TY - JOUR
T1 - Multiplex gene-panel testing for lung cancer patients
AU - Yatabe, Yasushi
AU - Sunami, Kuniko
AU - Goto, Koichi
AU - Nishio, Kazuto
AU - Aragane, Naoko
AU - Ikeda, Sadakatsu
AU - Inoue, Akira
AU - Kinoshita, Ichiro
AU - Kimura, Hideharu
AU - Sakamoto, Tomohiro
AU - Satouchi, Miyako
AU - Shimizu, Junichi
AU - Tsuta, Koji
AU - Toyooka, Shinichi
AU - Nishino, Kazumi
AU - Hatanaka, Yutaka
AU - Matsumoto, Shingo
AU - Mikubo, Masashi
AU - Yokose, Tomoyuki
AU - Dosaka-Akita, Hirotoshi
N1 - Funding Information:
The authors declare the following financial support or relationships. Dr. Yatabe reports speakers’ fees from Thermo Fisher Scientific, Chugai‐Pharm and Sysmex; Dr. K. Goto, speakers’ fees from Chugai Pharmaceutical Co., Ltd., Astra Zeneka K.K and Novartis Pharma K.K., and research grants from Taiho Pharmaceutical Co., Ltd., Chugai Pharmaceutical Co., Ltd., Ono Pharmaceutical Co., Ltd., AstraZeneca K.K., Sumitomo Dainippon Pharma Co., Ltd., Bristol‐Myers Squibb K.K., Eisai Co., Ltd., DAIICHI SANKYO Co., Ltd., Kyowa Hakko Kirin Co.,Ltd., Takeda Pharmaceutical Co., Ltd., Eli Lilly Japan K.K., Merck Biopharma Co., Ltd., Janssen Pharmaceutical K.K., Loxo Oncology, Inc., Amgen Inc., MEDICAL & BIOLOGICAL LABORATORIES CO., LTD., ignyta inc., NEC Corporation., and Amgen Astellas BioPharma K.K; Dr K. Nishio, speakers’ fees from Boehringer Ingelheim Japan, AstraZeneca, Chugai and research grants from Chugai, Boehringer Ingelheim Japan and Pfizer; Dr. Tsuta, speakers’ fees from AstraZeneca, Chugai Roche, and MSD, and research grants from Ono Pharmaceutical Co., Ltd; Dr. Toyooka, speakers’ fees from Chugai‐Pharm and Novartis Pharma; Dr. Nishino, speakers’ fees from AstraZeneca and Chugai pharmaceutical; Dr. Hatanaka, speakers’ fees from AstraZeneca and Novartis, and research grants from Sysmex and Thermo Fisher Scientific; Dr. Matsumoto, speakers’ fees from Thermo Fisher Scientific and Chugai‐Pharm, and research grant from Chugai‐Pharm; Dr. Satouchi, speakers’ fee from Chugai‐Pharm, Pfizer, AstraZeneca and research grants from Chugai, Novartis and Pfizer; Dr. Dosaka‐Akita, speakers’ fees from AstraZeneca and Chugai‐Pharm. Drs. Sunami, Shimizu, Ikeda, Aragane, Yokose, Sakamoto, Kinoshita, Kimura, Inoue and Mikubo stated none declared.
Publisher Copyright:
© 2020 Japanese Society of Pathology and John Wiley & Sons Australia, Ltd
PY - 2020/12
Y1 - 2020/12
N2 - The year 2019 was considered to be the first year of cancer genome medicine in Japan, with three gene-panel tests using next-generation sequencing (NGS) techniques being introduced into clinical practice. Among the three tests, the Oncomine CDx Target test was approved under the category of regular molecular testing for lung cancer, which meant that this test could be used to select patients for molecularly targeted drugs. Conversely, the other two tests, NCC OncoPanel and FoundationOne CDx, were assigned to be used under the National Cancer Genome Medicine Network, and implementation was restricted to patients for whom standard treatment was completed or expected to be completed. These NGS tests can detect a series of genetic alterations in individual tumors, which further promotes the development of therapeutic agents and elucidates molecular pathways. The NGS tests require appropriate tissue size and tumor cell content, which can be accessed only by pathologists. In this report, we review the current reimbursement schema in our national healthcare policy and the requirements of the specimens for NGS testing based on the recently published ‘Guidance of Gene-panel Testing Using Next-Generation Sequencers for Lung Cancer’, by the Japanese Society of Lung Cancer.
AB - The year 2019 was considered to be the first year of cancer genome medicine in Japan, with three gene-panel tests using next-generation sequencing (NGS) techniques being introduced into clinical practice. Among the three tests, the Oncomine CDx Target test was approved under the category of regular molecular testing for lung cancer, which meant that this test could be used to select patients for molecularly targeted drugs. Conversely, the other two tests, NCC OncoPanel and FoundationOne CDx, were assigned to be used under the National Cancer Genome Medicine Network, and implementation was restricted to patients for whom standard treatment was completed or expected to be completed. These NGS tests can detect a series of genetic alterations in individual tumors, which further promotes the development of therapeutic agents and elucidates molecular pathways. The NGS tests require appropriate tissue size and tumor cell content, which can be accessed only by pathologists. In this report, we review the current reimbursement schema in our national healthcare policy and the requirements of the specimens for NGS testing based on the recently published ‘Guidance of Gene-panel Testing Using Next-Generation Sequencers for Lung Cancer’, by the Japanese Society of Lung Cancer.
KW - gene-panel test
KW - lung cancer
KW - molecular testing
KW - next-generation sequencing
UR - http://www.scopus.com/inward/record.url?scp=85091132935&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85091132935&partnerID=8YFLogxK
U2 - 10.1111/pin.13023
DO - 10.1111/pin.13023
M3 - Review article
C2 - 32956529
AN - SCOPUS:85091132935
VL - 70
SP - 921
EP - 931
JO - Acta Pathologica Japonica
JF - Acta Pathologica Japonica
SN - 1320-5463
IS - 12
ER -