Companion Diagnostics and Other Aspects of Personalized Medicine

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Jun 11, 2013, 11:54 ET

NEW YORK, June 11, 2013 /PRNewswire/ -- Reportlinker.com announces that a new market research report is available in its catalogue:

Companion Diagnostics and Other Aspects of Personalized Medicine
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The focus of this report is the use of personalized medicine for pharmacological/diagnostic combinations; particularly pharmacological therapies and the diagnostic tests, which can provide information on the likelihood of a patient to respond to specific treatments.

Historically, drugs have been developed on a "one-size-fits-all" basis, but due to patients responding differently to the same drug and having potentially life threatening side effects, new therapies have been developed for approaching the treatment of diseases. Such an approach is with personalized medicine.
Personalized medicine is an all-encompassing term for focused treatments in diseases. While in some areas, personalized medicine may focus on an inpidual's genome in response to therapy, in others it may be broader and focus on tailoring a medical treatment to the characteristics of each patient.
Often in the form of drug/diagnostic combinations, personalized medicine is commonly used in treating breast cancer. Such an example is using estrogen and progesterone receptors, which are biomarkers, in combination with immunochemistry tests to determine an appropriate therapy. Other methods of personalized medicine for breast cancer include testing for HER2/neu overexpression as well as testing for the presence of multiple genes. With drug/diagnostic combinations, physicians can identify patients who are likely to respond to specific treatments.

With personalized medicine becoming a more effective form of treatment, more diagnostic tests are being developed to use in combination with pharmacology. Using this form of treatment, physicians not only target the proper disease with the proper therapy, but patients are also less likely to develop adverse reactions and life threatening side effects.

Main concepts of personalized medicine covered in this report include:
• Various definitions of personalized medicine
• Range of disease applications for personalized medicine
• Use of personalized medicine in research and development
• Technologies used in personalized medicine testing
• Examples of drug/diagnostic combinations currently in use
• Examples of drug/diagnostic combinations in development
• Development of diagnostic and therapeutic products
• Extensive tables which include information on diagnostic companies that market personalized medicine in vitro diagnostic tests and/or services through their own CLIA laboratory
• Survey of 157 participants (including pharmaceutical/biopharmaceutical companies, diagnostic companies, CROs, universities or research institutes, clinical/reference/hospital laboratories, among others) with experience working with personalized medicine
• Interviews with pharmaceutical and diagnostic companies actively participating in personalized medicine

About the Author
Lucy J. Sannes, PhD, MBA, is president of Sannes & Associates, a consulting firm specializing in evaluation and management of the biosciences. Before forming Sannes & Associates, she held management positions at Genetic Systems and Abbott Laboratories in product development, product support, and technical marketing. Dr. Sannes received her PhD in biological chemistry from the University of Michigan and her MBA from Seattle Pacific University.

Table of Contents

Introduction
Executive Summary

Chapter 1 Introduction

Chapter 2 Overview of Personalized Medicine
2.1. What is Personalized Medicine?
2.2. Selected Terms Used in Personalized Medicine
• Pharmacogenomics
• Pharmacogenetics
• Companion Diagnostics
• Other Terms Used in Personalized Medicine
2.3. Disease Applications Where Personalized Medicine May Be Used
2.4. Diagnostic Technologies Used in Personalized Medicine

Chapter 3 Selected Examples of Personalized Medicine (Drug/Diagnostic Combinations and Prevention of Adverse Effects) in Use Today
3.1. Estrogen Receptor and Progesterone Receptor Status: Breast Cancer
3.2. HER2 Overexpression in Breast Cancer
3.3. Multigene Tests for Determining Breast Cancer Prognosis and Treatment
• Agendia's Symphony: MammaPrint, TargetPrint, BluePrint, TheraPrint
• bioTheranostics' Breast Cancer Index
• Clarient's Mammostrat Breast Cancer Test
• Genomic Health's Oncotype DX Breast Cancer Assay
3.4. Multigene Tests for Determining Diagnosis, Prognosis, and Treatment of Other Cancers
• Agendia's ColoPrint
• bioTheranostics' CancerTYPE ID
• Clarient's Genomics' Pulmotype Lung Cancer Test
• Genomic Health's Oncotype DX Colon Cancer Assay
• Pathwork Diagnostics' Pathwork Tissue of Origin Test
3.5. Epidermal Growth Factor Receptor (EGFR)
• Testing for Expression of EGFR
• Testing for EGFR Mutations
3.6. KRAS Mutations and Anti-EGFR Therapy for Colorectal Cancer
3.7. BRAF Mutations
• BRAF Mutations and Melanoma
• BRAF Mutations and Anti-EGFR Therapy for Colorectal Cancer
3.8. ALK Gene Rearrangements and Non–Small-Cell Lung Cancer
3.9. DPYD and TYMS Variants and 5-Flurouracil Therapy
3.10. Biomarkers in Hematological Cancers
• Gleevec and Other Tyrosine Kinase Inhibitors for Treatment of Philadelphia Chromosome-Positive CML
• Philadelphia Chromosome and Busulfan
• PML/RARalpha and Vesanoid (tretinoin)/Trisenox (arsenic trioxide)
• Rituxan and Other Antibodies That Target CD20 Antigen for Treatment of Lymphoma or Leukemia
• Many Additional Biomarkers for Leukemia and Lymphoma
• Biomarkers for Myelodysplastic Syndromes (MDS) and Myeloproliferative Diseases
3.11. Thiopurine Methyltransferase and Metabolism of Thiopurine Drugs
3.12. Cytochrome P450
• CYP2D6 Phenotype and Response to Tamoxifen
• CYP2C19 Phenotype and Plavix (clopidogrel bisulfate)
• Cytochrome P450 Enzymes and Other Drugs
3.13. UGT1A1 Genetic Variants and Treatment with Camptosar (irinotecan)
3.14. CYP2C9 and VKORC1 Variants and Warfarin Dosing
3.15. Personalized Medicine and HIV Therapy: Moving Beyond HIV Viral Load and Drug Resistance Testing
• HLA-B*5701 Testing and Hypersensitivity to Abacavir
• CCR5-Tropic HIV and Selzentry (maraviroc)
3.16. Selected CNS Applications of Personalized Medicine
3.17. Selected Other Personalized Medicine Tests

Chapter 4 Selected Examples of Emerging Drug/Diagnostic Combinations and Other Personalized Medicine Tests in Development
4.1. Personalized Medicine Tests in Development
• 20/20 GeneSystems
• Abbott Molecular
• BD
• Biocartis
• Biodesix
• bioMérieux
• Dako (An Agilent Technologies Company)
• Genomic Health
• Ignyta
• Insight Genetics
• Myriad Genetics
• Qiagen
• Roche (Including Roche Molecular Diagnostics and Ventana Medical Systems)
• Other Personalized Medicine Tests in Development
4.2. Next-Generation Sequencing and Personalized Medicine
4.3. Pharmaceutical/Diagnostic Company Agreements
4.4. Other Diagnostic Company Agreements in Personalized Medicine

Chapter 5 Development of Drug/Diagnostic Combinations: Personalized Medicine Products
5.1. Identification of Personalized Medicine Biomarkers
5.2. Validation of Biomarkers and Diagnostic Tests for Personalized Medicine
5.3. Development and Regulatory Issues Facing Diagnostic Companies in Personalized Medicine

• Regulatory Issues and Considerations for Diagnostic Companies with CLIA-Certified Laboratories and Clinical Laboratories with Laboratory-Developed
• Tests for Personalized Medicine
• Regulatory Issues and Considerations for Diagnostics Companies in Personalized Medicine
• The FDA Review Processes and Classifications for Diagnostic Tests

5.4. Development and Regulatory Issues Facing Therapeutic Companies in Personalized Medicine
5.5. Selected Personalized Medicine Examples: What Tests Are Used by Physicians?

• Why Isn't Warfarin Sensitivity Testing Routinely Performed?
• Screening for HLA-B*5701 Hypersensitivity to Abacavir
• Genomic Health and Validation of Oncotype DX Breast Cancer Assay

Chapter 6 Business Considerations for Pharmaceutical and Diagnostic Companies Developing Personalized Medicine Products
6.1. Need for More Research and Understanding
• Biomarkers and Other Factors Influencing Response to Therapy
• Validation Studies and Outcome Studies
• Other Research and Information Needs

6.2. Models/Options for Pharmaceutical Companies Developing Drug/Diagnostic Combinations
6.3. Models/Options for Diagnostic Companies Developing Personalized Medicine Tests
6.4. Delivery of New Diagnostic Tests: IVD vs. CLIA Laboratory
6.5. Health Economics, Reimbursement, and the Payers' Perspective
• Health Economic Studies for Personalized Medicine Tests
• Perspectives Expressed in Expert Interviews
• Payer Perspectives and Policies
• Companies Providing Services to Diagnostic Companies, Payers, and Providers in Personalized Medicine
• Changes in Reimbursement for Molecular Diagnostic Tests

6.6. Intellectual Property Issues
6.7. Penetrating the Market
• Does the Test Affect Physicians' Decisions?
• Does The Test Improve Patient Outcomes?
• Acceptance by Experts; Incorporation into Guidelines
• Education of Physicians, Other Health Professionals, and Other Stakeholders
• Current Barriers and Growing Use of Personalized Medicine Tests

Chapter 7 Company Perspectives on Personalized Medicine
7.1. Potential Benefits, Risks, and Challenges for Biopharmaceutical and Pharmaceutical Companies
7.2. Potential Benefits, Risks, and Challenges for Diagnostic Companies

Chapter 8 Results of Insight Pharma Reports' Personalized Medicine Survey

Chapter 9 Expert Interviews
9.1. Stephen Eck, MD, PhD, Vice President, Oncology, Astellas Global Pharma Development
9.2. Paul Beresford, PhD, Vice President, Business Development & Strategic Planning, Biodesix
9.3. Richard Ding, CEO, bioTheranostics (A bioMérieux Company)
9.4. Mark J. Ahn, PhD, President & Chief Executive Officer Rosemary Mazanet, MD, PhD, Executive Vice President & Chief Medical Officer, Galena Biopharma
9.5. Howard Coleman, Chairman and Chief Executive Officer, Genelex
9.6. Stephen Little, PhD, Vice President, Personalized Healthcare, Qiagen
9.7. Felix Frueh, PhD, Entrepreneur-in-Residence, Third Rock Ventures
9.8. Joshua P. Cohen, PhD, Senior Research Fellow, Tufts Center for the Study of Drug Development
9.9. Michael Laposata, MD, PhD, Edward and Nancy Fody Professor and Executive Vice Chair of Pathology, Professor of Medicine, Pathologist-in-Chief, Vanderbilt University Hospital

List of Tables

Table 3.1. Pharmacogenomic Biomarkers in Drug Labels
Table 3.2. Selected Companies Marketing Antibodies and/or Tests for Estrogen Receptor (ER) and Progesterone Receptor (PR) in Breast Cancer Tissue
Table 3.3. Selected Companies Marketing Tests or Reagents for Detection of HER2 Overexpression
Table 3.4. Selected Companies Marketing Multigene Tests for Breast Cancers
Table 3.5. Selected Companies Marketing Multigene Tests for Other Cancers (Besides Breast Cancer)
Table 3.6. Selected Companies Marketing Tests for Determination of Epidermal Growth Factor Receptor (EGFR) Mutations or Overexpression
Table 3.7. Selected Companies Marketing Tests for Determination of KRAS Mutations
Table 3.8. Selected Companies Marketing Tests for Determination of BRAF Mutations
Table 3.9. Selected Companies Marketing Tests for Determination of DPYD and TYMS Gene Variants
Table 3.10. Selected Companies Marketing Tests for Biomarkers of Hematological Cancers
Table 3.11. Selected Companies Marketing Tests for Determination of Thiopurine Methyltransferase (TPMT) Mutations or Activity
Table 3.12. Cytochrome P450 Drug Interactions and Substrates
Table 3.13. Selected Companies Marketing Tests or Reagents for Detection of Genetic Variants of Cytochrome P450 [Not Including Warfarin Tests]
Table 3.14. Selected Companies Marketing Tests for Detection of UGT1A1 Variants
Table 3.15. Selected Companies Marketing Tests for Detection of CYP2C0 and VKORC1 Genes for Warfarin Sensitivity Testing
Table 3.16. Selected Companies Marketing Personalized Medicine Tests for CNS Applications
Table 3.17. Selected Companies Marketing Other Personalized Medicine Drug/Diagnostic Combination Tests
Table 4.1. Selected Companies Developing Personalized Medicine Diagnostics in Oncology
Table 4.2. Selected Companies Developing Personalized Medicine Diagnostics in Other (Non-Oncology) or Non-Specified Applications
Table 4.3. Selected Companies Applying Next-Generation Sequencing to Personalized Medicine
Table 4.4. Selected Agreements Between Pharmaceutical/Biopharmaceutical Companies and Diagnostic Companies in Personalized Medicine
Table 4.5. Selected Other Diagnostic Company Agreements in Personalized Medicine
Table 8.1. Percent of Survey Respondents in Management Positions