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タイトル: | Recommendations related to the analytical equivalence assessment of gene panel testing |
著者: | Nagai, Sumimasa Nishihara, Hiroshi Suzuki, Takayoshi Nishio, Kazuto Taniguchi, Hiroya Tsuchihara, Katsuya Nakamura, Kohei Takamatsu, Reika Ueno, Toshihide Aburatani, Hiroyuki Kohno, Takashi Kohsaka, Shinji |
著者名の別形: | 永井, 純正 |
キーワード: | companion diagnostic comprehensive genomic profiling liquid biopsy next-generation sequencing pharmaceuticals and medical devices agency |
発行日: | Oct-2022 |
出版者: | Wiley Japanese Cancer Association |
誌名: | Cancer Science |
巻: | 113 |
号: | 10 |
開始ページ: | 3282 |
終了ページ: | 3290 |
抄録: | Advances in cancer genome care over the past few years have included the development of gene panel testing for various biomarkers. This article summarizes issues and provides recommendations related to analytical performance evaluations for new oncology gene panels. The scope of these recommendations includes comprehensive genomic profiling assays related to gene panel testing that uses histological or serum specimens to detect gene mutations. As a research project of the Japan Agency for Medical Research and Development Research on Regulatory Science of Pharmaceuticals and Medical Devices, we convened the working group committee that consisted of more than 30 experts from academia, industry, and government. We have discussed the points that should be considered to allow maximal simplification of assessments using clinical specimens in evaluating accuracy and limit of detection in equivalence and analytical performance for three years. We provide recommendations specific to each type of gene mutation as well as to reference standards or specimens used for evaluations. In addition, in order to facilitate the discussion on the analytical performance of gene panel tests by multidisciplinary tumor boards of hospitals, the present recommendations also describe the items that companies are expected to provide information on in their packaging inserts and reports, and the items that are expected to be discussed by multidisciplinary tumor boards. Our working group document will be important for participants in multidisciplinary tumor boards including medical oncologists and genome scientists, and developers of gene panels not only in Japan but also in other countries. |
著作権等: | © 2022 The Authors. Cancer Science published by John Wiley & Sons Australia, Ltd on behalf of Japanese Cancer Association. This is an open access article under the terms of the Creative Commons Attribution-NonCommercial License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited and is not used for commercial purposes. |
URI: | http://hdl.handle.net/2433/284562 |
DOI(出版社版): | 10.1111/cas.15513 |
PubMed ID: | 35906844 |
出現コレクション: | 学術雑誌掲載論文等 |
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