Abstract
摘要:藥物基因體學(Parmacogenomics)與陣列(Microarray)為過去10年來最重要的科技突破,它們在疾病的診斷與治療方面均有重大之應用。但僅有歐盟在2004年9月與美國食品藥物管理局在2004年12月首次核准由Roche藥廠與Affymetrix公司合作開發全球第一個對人體藥物代謝酵素CYP450的藥物基因檢測晶片產品(AmplicChip CYP450 Test)。所以生物晶片是一種根據藥物基因體學與生物資訊所發展的一類新興診斷產品,而且診斷用的生物晶片僅需體外測試而不必進行需要大量資源的臨床試驗,所以生物晶片的研發成本較一般的藥物研發為低。因此,我國應利用此契機全力發展診斷用生物晶片產品的產業,但因生物晶片產品為根據最新所發展出新興的診斷試劑;所以,生物晶片的品質確效及診斷正確性的評估是十分重要的。本計劃將對生物晶片診斷試劑的相關試驗與分析之統計方法進行一系列的介紹。本計劃擬分幾部份進行;第一部份將以實際數據介紹陣列資料的各種統計分析方法,其中包括族群鑑別與預測(Class Prediction),族群發現(Class Discovery),族群比較(Class Co
Abstract: Bioinformatics and microarrays are two of the most important scientific breakthroughs in the last decade. These two emerging technology areas present great potentials in detection of diseases, in treatment of diseases, in identification of varieties or species, and many other applications. However, only EMEA in September 2003 and the US Food and Drug Administration (FDA) in December 2004 approved the first microarray-based product AmpliChip CYP450 test, co-developed by Roche Diagnostics and to Affymetrix, predict the phenotypes of Cytochrome P450 2D6 and 2C19. Biochip products based on heritable DNA markers, mutations, and expression patterns for detection of diseases usually only involve in vitro tests and do not require resource-demanding clinical trials. Therefore, the development cost for biochips is relatively inexpensive as compared to biopharmaceuticals. As a result, biochip products for medical and diagnostic devices provide an opportunity for our country to establish the international standards and put our products on a competitive edge. Because biochip diagnostic products are newly developed in vitro diagnostic device, it is extremely important to validate the quality and diagnostic accuracy of biochip diagnostic products. Therefore, the primary objective of the project is to provide a systematic overview of statistical methods in the design and analysis of biochip diagnostic products. The first part of the project is to introduce the statistical methods with real data for the analysis of expression data from microarray experiments, including methods for class discovery, class comparison, class prediction, and methods for determination of thresholds. The second part includes statistical methods for evaluation of diagnostic accuracy in the presence or absence of clinical truth. The third part of the project is to introduce the methods for determination of sample size required for assessment of diagnostic accuracy of biochip diagnostic products. We will also illustrate the appropriate presentation and interpretation of the analysis results. In addition, we will introduce and provide evaluation of the computer software for analysis of expression data from microarray experiments. Because our project will present a comprehensive overview of statistical methods for evaluation of the quality and accuracy of biochip diagnostic products, it will provide a great help in development and approval of biochip diagnostic products in Taiwan.
Keyword(s)
生物資訊
陣列
診斷正確性
一致性
樣本數
Bioinformatics
Microarray
Diagnostic Accuracy
Agreement
Sample Size