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Molecular Diagnostics:An Insight to Rising Markets and Trends in Cancer and Prenatal Technologies
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Molecular Diagnostics:An Insight to Rising Markets and Trends in Cancer and Prenatal Technologies
Published in December 2014 by Cambridge Healthtech Institute
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Insight Pharma Reports is a division of Cambridge Healthtech Institute, a world leader in life science information and analysis through conferences, research reports, and targeted publications. Insight Pharma Reports focus on pharmaceutical R&D – the technologies, the companies, the markets, and the strategic business impacts. They regularly feature interviews with key opinion leaders; surveys of the activities, views, and plans of individuals in industry and nonprofit research; and substantive assessments of technologies and markets. Managers at the top 50 pharma companies, the top 100 biopharma companies, and the top 50 vendors of tools and services rely on Insight Pharma Reports as a trusted source of balanced and timely information.
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Molecular Diagnostics:An Insight to Rising Markets and Trends in Cancer and Prenatal Technologies
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Executive Summary Molecular Diagnostics: An Insight to Rising Markets and Trends in Cancer and Prenatal Technologies
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M olecular Diagnostics: An Insight to Rising Markets and Trends in Cancer and Prenatal Technologies covers market research, relevant disease background, and a number of rising technologies available to physicians and clinicians.
This report has been divided into five parts. The first part of this report will focus on market growth and molecular diagnostic interest (Chapter 2). This chapter will discuss a brief overview of the growth of molecular diagnostics in several areas of cancer as well as prenatal diagnostics. These areas will be further discussed in later sections.
Part II focuses on cancer diagnostics, covering lung, breast, thyroid and blood cancers. These sections will include background information on all four types of cancers including risk, incidence, symptoms, early detection, and even targets under investigation. Information on a variety of companies working in the related cancer spaces and exclusive interviews with CEOs, Presidents, and Founders are also included. The companies that are featured include GeneCentric, which has two platforms available for breast and lung cancer; Veracyte, which has a platform for screening thyroid nodules found indeterminate by flow cytometry; and Adaptive Biotechnologies, which has a platform specifically for monitoring minimal residual disease (MRD) in blood cancers. Although these companies focus on different cancer-types, it is interesting to see the approach they are taking to meet market needs and tackle various diseases.
Part III of the report will focus on the prenatal aspect, covering background information and the growth of prenatal diagnostics. There are a variety of growing technologies and companies in this space. As far as genetic information is concerned, GenePeeks has a platform used for creating hypothetical genomes. This technology creates a portfolio of genomic combinations for clients and potential donors, screening for a number of genetic defects that could be present in these hypothetical children.
Also included in this section is information on sequence-based cell-free DNA testing and fetal cell isolation. These are two noninvasive strategies currently on the rise to alleviate the need for invasive testing (either amniocentesis or chorionic villus sampling). A company featured in this section is Verinata, which uses sequence-based cell-free DNA testing, a screening method that is currently recommended by the American College of Obstetricians and Gynecologists (ACOG).
The fourth part of this report will focus on survey results. Illustrated with several charts and graphs, this section will cover a number of techniques in development and challenges faced by the research and development community.
Finally, the fifth and final part is a complimentary company directory, featuring companies that are both mentioned and not mentioned in this report. This section gives insight to product development, clinical status, challenges, and competitive advantages.
Executive Summary
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Table of Contents Molecular Diagnostics: A Dynamic and Rapidly Broadening Market
Table of ContentsExecutive Summary vi
PART I:
Introduction and Market Background 1
CHAPTER 1
The Focus of This Report 2
CHAPTER 2:
Market Trends and Adaptability 3Lung cancer diagnostics market growth 4Breast cancer diagnostics market growth 5Thyroid cancer diagnostics market growth 6Blood cancer diagnostics market growth 7Prenatal diagnostics market growth 8
PART II:
Cancer Diagnostics 9
CHAPTER 3:
Lung Cancer 10Types of lung cancer 10Risk factors 10Incidence 11Symptoms and early detection 11Targeted therapies 12
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Table of Contents Molecular Diagnostics: A Dynamic and Rapidly Broadening Market
CHAPTER 4:
Breast Cancer 14Types of breast cancer 14Risk factors 14Incidence 15Symptoms and early detection 15Treatments for breast cancer 16
CHAPTER 5:
GeneCentric 18Company background 18Lung Subtype Platform (LSPTM) 18Hypoxia Signature Platform 19GeneCentric outlook 21Interview with Myla Lai-Goldman 22 Company background 22 Platforms 22 Lung Subtype Platform (LSPTM): 22 Hypoxia Signature platform: 23 Future outlook 23
CHAPTER 6:
Thyroid Cancer 24Types 24Risk 27Symptoms and early detection 27Therapeutic options 27
CHAPTER 7:
Veracyte 28
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Table of Contents Molecular Diagnostics: A Dynamic and Rapidly Broadening Market
Company background 28Afirma Thyroid FNA Analysis 28Validation 29Competitive advantage 29Future growth plans 30Interview with Bonnie Anderson 32 Company background 32 Afirma Thyroid FNA Analysis 32 Competitive advantage 34 Challenges encountered 35 Future improvements 35
CHAPTER 8:
Blood-Based Cancers 37Leukemia 37 Types 37 Risk factors, symptoms and early detection 38 Therapeutic options 38Lymphoma 38 Types 38 Classic Hodgkin disease 39
Nodular lymphocyte predominant Hodgkin disease 40 Non-Hodgkin lymphoma 40Risk factors 41Symptoms and therapeutic options 41
CHAPTER 9:
Adaptive Biotechnologies Corporation 42Company background 42ClonoSEQ 42
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Table of Contents Molecular Diagnostics: A Dynamic and Rapidly Broadening Market
Validation 43Areas of improvement 44Competitive advantage 44Future endeavors 44Interview with Chad Robins 46 Company background 46 ClonoSEQ 46 Areas of improvement 48 Challenges encountered 48 Competitive advantage 48 Future endeavors 49
PART III:
Genetic Information and Prenatal Diagnostics 50
CHAPTER 10:
Genetic Information and Prenatal Testing 51Genetic information 51Prenatal testing 51 Sequence-based cell-free DNA testing 51 Fetal cell isolation 52
CHAPTER 11:
GenePeeks 53Company background 53Patented technology 53How does the process work? 53Validation 54Accuracy and sensitivity 54Areas of improvement 54
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Table of Contents Molecular Diagnostics: A Dynamic and Rapidly Broadening Market
Competitive advantage 55Future applications 55Interview with Anne Morriss 57 Company background 57 Patented technology 57 Competitive advantage 59 Areas of improvement and future outlook 59
CHAPTER 12:
Verinata 61Company background 61The verifi® prenatal test 61Clinical validation and reimbursement 64Customer feedback 64
CHAPTER 13:
Testing Specifications 66
PART IV:
Survey Demographics 71
CHAPTER 14:
Survey Results 72Survey demographics 72Areas of study 73Rising technologies 74Challenges encountered 76
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Table of Contents Molecular Diagnostics: A Dynamic and Rapidly Broadening Market
PART V:
Company Directory 77
References 98
About Cambridge Healthtech Institute 103
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Table of Contents Molecular Diagnostics: A Dynamic and Rapidly Broadening Market
FIGURES
Figure 2.1: Growth in molecular diagnostics 3Figure 2.2: Growth in lung cancer diagnostics 4Figure 2.3: Growth in breast cancer diagnostics 5Figure 2.4: Growth in thyroid cancer diagnostics 6Figure 2.5: Growth in blood cancer diagnostics 7Figure 2.6: Growth in prenatal diagnostics 8Figure 3.1: Lung cancer deaths in men and women in the US 11Figure 4.1: Breast cancer deaths in women in the US 15Figure 14.1: Number of researchers working in molecular diagnostics 72Figure 14.2: Survey demographics 73Figure 14.3: Areas of study 73Figure 14.4: Specific area of diagnostics 74Figure 14.5: Technology status 74Figure 14.6: Type of technologies in development 75Figure 14.7: Technology basis 75Figure 14.8: Targets of interest 76Figure 14.9: Challenges encountered 76Figure 15.1: Rank of Clients Purchasing Technologies from Selected Vendors 97
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Table of Contents Molecular Diagnostics: A Dynamic and Rapidly Broadening Market
TABLES
Table 3.1: Targets and their clinical status 12Table 4.1: Targeted therapies for breast cancer 16Table 5.1: Lung Subtype Platform and Hypoxia Signature Platform 20Table 6.1: Thyroid cancer stages 25Table 7.1: Afirma Thyroid FNA Analysis Platform 31Table 8.1: Classic Hodgkin disease types and characteristics 39Table 8.2: B-cell and T-cell non-Hodgkin lymphomas 40Table 9.1: clonoSEQ platform specifications 45Table 11.1: Virtual Genome Platform 56Table 12.1: verifi® prenatal test performance for aneuploidies 63Table 12.2: verifi® prenatal test performance for sex chromosomes 63Table 12.3: verifi® prenatal test 65
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Part I: Introduction and Market Background Molecular Diagnostics: An Insight to Rising Markets and Trends in Cancer and Prenatal Technologies
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PART I:
Introduction and Market Background
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The Focus of This Report Molecular Diagnostics: An Insight to Rising Markets and Trends in Cancer and Prenatal Technologies
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CHAPTER 1
The Focus of This Report
T he focus of this report is to show the growth of molecular diagnostic technologies in two areas: cancer and prenatal research. The first part of the report covers market background and interest in several areas of cancer including lung, breast,
thyroid, and blood cancers (leukemia and lymphoma), as well as prenatal diagnostics. These areas are expanded upon in the following chapters.
Cancer is one of the leading causes of death, and therefore a popular area of study for screening and diagnostic assays. Within these chapters a number of factors are covered, including incidence, risk factors, symptoms, early detection and therapeutic options. Several companies have participated in these sections, including GeneCentric, Veracyte, and Adaptive Biotechnologies. Each company representative gives insight into their technologies in development, competitive advantage, and validation techniques. Also included in these chapters are interviews with company representatives conducted specifically for this report.
Another area of focus is in genetic information and prenatal diagnostics. Speaking to genetic information, one of the methods on the rise is predicting hypothetical fetal genomes for couples looking to conceive. Specifically highlighted in this space is GenePeeks. Historically, their technology has been used to match clients with optimal sperm
donors to reduce the risk of rare, recessive diseases, but now GenePeeks has been developing that technology for couples looking to conceive. And exclusive interview with this company is available as well.
Prenatal diagnostics is another area discussed, particularly the rise of noninvasive assays. A company highlighted in this section is Verinata Health, which uses sequence-based cell-free DNA testing to screen for chromosomal aneuploidies. By developing noninvasive technologies, clinicians and physicians can use less harmful invasive procedures (such as chorionic villus sampling and amniocentesis) to screen for these disorders, reducing the risk of miscarriage.
Also included is survey data that was pulled from the various companies and researchers working in molecular diagnostics. This section covers specific areas of focus that are actively being worked on as well as competitive strategies and challenges encountered.
Finally, the last part of the report is a company directory specifically created for this report. This section details over 10 companies, their areas of focus, and the status of their technologies.
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Market Trends and Adaptability Molecular Diagnostics: An Insight to Rising Markets and Trends in Cancer and Prenatal Technologies
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CHAPTER 2:
Market Trends and Adaptability
M olecular diagnostics has been an increasingly growing industry since the mid ‘90s. This is depicted in Figure 2.1. Over the last few years, a handful of companies have been on the rise and particularly in several areas including lung,
breast, thyroid and blood (leukemia and lymphoma) cancers as well as pre-conception genetic information and prenatal diagnostics. This section will show the growth of interest (based on PubMed articles) in the subjects that will be covered in this report.
Figure 2.1: Growth in molecular diagnosticsFigure 2.1: Growth of Molecular Diagnostics
Source: PubMed Search. Search limitations: (((molecular diagnostic[Title/Abstract]) OR diagnostic assay[Title/Abstract]) OR diagnostics[Title/Abstract]) OR assays[Title/Abstract]Article types: Clinical Trial, Clinical Trial, Phase I, Clinical Trial, Phase II, Clinical Trial, Phase III, Clinical Trial, Phase IV, Randomized Controlled Trial, Review, Systematic Reviews
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