發明成功地商品化成為醫療產品的速度。<br> Abstract: The mission of National Translational Medicine and Clinical Trial Resource Center(NTCRC) is to provide necessary support for clinical trials and translational medicinestudies initiated by investigators of National Research Program for Biopharmaceuticals(NRPB). The component project 3 (TR6-3), Translational Core Laboratories (TCL) ofNTCRC, is a direction-oriented reference laboratory. To meet the needs of NRPBresearchers we have established TCL to provide the standard gene tests and customizedgene tests for PI-initiated clinical trials as well as requests from NRPB R&D groups,NRPB core facilities and translational research groups last year. The specific aims of TCLare: First, Providing the well-established gene tests: we will provide and optimize thewell-established gene tests for NRPB researches focusing on assessment of newdrug/medical device efficacy, evaluation of new IVD (in vitro diagnosis kit) accuracy, andso on. Second, Developing the customized gene tests based on PI requirement: we willdevelop the new assays for currently unavailable gene tests for evaluation of new drugtargets, new therapeutic manipulations, new IVD and so on. In the past nine months, wehave fruitful achievements 1. We develop a high sensitive gene test platform for EGFRmutation detection. The result was published on Journal of Clinical Oncology this yearand we provide this gene test for clinical trials. Bureau of National Health Insuranceaccepts our medical reports and bases on our gene test result to fund the fee of moleculartargeting drug. 2. The service income is NT 15,030,000. 3. We are provided threecustomized designed service for clinical trials or translational medicine studies for SNPgenotyping, gene copy number detection and TB detection. 4. We have five person-timescertificated by TAF (Taiwan Accreditation Foundation) ISO17025 and 13 person-timescertificated by TAF ISO15189 for Medical Laboratory training, Head of MedicalLaboratory, Head of Testing Laboratory or Internal Auditor training. We will applyISO15189 accreditation before the end of first funded year. In the second year proposal,we will provide three new service items 1. Somatic Mutation Profiling (OncoCarta™Cancer Panels) for NRPB phase I consortium. 2. TB Identification and Drug ResistanceDetection. 3. SNP Genotyping by Illumina BeadXpress System. We will be devoted todevelop 1. Quantitative DNA Methylation Analysis, Quantitative DNA Mutation Test andLess-invasive Gene Testing by Personal Genome Machine. After our efforts, we expectthat TCL can reach the OBJECTIVES of this general project to support and to speed upthe development of NRPB innovative drugs and biotech inventions into successfulcommercial medical products through translational research and clinical trials.轉譯醫學新藥開發體外試劑臨床試驗Translational MedicineDevelopment of New DrugIVDClinical Trail