Table of Contents
Chapter 1
- GENETIC TESTING: YESTERDAY AND TODAY
- 1.1. PKU: The First Genetic Test
- Phenylketonuria
- Success with PKU Testing Initiates Screening of Newborns for Other
Inherited Diseases
- Newborn Screening Is the Largest Segment of Testing for Gene-Based
Disorders Today
- 1.2. Societal Issues Emerge as Testing for Genetic Diseases Evolves
- Sickle Cell Trait and Tay-Sachs Disease
- Tay-Sachs Disease: Incidence, Etiology, and Pathogenesis
- Genetic Testing of Asymptomatic Gene Carriers Influences Family
Reproductive Decisions
- The Next Wave of Carrier Screening: Neural Tube Defects, Cystic Fibrosis,
and Huntington' s Disease
- 1.3. NIH Helps Redefine Genetic Testing for a New Age
- Adoption of DNA “Fingerprinting” Is Embraced
- 1.4. BRCA1 and BRCA2: A New Breed of Genetic Testing for Hereditary
Breast and Ovarian Cancer (HBOC
- Background on Hereditary Breast and Ovarian Cancer
- Myriad Genetics Commercializes HBOC Genetic Testing
- DTC Genetic Testing Rapidly Expands Following Myriad' s DTC Marketing
Success
- 1.5. Genetic Testing in Medicine Today
Chapter 2
- TODAY' S REGULATION OF GENETIC TESTING
- 2.1. The Emerging Business Environment
- An Evolving Supply Chain Embracing New Technologies Drives a Growing Need
for Regulatory Reform
- 2.2. Regulatory Oversight
- Several Agencies Have Oversight of Clinical Laboratory Tests and Devices,
but Regulatory Gaps Exist
- An Overview of How Genetic Testing Is Currently Regulated in the United
States
- FDA' s Role Covers Equipment, Reagents, and Laboratory Tests
- Medical Devices and In Vitro Diagnostics (IVDs)
- Analyte Specific Reagents (ASRs)
- Laboratory Developed Tests (LDTs)
- Centers for Medicare & Medicaid Services (CMS) Regulates Laboratories, Their Testing Services, and Their Reimbursement
- The Federal Trade Commission (FTC) Oversees All Print, Media, and Internet Advertising
- The CDC' s Role Is Primarily One of Scientific Advisor
- DHHS Addresses Issues Associated with Genetic Testing under the Secretary' s Advisory Committee on Genetics,Health, and Society (SACGHS)
- 2.3. Business Implications
- The US Federal Regulatory Environment Favors Entrepreneurial Genetic
Testing Companies
- .....But Each of the 50 States Has Its Own Suite of Regulations, Creating
Confusion for DTC Companies
- Recent Regulatory Initiatives: States Step In When Federal Regulators
Appear Slow to Act
- New York State Quietly Begins the Challenges
- California' s Recent Citations to DTC Companies Were Accompanied by Print Media and Online Fanfare, Especially in the Gene-Blogosphere Community
- What Was At Stake for Personal Genomics Companies in the California Order?
- How Did Companies Respond to Regulatory Challenges?
- The Outcome and Remaining Issues
- Implications of the California Decision
- What Remaining Issues Could Surface With Other State or Federal Regulators
- Personal Information Services versus Medical Testing Data
- How Are a “Diagnostic” or Clinical Laboratory Test and an “Authorized Provider” Legally Defined?
- Does Telling Someone They Have a Certain Genetic Profile, or Providing Them With a Genetically Based Disease-Risk Assessment, Constitute Relevant Clinical Information?
- California Regulators, As Well As Others in the Medical and Federal Policy Communities, Have Argued That DTC Genetic Testing Companies Pose a Danger to Consumers
- 2.4. The Regulatory Outlook: Federal Regulation Grows More Likely
- Congressional Activities
- What Lies Ahead
- 2.5. Points to Ponder for Personal Genomics Companies
- 2.6. The Genetic Information and Non-Discrimination Act of 2008
(GINA)
- GINA Removes Some, But Not All, Concerns Relating to
- Protection from Genetic Discrimination
Chapter 3
- DIRECT-TO-CONSUMER GENETIC TESTING: THE INDUSTRY TODAY
- 3.1. Will Medical Genetics Evolve To A Consumer Business?
- The “Distribution Revolution”
- 3.2. Direct-To-Consumer Genetic Testing Companies
- Industry Segmentation Today
- Law Enforcement/Forensics
- “Recreational Genomics/Genetics
- Ancestry/Genealogy Testing
- Personal Traits
- Nutritional Genetics/Genomics
- A Dynamic and Fluid Marketplace
- 3.3. For Personal Genomics, Myriad Genetics Helps Set the Stage
- 3.4. Direct-To-Consumer Genetics and Genomics: Personal Genomics
Companies Launched in November 2007
- New Genome-Scan Entrants Celebrated Their First Birthday in November 2008
- 23andMe
- Navigenics
- deCODEme
- Knome
- 3.5. Other DTC Genetic Testing Companies Debuted a Little Earlier, With
Less Fanfare
- DNA Direct
- Other Genetic Testing Companies Abound
Chapter 4
- UNDERSTANDING CONSUMERS.....THE BIGGEST VARIABLE IN THE PERSONAL
GENOMICS BUSINESS EQUATION
- 4.1. A Survey Sampling: Attitudes about Genetics, Genomics, and Genetic
Testing Among Different Consumer Groups
- Burrill & Company/ChangeWave Research' s Personalized Medicine and Wellness
Survey, May 2008
- Cogent Research' s “Cogent Genomics Attitudes and Trends”
(CGAT) Survey, 2008
- 4.2. Consumer Segmentation: Sorting the US Population by Opinions,
Attitudes, and Values Regarding Use of Genetic Information for Health
Optimization
- 4.3. Physician Market Research: Important, But Still Limited
- 4.4. The Bottom Line Derived From Preliminary Research
Chapter 5
- THE BUSINESS OUTLOOK FOR DIRECT-TO-CONSUMER GENETIC TESTING
- 5.1. Rapid Technology Change
- The Archon X Prize
- The Race to Commoditization.....The $1,000 Genome
- Information Overload: So We Can Sequence an Entire Human Genome.....Now
What?
- 5.2. Likely Regulation
- 5.3. An Uncertain Future with Consumers
- 5.4. Will Consumer Genomics Be a Means to a Different End?
Chapter 6
- EXPERT INTERVIEWS
- 6.1. Linda Avey, Cofounder, 23andMe, Mountain View, CA
- 6.2. Mari Baker, Chief Executive Officer, Navigenics, Redwood Shores, CA
- 6.3. George Church, PhD, Professor of Genetics, Harvard Medical School,
Director, Lipper Center for Computational Genetics, Boston, MA; Founder,
Knome, Cambridge, MA
- 6.4. Fred Ledley, MD, Professor and Chair, Natural Sciences Department,
Bentley University; Founder and Chair of My Genome
- 6.5. Gilbert Leveille, PhD, Executive Director, Wrigley Science Institute,
William Wrigley Jr. Company, Chicago, IL; Scientific Advisory Board Member,
Sciona, Aurora, CO
- 6.6. Ryan Phelan, Chief Executive Officer, DNA Direct, San Francisco, CA
- 6.7. Dietrich Stephan, PhD, Cofounder and Chief Science Officer,
Navigenics, Redwood Shores, CA
- 6.8. Peter Vitulli, Chief Executive Officer, Sciona, Aurora, CO
- 6.9. Christy White, Founder and CEO, Cogent Research, Cambridge, MA
Appendix A
- RECOMMENDED NEWBORN SCREENING TESTS FOR US BIRTHS
Appendix B
- GENERIC COPY OF CALIFORNIA DEPARTMENT OF PUBLIC HEALTH' S
“CEASE-AND-DESIST” LETTER SENT TO 13 GENETIC TESTING COMPANIES
Appendix C
- SELECTED COMPANY PROFILES
- 23andMe
- Management Summary and Board of Directors
- Company Vision and Mission
- Genetic Testing Services
- BioMarker Pharmaceuticals
- Company Description
- Products and Services
- Dietary Supplement Products
- Management Team
- Board of Directors
- Scientific Advisory Board
- Technology Platforms
- Consumer Genetics
- Company Description and Mission
- Management
- CyGene Direct (CyGene Laboratories)
- Background and Description
- Mission and Vision
- Products and Services Offered (since 2006)
- Management
- Technology Developments
- Alliances
- Scientific Advisory Board
- Financial Summary
- deCODE genetics
- Company Description
- Recent Scientific Developments
- Financial Summary
- DNA Direct
- Company Description
- Mission
- Business Model
- Company Standards and Criteria for Offered Tests
- The Test Purchasing Process
- Privacy and Security
- Investors
- Management
- Services Offered
- Other Company Initiatives
- Board of Directors
- Medical Advisors
- Genelex Corporation
- Company Description
- Company Mission
- Products and Services
- Awards and Recognition
- Company Licenses
- Management
- Other Products Offered
- Knome
- Company Description
- Partnerships
- Management and Advisors
- Technology
- Products and Services
- LabCorp
- Company Description
- Management Team
- Board of Directors
- Genetic Testing Capabilities
- LifeCode
- Company Description
- Navigenics
- Company Background
- Management
- Mission and Vision
- Genetic Testing Services
- Other Information
- Navigenics' Clinical Advisory Board
- Navigenics' Scientific Advisory Board
- Navigenics' Genetics Counseling Task Force
- Navigenics' Policy and Ethics Task Force
- Sciona
- Company Description
- Investors
- Products and Services
- Management
- Technology
- Board of Directors
- Scientific and Business Advisory Board
- Current Research Collaborations
- SeqWright
- Company Description
- Mission
- Products and Services
- Overview of Genomic Profiling Service
- Professional Staff
- Scientific Advisory Board
- Regulatory Compliance
- Smart Genetics
- Company Description
- Mission
- Management Team
- Board of Trustees
- Expert Advisors
- Product Offerings
- Suracell
- Company Description
- Management and Advisory Team
- Product Lines
- Partnerships
- Financial Summary
- References
- Company Index with Web Addresses
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