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Biochip is defined as miniaturized test sites (microarrays) arranged on a solid substrate
that permits many tests to be performed at the same time in order to achieve higher throughput and speed. Biochip came out through Bio-technology and Information-technology. Over the past few years, korean government has supported biochip industry as a key sector in korea economy. As a consequence, biochip technology and industry has been in bloom since 2000. A number of research groups developed various types of biochips which are applicable to pharmaceutics/medicine as well as basic science, including environmental and biological field. Noticeably, biochip has been proven to be a powerful tool in diagnosing several diseases and is now expanding its share of market rapidly. KFDA has classified biochip as in-vitro diagnostic devices since 2003. While many kinds of diagnostic chips have been reviewed, HPV genotyping DNA chip is the first device to be approved by KFDA for its commercial use in July, 2004. Since then, other similar or upgraded HPV DNA chips has been approved. As with virus diagnostic chips, cancer diagnostic chips have been under developing and we hope these products will be on market in near future. Based on our experience on evaluating Specification and Test
Methods for HPV chips, we now published the new guideline which is intended as a reference for both developer and reviewer. This guideline basically propose the minimum requirement to evaluate the quality of HPV chips and several other documents may be required by reviewer when needed. While US FDA prepares the draft guideline for In-vitro multi-variate index assay, this guideline is the first one specific for HPV. KFDA hope that this guideline is a help for the companies, academic, research institute, and pharmaceutical company which are involved in In-Vitro diagnostic devices. Since this guidance represents the current thinking of KFDA, we are open to comment or advice from related areas.