科技部新聞稿

科學預言師-基因檢測

科技部生技醫藥核心平台-藥物基因體實驗室

日期：108年12月11日

發稿單位：生命科學研究發展司

聯絡人：簡榮村 博士

電話：(02)2737-7990

E-mail：jtchien@nstc.gov.tw

隨著人類基因組計畫的完成與人類疾病大數據的快速累積，科學家們解開了人類的核心秘密，透過健康人與病患的基因比對，找出了其中的差異序列。時至今日，透過檢測自身是否存在不正常基因序列來診斷甚至預測罹患疾病的狀況與用藥指引。這就是科學家的預言方式-基因檢測。

在科技部生技醫藥核心平台(National Core Facility for Biopharmaceuticals)計畫(民國100年5月迄今)支持下，台灣大學醫學檢驗暨生物技術學系俞松良教授及其團隊建立了藥物基因體實驗室。計畫長程目標為建立一個符合世界級規範並包含「基礎科研-功能性基因體學研究」與「臨床應用-精準醫療檢測」的核心實驗室。透過1. 建置先進與完善的功能性基因體研究平台，2. 提供客製化醫學基因檢驗報告，3. 完善台灣生技產業價值鏈等三項策略，提供國內產學研界在基因表現及定序最專業的服務。此外，本實驗室也是國內學術界唯一的醫學認證實驗室(ISO15189醫學實驗室認證)，因應全球”精準醫療”的潮流，從設計，開發到醫學認證一站式服務，提供國內外生技產業及藥廠符合臨床醫療規範的基因檢驗，協助體外檢驗試劑開發與藥物臨床試驗，在台灣醫療生技開發上提供最堅強的技術支持。

本設施多元面向亮點如下：

善盡社會責任方面

本核心實驗室在推動台灣癌症精準診療不遺餘力，自2011年提供台灣三分之一以上肺癌病患EGFR標靶藥物所需的基因檢測，而團隊中任職台大醫技系的蘇剛毅副教授開發的核酸質譜儀（MALDI-TOF MS）突變基因高敏感度偵測平台於2013年獲ISO15189認證，至今，已提供超過25,000基因檢測報告，自2019年9月EGFR基因檢測納入健保，本實驗室完成提升台灣基因檢驗準確性的階段性任務後，已於2019年六月停止EGFR服務，並將研發能量轉進精準醫學基因檢測其他缺口。包括自2018年底本核心實驗室即提供全台肺癌標靶藥物治療所需之bRaf基因檢測以及針對實體瘤病患提供具醫學認證之二代測序多基因檢測報告協助臨床醫師進行治療。

促進經濟發展方面

本核心實驗室與許多國內外藥廠與生技廠合作開發用於癌症治療藥物指示的伴隨式診斷(companion diagnosis)，包括

1. < >EGFR T790M體外檢驗試劑，並申請食藥署查驗登記。< >PCR開發整合式癌症多基因體外檢驗試劑。< >(AstraZeneca)，羅氏醫療診斷(Roche Diagnostics) 等藥廠，進行癌症免疫治療的基因檢測評估與開發。< >2017年參與由中研院領導的國際癌症登月計畫，專責肺癌與乳癌的檢體製備與基因體定序，將快速縮短國內於癌症治療與精準醫學的國際差距。< >年與美國國家癌症研究所(National Cancer Institute, NCI) CLIA實驗室「甲狀腺球蛋白質譜定量」進行技術轉移並作為對接單位，為開展以蛋白質譜儀進行癌症蛋白標誌開發的先驅。< >2014年參與衛福部「以人口群為基礎之癌症研究-新興癌症篩檢研究：以低劑量電腦斷層掃描篩檢台灣不吸菸肺癌高危險群之研究」的五年計畫，負責檢體處理與基因檢測，並發現台灣肺癌與歐美的危險因子明顯不同。< >(ASU)技轉可程控蛋白晶片技術至台灣，建立新的生技產業聚落與生技產業鏈。

以基因檢測作為伴隨式診斷，已成為現在許多疾病治療的標準流程，藥物基因體實驗室致力開發”高準確度、高附加值及高需求度”的三高基因檢測。在科技部的支持之下，繼續為國人健康與台灣生技業貢獻一份心力。

藥物基因體實驗室 聯絡人

舒德仁博士

台灣大學醫學檢驗暨生物技術學系

聯絡電話：(02)23123456-88698

電子郵件信箱：g9255002@gmail.com
 

Press Release

December 11, 2019

The Scientific Prophet- Gene Testing

After the completion of the human genome project and the rapid accumulation of human disease data, scientists have unlocked the core secrets of humans, and found the different genome sequences between healthy people and patients. Diagnose, prediction and medication guidelines for the disease by detecting the abnormal gene sequences is the scientist's way of fortune-telling.

Under the support of the National Core Facility for Biopharmaceuticals program (MOST, R.O.C.), Prof. Yu, Sung-Liang and his team established the Pharmacogenomics Laboratory (TR6). The long-term goal for the core lab is to establish a world-class laboratory for both supporting "Basic Research of Functional Genomics Research" and developing "Clinical Applications of Precision Medicine." Through three strategies:  1. Establishing advanced and comprehensive functional genomics platforms, 2. Providing customized medical genetic test and report, 3. Improving Taiwan's biotechnology industry value chain with gene expression and the sequencing services. In addition, this lab is also the only medical certification laboratory (ISO15189 medical laboratory certification) in the domestic academia, and we are providing one-stop service from design and development to medical certification for domestic/foreign biotechnology industries and the pharmaceutical companies with the “clinical standard” genetic tests, assisting IVD development and clinical trials. We are powerful genomic technical support in Taiwan for both basic research and industrial development.

Contribution of this facility is as follows:

Social responsibility

This core facility has provided genetic testing for EGFR TKI for more than one-third of lung cancer patients in Taiwan since 2011, and Professor Su, Kang-Yi, another PI of the lab, developed ISO15189-certified Mass spectrometer (MALDI-TOF MS) mutated gene detection platform since 2013, has provided more than 25,000 gene test reports to date. Since the EGFR gene test was included in national health insurance in September 2019, the laboratory has stopped the EGFR gene testing service in June 2019. We completed the phased task of improving the accuracy of Taiwan's genetic testing, and transferred R&D energy into other gaps in gene testing. Now we are providing bRaf gene test and NGS multi-gene test report for solid tumor to assist clinicians in treatment.

Promotion of economic

TR6 lab cooperates with many domestic/ foreign pharmaceutical companies and biotechnology factories to develop the diagnostic methods and companion diagnosis in cancer drug indications, for example,

1. Cooperate with the local biotechnology company to develop the first liquid biopsy IVD of EGFR T790M in Taiwan for the 3^rd TKI of lung cancer, and apply for TFDA registration.

2. Cooperate with local instrument manufacturer to develop integrated cancer multi-gene IVD on Taiwan's self-developed digital PCR machine.

3. Cooperate with international pharmaceutical companies and biotechnology factories, such as AstraZeneca and Roche Diagnostics, in genetic testing development for cancer immunotherapy

Improving academic development

1. We participated in the international “cancer moonshot” project in 2017 with Academia Sinica, specializing in the sequencing of the cancer genome, which will quickly shorten the gap in cancer research and precision medicine between Taiwan and world.

2. TR6 lab is receiving the " Thyroglobulin Mass Spectrometry" technology from the National Cancer Institute (NCI) CLIA laboratory as a docking unit for pioneering cancer protein markers.

3. We participated in the five-year project of the Population-Based Cancer Research-Emerging Cancer Screening Study: Screening for High-risk Groups of Non-Smoking Lung Cancer in Taiwan by Low-Dose Computer Tomography since 2014. We found risk factors of Taiwan's lung cancer are significantly different to European and American though this study.

4. Join MOE ICP for NAPPA technology transfer from the University of Arizona (ASU). Hoping for establish a new biotechnology industry chain in Taiwan.

Using genetic test as a companion diagnosis has become the standard process for the treatment of many diseases. The TR6 laboratory is committed to the 3H development of "High accuracy, High added value and High demands" genetic testing. With the support of the Ministry of Science and Technology, TR6 will continue to contribute to the health of the Taiwanese people and the Taiwan biotechnology industry.

Media Contact

Yu, Sung-Liang

Clinical laboratory sciences and Medical Biotechnology, Natl. Taiwan University

slyu@ntu.edu.tw

+886-2-2312-3456 ext 88698 (Lab)

+886-2-2312-3456 ext 88697 (Office)

Jung-Tsun Chien

Postdoc

Department of Life Sciences, MOST

+886-2737-7990

jtchien@nstc.gov.tw