Promoting Safe and Effective Genetic Testing in the United States Table of Contents Final Report of the Task Force on Genetic Testing

The Task Force was created by the National Institutes of Health-Department of Energy Working Group on Ethical, Legal and Social Implications of Human Genome Research.

September 1997

EDITORS Neil A. Holtzman, M.D., MPH Michael S. Watson, Ph.D.

ACKNOWLEDGEMENTS

EXECUTIVE SUMMARY

ENSURING THE SAFETY AND EFFECTIVENESS OF NEW GENETIC TESTS

ENSURING THE QUALITY OF LABORATORIES PERFORMING GENETIC TESTS

IMPROVING PROVIDERS' UNDERSTANDINGS OF GENETIC TESTING

GENETIC TESTING FOR RARE INHERITED DISORDERS

Chapter 1: INTRODUCTION

Chapter 2: ENSURING THE SAFETY AND EFFECTIVENESS OF NEW

Chapter 3: ENSURING THE QUALITY OF LABORATORIES PERFORMING GENETIC TESTS

Chapter 4: IMPROVING PROVIDERS' UNDERSTANDINGS OF GENETIC TESTING

Chapter 5: GENETIC TESTING FOR RARE INHERITED DISORDERS

Chapter 6: SUMMARY AND CONCLUSIONS

Appendix 1: Individuals and Organizations Who Provided Comments to the Task Force

Appendix 2: Response of the Task Force to the Food and Drug Administration's Proposed Rule on Analyte Specific Reagents

Appendix 3: State of the Art of Genetic Testing in the United States: Survey of Biotechnology Companies and Nonprofit Clinical Laboratories and Interviews of Selected Organizations

Appendix 4: Informational Materials about Genetic Tests

Appendix 5: The History of Newborn Phenylketonuria Screening in the U.S.

Appendix 6: Scientific Advances and Social Risks: Historical Perspectives of Genetic Screening Programs for Sickle Cell Disease, Tay-Sachs Disease, Neural Tube Defects and Down Syndrome, 1970-1997

GLOSSARY

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Last Reviewed: October 1, 2012

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