Sunday, July 11, 2004 7:22:36 AM
http://times.hankooki.com/lpage/200407/kt2004071117455612070.htm
DNA Chips to Be Used for Medical Use
By Kim Rahn
Staff Reporter
DNA chips, developed by local biotechnology firms for disease diagnosis, will be approved for medical use as early as this month.
The Korea Food and Drug Administration (KFDA) said yesterday that it has recently finished safety tests on DNA chips developed to detect human papillomavirus (HPV) by two local biomedical venture companies, Biomedlab and Mygene.
The KFDA added it will approve the usage of the chips for medical purposes within this month as soon it completes inspections on the firms’ production facilities.
As HPV is reported to cause cervical cancer and other cancers, the DNA chips for HPV detection, if approved, will be useful for the early diagnosis of cervical cancer, which can be completely cured if treated in its early stage.
A KFDA official said the approval of the DNA chips will be the first of its kind in Korea as well as in the world.
The drug administration has worked to set up guidelines for biotechnological products and designate DNA chips as medical supplies since 2001. It has established regulations for biochips and analyzing facilities, and codes to classify those products.
Biomedlab and Mygene have developed several kinds of DNA chips since 2000. However, the chips have been used only for research purposes and not for medical diagnosis, as there have been no classifying codes or guidelines for those products.
rahnita@koreatimes.co.kr
Here are the websites for the two companies:
http://english.mygene.net
http://www.bmelab.co.kr/eng/index.asp
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