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Regulatory Issues for Genetic Testing in Clinical Practice.

Kristoffersson, Ulf LU (2008) In Molecular Biotechnology 40. p.113-117
Abstract
Whereas deliver of health care is nationally based with great differences in ways of service provision and financing between countries, and thus not subject to international regulations, genetic testing has become more exposed to international regulations and conventions. This is due to an interest of protecting the individual for abuse by inappropriate use of genetic information, but also to the fact that a specimen from a person aimed for a medical (clinical genetic) test is considered as "tradable goods", and thus also subject to other non-medical associated regulations. There is a substantial transborder flow of samples for genetic testing thus requiring internationally accepted quality standards. Therefore, laboratories acting on an... (More)
Whereas deliver of health care is nationally based with great differences in ways of service provision and financing between countries, and thus not subject to international regulations, genetic testing has become more exposed to international regulations and conventions. This is due to an interest of protecting the individual for abuse by inappropriate use of genetic information, but also to the fact that a specimen from a person aimed for a medical (clinical genetic) test is considered as "tradable goods", and thus also subject to other non-medical associated regulations. There is a substantial transborder flow of samples for genetic testing thus requiring internationally accepted quality standards. Therefore, laboratories acting on an international market need to follow certain rules and regulations, also applicable to obtain high-quality standards nationally. Further, genetic testing for rare disorders is often provided by a limited number of non-commercial laboratories and associated with research programs for the individual disorders. International surveys have revealed that there is a general lack of high standards for quality assurance. This article is aimed to give an introduction and overview of regulations, conventions, and quality standards applicable for the laboratory who is seeking to improve there quality performance. (Less)
Please use this url to cite or link to this publication:
author
organization
publishing date
type
Contribution to journal
publication status
published
subject
in
Molecular Biotechnology
volume
40
pages
113 - 117
publisher
Humana Press
external identifiers
  • pmid:18270847
  • wos:000258192500013
  • scopus:55949106662
ISSN
1559-0305
DOI
10.1007/s12033-008-9041-z
language
English
LU publication?
yes
id
85f287ba-ce9a-4ab0-8fc6-c8ffd8d04776 (old id 1041997)
alternative location
http://www.ncbi.nlm.nih.gov/pubmed/18270847?dopt=Abstract
date added to LUP
2008-03-05 11:09:53
date last changed
2017-03-19 04:21:10
@article{85f287ba-ce9a-4ab0-8fc6-c8ffd8d04776,
  abstract     = {Whereas deliver of health care is nationally based with great differences in ways of service provision and financing between countries, and thus not subject to international regulations, genetic testing has become more exposed to international regulations and conventions. This is due to an interest of protecting the individual for abuse by inappropriate use of genetic information, but also to the fact that a specimen from a person aimed for a medical (clinical genetic) test is considered as "tradable goods", and thus also subject to other non-medical associated regulations. There is a substantial transborder flow of samples for genetic testing thus requiring internationally accepted quality standards. Therefore, laboratories acting on an international market need to follow certain rules and regulations, also applicable to obtain high-quality standards nationally. Further, genetic testing for rare disorders is often provided by a limited number of non-commercial laboratories and associated with research programs for the individual disorders. International surveys have revealed that there is a general lack of high standards for quality assurance. This article is aimed to give an introduction and overview of regulations, conventions, and quality standards applicable for the laboratory who is seeking to improve there quality performance.},
  author       = {Kristoffersson, Ulf},
  issn         = {1559-0305},
  language     = {eng},
  pages        = {113--117},
  publisher    = {Humana Press},
  series       = {Molecular Biotechnology},
  title        = {Regulatory Issues for Genetic Testing in Clinical Practice.},
  url          = {http://dx.doi.org/10.1007/s12033-008-9041-z},
  volume       = {40},
  year         = {2008},
}