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[IWS] CRS: GENETIC TESTING: BACKGROUND AND POLICY ISSUES [2 March 2015]

IWS Documented News Service

_______________________________

Institute for Workplace Studies-----------------Professor Samuel B. Bacharach

School of Industrial & Labor Relations-------- Director, Institute for Workplace Studies

Cornell University

16 East 34th Street, 4th floor--------------------Stuart Basefsky

New York, NY 10016 -------------------------------Director, IWS News Bureau

________________________________________________________________________

NOTE: Funding for this service ends on 31 March 2015. Postings will end on this date as well.

 

Congressional Research Service (CRS)

 

Genetic Testing: Background and Policy Issues

Amanda K. Sarata, Specialist in Health Policy

March 2, 2015

https://fas.org/sgp/crs/misc/RL33832.pdf

[full-text, 19 pages]

 

Summary

Congress has considered, at various points in time, numerous pieces of legislation that relate to

genetic and genomic technology and testing. These include bills addressing genetic

discrimination in health insurance and employment; precision medicine; the patenting of genetic

material; and the oversight of clinical laboratory tests (in vitro diagnostics), including genetic

tests. The focus on these issues signals the growing importance of public policy issues

surrounding the clinical and public health implications of new genetic technology. As genetic

technologies proliferate and are increasingly used to guide clinical treatment, these public policy

issues are likely to continue to garner attention. Understanding the basic scientific concepts

underlying genetics and genetic testing may help facilitate the development of more effective

public policy in this area.

 

Humans have 23 pairs of chromosomes in the nucleus of most cells in their bodies. Chromosomes

are composed of deoxyribonucleic acid (DNA) and protein. DNA is composed of complex

chemical substances called bases. Proteins are fundamental components of all living cells, and

include enzymes, structural elements, and hormones. A gene is the section of DNA that contains

the sequence which corresponds to a specific protein. Though most of the genome is similar

between individuals, there can be significant variation in physical appearance or function between

individuals due to variations in DNA sequence that may manifest as changes in the protein, which

affect the protein’s function. Many complex factors affect how a genotype (DNA) translates to a

phenotype (observable trait) in ways that are not yet clear for many traits or conditions.

 

Most diseases have a genetic component. Some diseases, such as Huntington’s Disease, are

caused by a specific gene. Other diseases, such as heart disease and cancer, are caused by a

complex combination of genetic and environmental factors. For this reason, the public health

burden of genetic disease, as well as its clinical significance, may be large. Experts note that

society has recently entered a transition period in which specific genetic knowledge is becoming

more integral to the delivery of effective health care. Therefore, the value of and role for genetic

testing in clinical medicine is likely to increase in the future.

 

Policymakers may need to balance concerns about the potential use and misuse of genetic

information with the potential of genetics and genetic technology to improve care delivery, for

example by personalizing medical care and treatment of disease. In addition, policymakers face

decisions about the balance of federal oversight and regulation of genetic tests, patients’ safety,

and innovation in this area. Finally, the need for and degree of federal support for research to

develop a comprehensive evidence base to facilitate the integration of genetic testing into clinical

practice (for example, to support coverage decisions by health insurers) may be debated.

 

Contents

Introduction ...................................................................................................................................... 1

Background ...................................................................................................................................... 1

Policy Issues and Genetic Testing .................................................................................................... 3

Defining “Genetic Test” ............................................................................................................ 3

Policy Issues ........................................................................................................................ 4

What Type of Information Can Genetic Tests Provide? ............................................................ 5

Policy Issues ........................................................................................................................ 6

Evaluating Genetic Tests ........................................................................................................... 7

Policy Issues ........................................................................................................................ 8

The Genetic Test Result ........................................................................................................... 11

Policy Issues ...................................................................................................................... 12

 

Appendixes

Appendix. Fundamental Concepts in Genetics .............................................................................. 14

 

Contacts

Author Contact Information........................................................................................................... 16

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This information is provided to subscribers, friends, faculty, students and alumni of the School of Industrial & Labor Relations (ILR). It is a service of the Institute for Workplace Studies (IWS) in New York City. Stuart Basefsky is responsible for the selection of the contents which is intended to keep researchers, companies, workers, and governments aware of the latest information related to ILR disciplines as it becomes available for the purposes of research, understanding and debate. The content does not reflect the opinions or positions of Cornell University, the School of Industrial & Labor Relations, or that of Mr. Basefsky and should not be construed as such. The service is unique in that it provides the original source documentation, via links, behind the news and research of the day. Use of the information provided is unrestricted. However, it is requested that users acknowledge that the information was found via the IWS Documented News Service.

 

 

 

 

 

 

 

 

 




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