伴隨診斷及個(gè)性化治療市場研究報(bào)告-中英.ppt

1、-勤勉務(wù)實(shí) -經(jīng)驗(yàn)豐富 -技術(shù)領(lǐng)先 - Assiduity and Practice Rich Experiences Leading Technologies 伴隨診斷及個(gè)性化治療市場研究報(bào)告 Market Research Report on Companion Diagnostics and Individual Treatment Client:Centre Testing International（ShenZhen）Corporation Prepared By :Luo yucheng Finish time：2012.04.18,2,目 錄 Contents,1、執(zhí)行摘要 2、

2、伴隨診斷介紹 3、世界伴隨診斷市場（2010年2021年） 4、伴隨診斷的主要市場（2010年2021年） 5、伴隨診斷市場中的產(chǎn)品：上市產(chǎn)品與研發(fā)產(chǎn)品（2011年） 6、伴隨診斷市場前景：公司與合伙人（2010年2011年） 7、伴隨診斷市場的四點(diǎn)（優(yōu)勢、劣勢、機(jī)會(huì)、威脅）分析 8、專家意見 9、結(jié)論,Executive Summary Introduction to Companion Diagnostics The World Companion Diagnostics Market, 2010-2021 Leading National Markets for Companion Di

3、agnostics, 2010-2021 Products in the Companion Diagnostics Market: Marketed and Pipeline, 2011 Companion Diagnostics Market Landscape: Companies and Partnerships, 2010-2011 SWOT Analysis of the Companion Diagnostics Market Expert Opinion Conclusions,3,1、執(zhí)行摘要 1、Executive Summary,1.1伴隨診斷市場回顧 1.2報(bào)告的目標(biāo)、

4、范圍與格式 1.2.1 章節(jié)大綱 1.3研究與分析方法,1.1Companion Diagnostics Market Review 1.2Aims, Scope and Format of the Report 1.2.1Chapter Outlines 1.3Research and Analysis Methods,4,2.1治療變化范例 2.2什么是個(gè)性化醫(yī)療？ 2.3體外診斷（IVD）與靶向治療：個(gè)性化醫(yī)療核心 2.3.1 什么是體外診斷（IVD）試驗(yàn)？ 2.3.2 體外診斷（IVD）如何幫助提供個(gè)性化治療 2.4伴隨診斷：個(gè)性化醫(yī)療工具 2.4.1 治療診斷科技：伴隨診斷的構(gòu)成部分

5、 2.5生物標(biāo)記物到伴隨診斷試劑 2.5.1 基因組類生物標(biāo)記物 2.5.2 癌癥中的基因組生物標(biāo)記物 2.6伴隨診斷的發(fā)展,2、伴隨診斷介紹 2、 Introduction to Companion Diagnostics,2.1Changing Paradigms of Treatment 2.2What is Personalised Medicine? 2.3In Vitro Diagnostics (IVD) and Targeted Therapies: The Core of Personalised Medicine 2.3.1What are In Vitro Diagnos

6、tic (IVD) Tests? 2.3.2How IVDs Help Provide Personalised Treatment 2.4Companion Diagnostics: Tools for Personalised Medicine 2.4.1Theranostics: A Subset of Companion Diagnostics 2.5Biomarkers to Companion Diagnostics 2.5.1Genomic Biomarkers 2.5.2Genomic Biomarkers in Oncology 2.6Development of Compa

7、nion Diagnostics,5,3.1范圍與限制 3.2伴隨診斷總體市場在2010年價(jià)值13億美元 3.3伴隨診斷總體市場（2010年2015年）的銷售及預(yù)測 3.4伴隨診斷總體市場（2016年2021年）的銷售預(yù)測 3.5伴隨診斷是體外診斷（IVD）市場發(fā)展最快的領(lǐng)域之一 3.5.1 伴隨診斷在體外診斷（IVD）市場獲得了較大的市場占有率 3.6治療診斷科技在2010年占伴隨診斷市場的31.5% 3.7治療診斷科技市場的強(qiáng)勁增長（2011年2021年） 3.7.1 治療診斷科技在伴隨診斷市場獲得了較大的市場占有率（2011年-2021年）,3、世界伴隨診斷市場（2010年2021年）

8、3、 The World Companion Diagnostics Market, 2010-2021,3.1Scope and Limitations 3.2Total Companion Diagnostics Market was Worth $1.30bn in 2010 3.3Sales Forecast for Total Companion Diagnostics Market, 2010-2015 3.4Sales Forecast for Total Companion Diagnostics Market, 2016-2021 3.5Companion Diagnosti

9、cs is One of the Fastest Growing Segments in the IVD Market 3.5.1Companion Diagnostics Gaining Greater Share of the IVD Market 3.6Theranostics Constituted 31.5% of the Companion Diagnostics Market in 2010 3.7Strong Growth in the Theranostics Market, 2011-2021 3.7.1Theranostics Gaining Greater Share

10、of the Companion Diagnostics Market, 2011-2021,6,4.1伴隨診斷的主要市場（2010年） 4.2伴隨診斷的主要市場：銷售預(yù)測（2011年2021年） 4.2.1 美國伴隨診斷市場（2011年2021年） 4.2.2 歐洲主要伴隨診斷市場（2011年2021年） 4.2.3 日本伴隨診斷市場（2011年2021年） 4.2.4 新興經(jīng)濟(jì)體體伴隨診斷市場 4.2.4.1中國伴隨診斷市場（2011年2021年） 4.2.4.2印度伴隨診斷市場（2011年2021年）,4、 伴隨診斷的主要市場（2010年2021年） 4、 Leading Nationa

11、l Markets for Companion Diagnostics, 2010-2021,4.1Leading National Markets for Companion Diagnostics, 2010 4.2Leading National Markets for Companion Diagnostics: Sales Forecast, 2011-2021 4.2.1The US Companion Diagnostics Market, 2011-2021 4.2.2The Leading European Companion Diagnostics Markets, 201

12、1-2021 4.2.3The Japanese Companion Diagnostics Market, 2011-2021 4.2.4Emerging-Economy Companion Diagnostics Markets 4.2.4.1 The Chinese Companion Diagnostics Market, 2011-2021 4.2.4.2 The Indian Companion Diagnostics Market, 2011-2021,7,5.1伴隨診斷引入生物標(biāo)記 5.2伴隨診斷市場：規(guī)模小，但不斷增長 5.3多調(diào)控出路的復(fù)雜市場 5.4上市伴隨診斷產(chǎn)品 （2

13、011年） 5.5研發(fā)中的伴隨診斷產(chǎn)品 5.6腫瘤學(xué)是伴隨診斷發(fā)展的主要指標(biāo),5、 伴隨診斷市場中的產(chǎn)品：上市產(chǎn)品與研發(fā)產(chǎn)品（2011年） 5、 Products in the Companion Diagnostics Market: Marketed and Pipeline, 2011,5.1Biomarkers Being Developed into Companion Diagnostics 5.2Market for Companion Diagnostics: Small, but Growing 5.3A Complex Market with Multiple Regula

14、tory Pathways 5.4Marketed Theranostics, 2011 5.5Pipeline Companion Diagnostics 5.6Oncology is the Leading Indication for the Development of Companion Diagnostics,8,6.1概述 6.2伴隨診斷市場中的利益相關(guān)者 6.2.1 管理機(jī)構(gòu)促進(jìn)了伴隨診斷的發(fā)展 6.2.2 試驗(yàn)實(shí)驗(yàn)室 6.2.3 內(nèi)科醫(yī)生與患者：需要掌握更多知 識以推動(dòng)做出治療決策 6.2.4 治療診斷科技產(chǎn)品市場為制藥和診 斷公司創(chuàng)造了機(jī)會(huì) 6.3使用伴隨診斷的利益：制藥和

15、診斷公 司的前景 6.4伴隨診斷市場中的公司 6.4.1 推動(dòng)公司進(jìn)入伴隨診斷市場的因素 6.4.2 伴隨診斷市場中的公司：開發(fā)產(chǎn)品， 提供服務(wù) 6.5伴隨診斷開發(fā)的商業(yè)模式 6.5.1 少數(shù)制藥公司擁有專用診斷設(shè)備 6.5.2 與制藥廠協(xié)調(diào)：診斷公司雙贏 6.5.3 瑞士羅氏制藥公司：伴隨診斷一站 式服務(wù)點(diǎn) 6.5.4 凱杰公司：合伙模式發(fā)展 6.6伴隨診斷發(fā)展經(jīng)營（2010年2011年）,6、伴隨診斷市場前景：公司與合伙人（2010年2011年） 6、Companion Diagnostics Market Landscape: Companies and Partnerships, 20

16、10-2011,6.1Overview 6.2Stakeholders in the Companion Diagnostics Market 6.2.1Regulatory Authorities Promoting the Development of Companion Diagnostics 6.2.2Testing Laboratories 6.2.3Physicians and Patients: Need to be More Informed to Drive Treatment Decisions 6.2.4The Market for Theranostic Product

17、s is Creating Opportunities for Pharmaceutical and Diagnostic Companies 6.3Benefits of Employing Companion Diagnostics: Perspective of Pharmaceutical and Diagnostic Companies 6.4Companies in the Companion Diagnostics Market 6.4.1Factors Driving Companies to Enter the Companion Diagnostics Market 6.4

18、.2Companies in the Companion Diagnostics Market: Developing Products and Providing Services 6.5Business Models for the Development of Companion Diagnostics 6.5.1Few Pharmaceutical Companies Have Dedicated Diagnostics Units 6.5.2Collaborating with Pharmaceuticals: A Win-Win for Diagnostic Companies 6

19、.5.3Roche: A One Stop Shop for Companion Diagnostics 6.5.4Qiagen: Growing on the Partnership Model 6.6Deals for Development of Companion Diagnostics, 2010-2011,9,7.1介紹 7.2伴隨診斷的優(yōu)勢與劣勢 7.2.1 最大化增加醫(yī)療保健利益相關(guān)者 的利益 7.2.2 最大化降低傷害 7.2.3 增加依從性 7.2.4 流線化臨床試驗(yàn) 7.2.5 恢復(fù)不合格或停用藥物 7.2.6 減少醫(yī)療保健成本 7.2.7 實(shí)現(xiàn)響應(yīng)到預(yù)防的轉(zhuǎn)變 7.2.

20、8 與藥物生產(chǎn)相比，診斷領(lǐng)域是傳 統(tǒng)不受重視的科學(xué)領(lǐng)域。 7.2.9 體會(huì)較低收入和較高銷售成本 7.3機(jī)會(huì)與威脅 7.3.1 生物標(biāo)記：轉(zhuǎn)換為伴隨診斷 7.3.2 賠償挑戰(zhàn) 7.3.3 缺乏伴隨診斷相關(guān)的明確監(jiān)管指 南 7.3.4 復(fù)雜商業(yè)模式：矛盾的目標(biāo) 7.3.5 對制藥公司主打藥品模式的威脅,7、伴隨診斷市場的SWOT（優(yōu)勢、劣勢、機(jī)會(huì)、威脅）分析 7、SWOT Analysis of the Companion Diagnostics Market,7.1 Introduction 7.2 Strengths and Weaknesses of the Sector 7.2.1 Ma

21、ximising Benefits to Healthcare Stakeholders 7.2.2 Minimising Harm 7.2.3 Increasing Compliance 7.2.4 Streamlining Clinical Trials 7.2.5 Reviving Failed or Withdrawn Drugs 7.2.6 Reducing the Costs of Healthcare 7.2.7 Shifting From Reaction to Prevention 7.2.8 The Field of Diagnostics Has Traditionall

22、y Been an Undervalued Area of Science When Compared to the Production of Pharmaceuticals 7.2.9 Perceived Lower Revenues and Higher Marketing Costs 7.3 Opportunities and Threats 7.3.1 Biomarkers: Translating into Companion Diagnostics 7.3.2 Reimbursement Challenges 7.3.3 Lack of Clear Regulatory Guid

23、elines on Companion Diagnostics 7.3.4 Complex Business Models: Contradicting Objectives 7.3.5 Threat to the Blockbuster Model of Pharmaceutical Companies,10,8.1來自該領(lǐng)域診斷公司主管（觀點(diǎn)匿名提供） 8.1.1體外診斷（IVD）最有前景的治療領(lǐng)域 8.1.2體外診斷（IVD）無法滿足的治療需求 8.1.3市場發(fā)展的最大障礙 8.1.4發(fā)展中國家體外診斷（IVD）市場發(fā)展前景 8.1.5治療診斷的前景 8.2訪問Herbie Newell

24、（英國紐卡斯?fàn)柎髮W(xué)北方癌癥 研究院教授） 8.2.1癌癥治療生物標(biāo)記的重要性 8.2.2新生物標(biāo)記發(fā)現(xiàn)過程中使用的科技平臺 8.2.3將癌癥生物標(biāo)記發(fā)現(xiàn)轉(zhuǎn)換到臨床的挑戰(zhàn) 8.2.4癌癥異質(zhì)性與靶向治療 8.2.5制藥研究與發(fā)展革新與公私合作關(guān)系的重要性 8.2.6癌癥研究的當(dāng)前趨勢與未來 8.3全球制藥公司診斷部副總裁（觀點(diǎn)匿名提供） 8.3.1伴隨診斷的定義 8.3.2制藥公司與伴隨診斷市場 8.3.3伴隨診斷市場的推動(dòng)力與限制 8.3.4伴隨診斷試驗(yàn)發(fā)展最有前景的治療領(lǐng)域 8.3.5伴隨診斷市場和未來發(fā)展的最近趨勢 8.4 國內(nèi)專家總結(jié),8、 專家意見 8、 Expert Opinion,

25、8.1 Director from a Diagnostics Company in the Sector (Views Provided Anonymously) 8.1.1 Most-Promising Therapeutic Areas for IVD 8.1.2 Unmet Medical Needs in IVD 8.1.3 Greatest Obstacles to Market Growth 8.1.4 Prospects for IVD Market Growth in Developing Countries 8.1.5 Prospects for Theranostics

26、8.2 Interview with Herbie Newell, Professor of Cancer Therapeutics, Northern Institute for Cancer Research, University of Newcastle, UK 8.2.1 The Importance of Biomarkers for Cancer Therapy 8.2.2 Technological Platforms Used in the Discovery of Novel Biomarkers 8.2.3 The Challenges of Translating Ca

27、ncer Biomarker Discoveries to the Clinic 8.2.4 Cancer Heterogeneity and Targeted Therapy 8.2.5 Reform in Pharmaceutical R on the same day an in vitro diagnostic test to determine which patients would benefit was approved by the FDA. The drug and diagnostic device work together in tandem. The treatme

28、nt approach has always been personalised in the sense that IVDs available in the market allow the diagnosis and confirmation of a disease, which can then be treated with appropriate drugs. Unlike a complete hit-and-trial method, diagnostic tests allow to confirm if a patient is infected with a parti

29、cular disease, such as tuberculosis or any form of hepatitis. The use of IVDs has been moving the therapy towards a more personalised approach, where a sub-population of patients can be identified to benefit from use of a particular drug. Such diagnostic tests that are linked to a particular drug ar

30、e known as companion diagnostics, and the corresponding drugs as companion drugs.,46,伴隨診斷是體外診斷（IVD）試驗(yàn)，旨在幫助健康專家為患者制定正確的治療決策。治療診斷/基因藥理學(xué)也是常使用的伴隨診斷術(shù)語。這兩個(gè)術(shù)語通?？山粨Q使用。但是，伴隨診斷和治療診斷之間是有區(qū)別的，下文中將進(jìn)行說明。 當(dāng)與藥物結(jié)合使用時(shí)，這些試驗(yàn)的使用可幫助內(nèi)科醫(yī)生評估特殊藥物在患者群或子群中的功效和安全性。因此，伴隨診斷包括能夠影響藥物處方的診斷試驗(yàn)。市場上可用的伴隨診斷可根據(jù)其目的/用途分為下列種類（圖2.2）： 敏感試驗(yàn)是確定從基

31、因方面易于產(chǎn)生特定疾病的患者，推薦使用預(yù)防藥物 監(jiān)查試驗(yàn)是根據(jù)藥物不良反應(yīng)的發(fā)展風(fēng)險(xiǎn)，測定患者對特定藥物/劑量選擇的敏感性。 選擇試驗(yàn)是確定使用特定藥物可取得療效的患者分組人口。 從過去幾年顯示來看，一定數(shù)量的特定疾病跡象用藥物只對某個(gè)患者群體有效?；颊邔τ谒幬锏姆磻?yīng)可通過單核苷酸多態(tài)性（SNP）的存在與否控制。從本質(zhì)上來講，伴隨診斷試驗(yàn)提供了關(guān)于患者基因和基因組特性的信息，例如是否存在可影響藥物處方的生物標(biāo)記。,2、伴隨診斷介紹（4）伴隨診斷：個(gè)性化醫(yī)療工具 2、Introduction to Companion Diagnostics-（4） Companion Diagnostics:

32、Tools for Personalised Medicine,Companion diagnostics are IVD tests that are intended to assist health professionals make the right treatment decisions for patients. Theranostics/pharmacodiagnostics are other commonly used terms for companion diagnostics. The two terms are often used interchangeably

33、. However, there is a difference between companion diagnostics and theranostics, which we will describe below. The use of these tests when combined with a drug assists the physicians to evaluate the efficacy and safety of a specific drug in a group or sub-group of patients. Thus, companion diagnosti

34、cs includes diagnostic tests that have the ability to influence drug prescription. The companion diagnostics available in the market can be classified into the following categories depending on their purpose/use (Figure 2.2): Susceptibility tests to identify patients who are genetically prone to dev

35、eloping a particular disease, recommending the use of preventive drugs Monitoring tests to measure patients sensitivity to a particular drug/dosage selection depending on risk of development of adverse drug reaction Selection tests to identify patient sub-populations who would benefit from a particu

36、lar drug. A number of drugs for a particular disease indication are effective in only a sub-population of patients, as has been revealed in the past few years. A patients response to a drug can be governed by presence or absence of a SNP. Essentially, companion diagnostic tests provide information o

37、n a patients genetic and genomic characteristics, such as presence of absence of a biomarker, which can influence drug prescription.,47,2、伴隨診斷介紹（4）伴隨診斷：個(gè)性化醫(yī)療工具 2、Introduction to Companion Diagnostics-（4） Companion Diagnostics: Tools for Personalised Medicine,48,2.4.1治療診斷：伴隨診斷工具 在專用術(shù)語中，治療診斷可定義為與特定藥物密

38、切相關(guān)的伴隨診斷。從本質(zhì)上來講，治療診斷是主要在處方相應(yīng)藥物前使用的診斷試驗(yàn)。美國和歐洲藥物管理機(jī)構(gòu)美國食品與藥物管理局（FDA）和歐洲藥品管理局（EMA）要求在決定使用某種伴隨藥物前進(jìn)行一些生物標(biāo)記試驗(yàn)。這些藥物診斷組合被定義為治療診斷。但是，由于治療診斷市場是新市場，還沒有明確定義，治療診斷通常代替伴隨診斷使用。在該市場中，隨著市場的成熟，將繼續(xù)得以完善。一些目前可用的治療診斷范例見表5.3。,2、伴隨診斷介紹（4）伴隨診斷：個(gè)性化醫(yī)療工具 2、Introduction to Companion Diagnostics-（4） Companion Diagnostics: Tools fo

39、r Personalised Medicine,2.4.1 Theranostics: A Subset of Companion Diagnostics In specific terms, theranostics can be defined as the companion diagnostics that are intimately tied to a specific drug. Essentially, theranostics are diagnostics tests, the use of which is essential before the correspondi

40、ng drug is prescribed. The US and European drug regulatory authorities FDA and EMA require the testing of some biomarkers prior to deciding on the use of a companion drug. Such drug- diagnostic combinations are defined as theranostics. However, theranostics is commonly used in place of companion dia

41、gnostics, as this market is new and not yet well defined. In this niche market, the definitions will continue to be refined as the market matures. Examples of some currently available theranostics are presented in Table 5.3.,49,總的來說，生物標(biāo)記可以被定義為一種功用化學(xué)物質(zhì)，充當(dāng)生物狀態(tài)的指示器。在醫(yī)療中，生物標(biāo)記可以被定義為有機(jī)體中引入的可追蹤物質(zhì)，以便檢驗(yàn)器官功能。

42、例如，銣-82氯化物在市場上的商標(biāo)名稱是Cardiogen-82，用于成像心臟肌肉活動(dòng)性。這是由于該物質(zhì)可被心臟快速接納，可用于確定缺乏血流的心臟區(qū)域。生物標(biāo)記也可以使?jié)舛扰c疾病發(fā)展相關(guān)的物質(zhì)。 如果所提的生物標(biāo)記通過實(shí)驗(yàn)驗(yàn)證，則可用于診斷個(gè)體發(fā)生疾病的風(fēng)險(xiǎn)或是否患病。近年來，制藥公司對在其策略藥物開發(fā)計(jì)劃中加入生物標(biāo)記越來越感興趣。生物標(biāo)記已經(jīng)成功開發(fā)到靶向治療伴隨診斷試驗(yàn)中。如圖2.3所示，任何生物標(biāo)記類型預(yù)兆、預(yù)測性或藥效性都能且已經(jīng)開發(fā)到伴隨診斷中。,2、伴隨診斷介紹（5）伴隨診斷生物標(biāo)記 2、Introduction to Companion Diagnostics-（5） Biom

43、arkers to Companion Diagnostics,Broadly speaking, a biomarker can be defined as a chemical substance with the utility to act as an indicator of a biological state. In medicine, a biomarker can be defined as a traceable substance introduced into an organism in order to examine organ function. For exa

44、mple, rubidium-82 chloride is marketed under the brand name Cardiogen-82 and is used to image heart muscle activity. This is because the substance is rapidly taken up by the heart and can be used to identify regions of the heart that are receiving poor blood flow. A biomarker can also be a substance

45、 whose concentration can be correlated with the progression of a disease. If a proposed biomarker is experimentally validated it can be used to diagnose the risk or presence of disease in an individual. In recent years pharmaceutical companies have become increasingly interested in incorporating bio

46、markers within their strategic drug development plans. Biomarkers have been successfully developed into companion diagnostic tests for targeted therapies. As shown in Figure 2.3, any of the various types of biomarkers prognostic, predictive, or pharmacodynamic can and have been developed into compan

47、ion diagnostics.,50,2、伴隨診斷介紹（5）伴隨診斷生物標(biāo)記 2、Introduction to Companion Diagnostics-（5） Biomarkers to Companion Diagnostics,51,2.5.1基因組生物標(biāo)記 基因組學(xué)是涉及有機(jī)體基因組研究的生物學(xué)領(lǐng)域?；蚪M測序是確定有機(jī)體DNA序列的實(shí)驗(yàn)過程。詳細(xì)了解單個(gè)基因組后，研究人員能夠?qū)颊哌M(jìn)行比較。通過對比健康和疾病基因組，我們能夠了解與特定疾病相關(guān)的基因組部分。因此，基因組學(xué)是辨別個(gè)體患病風(fēng)險(xiǎn)的強(qiáng)有力方式。當(dāng)遇到最嚴(yán)重的疾?。ɡ绨┌Y）時(shí)，基因組在了解和管理疾病方面發(fā)揮重大作用，這是

48、因?yàn)榛蚪M： 影響癌癥的生物學(xué)敏感性和感染 提供將腫瘤劃分為預(yù)兆子類型的方法 使醫(yī)生能夠根據(jù)惡性組織突變預(yù)測疾病惡化。 但是，當(dāng)與常規(guī)實(shí)驗(yàn)室試驗(yàn)進(jìn)行對比時(shí)，基因組生物標(biāo)記在具體應(yīng)用時(shí)遇到了困難。包括眾多分析、生物信息學(xué)和生物倫理學(xué)問題。目前，基因組測序科技仍然花費(fèi)太高（盡管沒有十年前花費(fèi)那么高了），無法常規(guī)用于疾病的臨床診斷。,2、伴隨診斷介紹（5）伴隨診斷生物標(biāo)記 2、Introduction to Companion Diagnostics-（5） Biomarkers to Companion Diagnostics,2.5.1 Genomic Biomarkers Genomics i

49、s the field of biology that is concerned with the study of the genomes of organisms. Genomic sequencing is an experimental process that determines the DNA sequence of an organism. The detailed understanding of an individual genome allows researchers to compare patients. By comparing the genomes of t

50、he healthy and the ill, we can understand which parts of the genome are associated with certain diseases. Thus genomics is a powerful way of discerning the risk of individuals towards disease. When it comes to the most serious diseases (such as cancer), the genome has an important role to play in th

51、e understanding and management of disease because the genome: Influences the biological susceptibility and contraction of cancer Provides the means to stratify tumours into prognostic subtypes Allows doctors to predict disease progression based on the mutations in the malignant tissue. However, when

52、 compared with conventional laboratory tests, the use of genomic biomarkers present specific implementation challenges. These include a host of analytical, bioinformatics and bioethical issues. At present, genomic sequencing technologies remain too expensive (although not as expensive as a decade ag

53、o) to be routinely used for the clinical diagnoses of disease.,52,2.5.2腫瘤學(xué)的基因組生物標(biāo)記 癌癥使用的第一個(gè)預(yù)測性生物標(biāo)記在三十多年前就已經(jīng)公開了。試驗(yàn)是根據(jù)雌性激素受體試驗(yàn)，選擇患有乳腺癌的個(gè)體，目的是對這些患者進(jìn)行抗激素治療、三苯氧胺治療。1998年，赫賽汀稱為乳腺癌第二靶向治療。隨后開發(fā)了量化乳腺腫瘤中的人類表皮生長因子受體2（HER2）水平的伴隨診斷試驗(yàn)。還開發(fā)了藥物靶向表皮生長因子受體（EGFR），包括抑制劑吉非替尼和埃羅替尼。臨床可用的腫瘤學(xué)生物標(biāo)記清單可見表2.2。近年來，在腫瘤學(xué)生物標(biāo)記領(lǐng)域出現(xiàn)了大量研究

54、活動(dòng)。DNA測序在研究活動(dòng)中發(fā)揮了關(guān)鍵作用。除了生物標(biāo)記發(fā)現(xiàn)外，我們還能通過癌癥基因組測序找到新的藥物靶標(biāo)。,2、伴隨診斷介紹（5）伴隨診斷生物標(biāo)記 2、Introduction to Companion Diagnostics-（5） Biomarkers to Companion Diagnostics,2.5.2 Genomic Biomarkers in Oncology The first predictive biomarker used for cancer was unveiled more than three decades ago. The test was based

55、on estrogen-receptor testing to select individuals with breast cancer for the purposes of treating them with the anti-hormonal therapy, tamoxifen. In 1998, trastuzumab became the second targeted therapy for breast cancer. Companion diagnostic tests that quantify levels of HER2 in breast tumours were

56、 subsequently developed. Drugs targeting EGFR have also been developed and these include the inhibitors gefitinib and erlotinib. A list of clinically useful oncology biomarkers can be found in Table 2.2. In recent years, there has been a great deal of research activity in the field of oncology bioma

57、rkers. DNA sequencing has played a key role in this effort. In addition to biomarker discovery, cancer genome sequencing allows us to search for new drug targets.,53,2、伴隨診斷介紹（5）伴隨診斷生物標(biāo)記 2、Introduction to Companion Diagnostics-（5） Biomarkers to Companion Diagnostics,Source: Visiongain,54,一般來說，有兩組伴隨診斷

58、，分別是： 共同開發(fā)的伴隨診斷 售后伴隨診斷 共同開發(fā)試驗(yàn)是與藥物互相協(xié)調(diào)開發(fā)的（例如作為伴隨）。在這種情況中，伴隨診斷與研究藥物同時(shí)開發(fā)。在藥物臨床研究過程中，識別、確認(rèn)并使用生物標(biāo)記。在這些情況中，診斷可與伴隨藥物同時(shí)得到批準(zhǔn)。這些伴隨診斷通常被批準(zhǔn)為組合產(chǎn)品，但不一定都是這種情況。美國食品與藥物管理局（FDA）建議伴隨診斷藥物組合開發(fā)商與體外診斷器械評價(jià)與安全辦公室（OIVD）聯(lián)系并合作，以避免延誤診斷審查。赫塞汀、爾必得舒和維克替比是伴隨診斷試驗(yàn)與藥物同時(shí)獲得批準(zhǔn)的其中一些藥物。,2、伴隨診斷介紹（6）伴隨診斷的發(fā)展 2、Introduction to Companion Diagno

59、stics-（6） Development of Companion Diagnostics,Broadly speaking, there are two groups of companion diagnostics and these are: Co-developed companion diagnostics After-market companion diagnostics Co-developed tests are developed in conjunction (i.e. as a companion) to a drug. In such cases, the comp

60、anion diagnostics are simultaneously developed with an investigational drug. A biomarker is identified, validated and utilised in the drug clinical studies. In these cases, the diagnostic can be approved at the same time as the companion drug. Such companion diagnostic are usually approved as combin