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

http://www.reportlinker.com/p0156564/Reportlinker-Adds-Direct-To-Consumer-Genetic-Testing-Business-Prospects-in-the-United-States.html#utm_source=prnewswire&utm_medium=pr&utm_campaign=prnewswire

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.

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

Figures and Tables

Figure 2.1. Direct-To-Consumer Genetic Testing: Challenging Traditional Business Models

Figure 2.2. U.S. Department of Health & Human Services Organizational Chart

Figure 4.1. The Health Managment ModelTM

Table 1.1. Myriad Genetics: Genetic Testing Launch Timeline

Table 1.2. Current Applications of Genetic Testing in Medicine

Table 2.1. DTC Genetic Testing Companies In Receipt of Advisory Letters from the NY State Department of Health

Table 2.2. California Issues Cease-and-Desist Orders to 13 DTC Genetic Testing Companies in June 2008

Table 3.1. Genetic Testing and the Internet Foster a "Distribution Revolution"

Table 3.2. Companies Selling Genetic Tests Directly to Consumers Identified Online (as of February 2009)

Table 3.3. National Society of Genetic Counselors' Direct-to-Consumer Genetic Testing Recommendations

Table 3.4. American College of Medical Genetics' Direct-to-Consumer Genetic Testing Guidelines

Table 5.1. Representative Next-Generation Sequencing Companies

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

http://www.reportlinker.com/p0156564/Reportlinker-Adds-Direct-To-Consumer-Genetic-Testing-Business-Prospects-in-the-United-States.html#utm_source=prnewswire&utm_medium=pr&utm_campaign=prnewswire

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    Nicolas Bombourg
    Reportlinker
    Email: nbo@reportlinker.com
    US: (805)652-2626
    Intl: +1 805-652-2626

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