遺伝子検査の直販：米国におけるビジネス展望

Direct-To-Consumer Genetic Testing: Business Prospects in the United States

発行	Insight Pharma Reports
出版日	2009年03月	商品コード	83742
ページ情報	英文 336 pages
価格	US$ 3,195 換算 ¥ 257,804 (税抜) PDF by E-mail ( Single User License) US$ 3,995 換算 ¥ 322,356 (税抜) PDF by E-mail (Single Site License) US$ 9,950 換算 ¥ 802,865 (税抜) PDF by E-mail ( Multi User License)

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Abstract

The current marketplace for direct-to-consumer (DTC) genetic testing is very dynamic and fluid. At least 42 DTC genetic testing companies have been identified to date, and additional market entrants are likely. Firms marketing and selling genetic tests DTC have numerous factors to consider. This report focuses on health-related decision-making applications of DTC genetic tests and examines various components of this emerging business environment:

The rapidly evolving science and technology
The complex framework of regulatory oversight
Social and ethical issues, including genetic privacy
Consumers' attitudes toward genetic testing
Activities of companies shaping this sector
Views of industry leaders through exclusive interviews

Genetic testing has come a long way since development of the first genetic test in 1963. According to the National Institutes of Health, almost 1,500 genetic tests are now in use. Under the traditional business model, tests are performed with a physician' s involvement, from ordering the test to communication of its results. But with the confluence of the Internet and completion of the Human Genome Project, the procurement of genetic tests is migrating from health professional-controlled domains to cyberspace, where these tests are available to anyone. Marketing and selling genetic tests directly to consumers not only adds a new business model that can exclude the consumer' s physician but raises scientific, regulatory, and even ethical issues.

Direct-To-Consumer Genetic Testing: Business Prospects in the United States aims to sort out these complex issues surrounding the consumer business of scanning or sequencing genomes for health-related genetic information. The Washington-level federal dialog has started over the medical legitimacy of the genetic tests offered to consumers, how the information is being used, and the appropriate way to make sure that good scientific, medical, and ethical standards are set and not compromised. We provide a detailed look at the current US regulatory framework and how the “patchwork quilt” of today' s regulations is ripe for reform.

The latest market entrants offering genomic scans or gene sequencing for disease markers or other personal traits currently have similar business models but appeal to very different consumer segments. We compare and contrast the approaches, offerings, and messaging of various DTC genetic testing firms operating today. We delineate aspects of this emerging business environment that current or prospective participants may need to consider, given its short history and its uncertain outlook as the technology evolves, the regulatory dialog continues, and the voices of many groups - including consumers, physicians, scientists, entrepreneurs, and public interest groups - are heard.

Importantly, the voice of the consumer cannot be understated. Direct-To-Consumer Genetic Testing: Business Prospects in the United States presents a sample of the more recent and relevant research that has been conducted on consumers' attitudes toward genetic testing, exploring such issues as their willingness and motivation to have a genetic test, how much they would pay for it, who they would share the results with, privacy concerns, and how important they believe physician involvement is. This information is complemented by in-depth interviews with the industry' s thought leaders and pioneers, who share their views on current business dynamics and directions in which the field may go.

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