Introduction
Introduction
Our Mission
Greetings from the President
Greetings from the Director
Our Mission
Main Responsibilities
Our Mission
The importance of quality control in genetic testing
  • Following the development of life science, genetic testing has gained popularity as a standard procedure in medical and research practice. The automation of equipment such as real-time PCR , large-capacity sequence interpreters and automated chromosome analyzers are also accelerating.
  • While the systematic assessment of the clinical significance of the rapidly developing genetic testing techniques have not yet been sufficiently conducted, there is also a paucity of guidelines regarding the facilities, equipment and human resource s in genetic testing agencies, which has led to growing concerns about the potential adverse effects among patients and their families due to inaccurate testing, as well as on the development of the healthcare industry.
  • Not only is genetic testing intricate in itself, but the breadth of the obtained genetic information carries the potential to be leaked or exploited for alternative purposes. Furthermore, the genetic information of the subject is also related to the genetic information of the subject’s family. For these reasons, there is a need for close supervision and management.
  • The need for systematic management of genetic testing agencies at the national level has been raised continuously following reports of some for-profit testing agencies indiscriminately conducting genetic tests related to body composition, aptitude, intelligence, personality, obesity and disease prediction to the general public, for which scientific evidence is unclear and can lead to misinformation. Furthermore, an abundance of false claims and exaggerated advertisements have been noted, along with the spread of “biological determinism,” a belief that genes determine physiology, behavior and even fate.
The establishment of KIGTE : Background and purpose
  • In response to the aforementioned problems, the government enacted the ‘Bioethics and Safety Act’ in 2005 and established protocols to manage the protection of personal information, the regulation of the commercial use of unwarranted genetic tests and the accuracy of genetic testing agencies (Article 49, Paragraph 3 and Article 48, Paragraph 1 of the Enforcement Regulation of the same Act).
  • The KIGTE is a “genetic testing agency quality assessment organization” with a government designation to perform accuracy evaluations on genetic testing agencies to prevent the confusion that may arise from indiscriminate and inaccurate genetic testing results.
The establishment of KIGTE: Process
  • A policy review by the Korea Institute for Health and Social Affairs revealed the need to assess the accuracy of genetic testing protocols (October 2001), which was enacted in January 2004: the establishment of an organization dedicated to quality control led by private, non-profit public interest groups that expanded existing quality control programs and involving related experts was proposed.
  • Additional request for participation from the Korean Society for Laboratory Medicine (KSLM), which has previously voluntarily performed quality control of clinical pathology tests including genetic tests (May 2004).
  • From June 2004, three organizations related to quality control - KSLM, the Korean Society of Pathologists (KSP) and the Korean Association of External Quality Assessment Service (KEQAS) - along with the Korean Society for Legal Medicine, sought to establish KIGTE, a non-profit foundation. The Korean Society for Medical Genetics and Genomics (KSMG) joined in March 2005.
  • The founding general meeting for the establishment of KIGTE held on June 29, 2005.