AmoyDx® Lung Cancer Multi-gene PCR Panel Approved as Cross-sectional Companion Diagnostic for EGFR Gene Mutations in Non-Small Cell Lung Cancer
Riken Genesis Co., Ltd. announced that on April 28, 2026, it obtained a partial change approval for the manufacturing and marketing of its in vitro diagnostic medical device, the "AmoyDx® Lung Cancer Multi-gene PCR Panel." This approval allows the product to be used as a cross-sectional companion diagnostic (CDx) for EGFR gene mutations in non-small cell lung cancer, aiding in the determination of applicability for multiple approved anti-cancer drugs (EGFR molecular targeted therapies), thereby contributing to expanding treatment opportunities for patients.
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Riken Genesis Co., Ltd. (Headquarters: Shinagawa-ku, Tokyo; President and Representative Director: Yuko Oi; hereinafter "the Company") announced that on April 28, 2026, it obtained a partial change approval for the manufacturing and marketing of its in vitro diagnostic medical device, the "AmoyDx® Lung Cancer Multi-gene PCR Panel" (hereinafter "the Product").
With this approval, the Product can now be used as a cross-sectional companion diagnostic (CDx)*1 to assist in determining the applicability of multiple anti-cancer drugs (EGFR molecular targeted therapies) approved for non-small cell lung cancer with EGFR gene mutations.
The Product is an in vitro diagnostic medical device based on the real-time PCR method, targeting 7 driver genes (EGFR, ALK, ROS1, BRAF, MET, KRAS, RET) associated with non-small cell lung cancer. With this approval, the Product can now provide cross-sectional applicability determination assistance for companion diagnostics that were previously approved individually for each anti-cancer drug targeting EGFR gene mutations, which is expected to contribute to expanding treatment opportunities for non-small cell lung cancer patients.
The Company will continue to contribute to the further development of precision medicine, aiming to realize a future where optimal treatment reaches each patient through the development of innovative diagnostic technologies.
[Notes]
*1 Cross-sectional Companion Diagnostic (CDx)
This refers to products that meet the following requirements based on the "Handling of In Vitro Diagnostic Medical Devices for Cross-sectional Companion Diagnostics" (Yakuseiyakushinhatsu No. 0331-1, Yakuseikishinhatsu No. 0331-1, Yakuseianhatsu No. 0331-1, dated March 31, Reiwa 4). Unlike the conventional "one drug, one test" approach, a single test can determine the applicability of multiple drugs, aiming to reduce the physical and economic burden on patients and improve testing efficiency.
Requirements (1) Multiple CDx with the same indications (target disease (cancer type in the case of malignant tumors), biomarker, and specimen type to be tested) are approved.
Requirements (2) Each CDx is approved for the purpose of assisting in the determination of applicability for different drugs.
Requirements (3) The test results of each CDx can be used interchangeably within a scientifically valid range for assisting in the determination of applicability for different drugs.
*2 Reports related to cross-sectionalization and information on drugs for which applicability can be determined by cross-sectional CDx are available on the following website (https://www.pmda.go.jp/rs-std-jp/cross-sectional-project/0013.html).
About Riken Genesis Co., Ltd.:
Riken Genesis is one of the few Japanese companies that possesses technology, experience, and know-how in personalized medicine, utilizing cutting-edge genetic analysis technology and bioinformatics to provide genetic analysis contract services and products. It was established in 2007 through a joint effort by Toppan Printing Co., Ltd. (hereinafter "Toppan Printing," now TOPPAN Holdings Inc.), RIKEN (National Research and Development Agency RIKEN), and RIKEN Venture Capital Co., Ltd., with the aim of widely disseminating RIKEN's cutting-edge research results in personalized medicine to society and promoting their practical application in clinical settings. In 2014, Toppan Printing and Sysmex Corporation (hereinafter "Sysmex") agreed to cooperate with each other for the development of genetic testing business in personalized medicine, and each invested in Riken Genesis. Furthermore, in 2016, it became a subsidiary of Sysmex to realize the clinical implementation of genomic medicine. For more details, please visit the website (https://www.rikengenesis.jp/).
Contact for this matter:
Riken Genesis Co., Ltd., Academic Marketing Department
Atsushi Tsuchiya
Email: info2@rikengenesis.jp
Phone: 03-5759-6042
With this approval, the Product can now be used as a cross-sectional companion diagnostic (CDx)*1 to assist in determining the applicability of multiple anti-cancer drugs (EGFR molecular targeted therapies) approved for non-small cell lung cancer with EGFR gene mutations.
The Product is an in vitro diagnostic medical device based on the real-time PCR method, targeting 7 driver genes (EGFR, ALK, ROS1, BRAF, MET, KRAS, RET) associated with non-small cell lung cancer. With this approval, the Product can now provide cross-sectional applicability determination assistance for companion diagnostics that were previously approved individually for each anti-cancer drug targeting EGFR gene mutations, which is expected to contribute to expanding treatment opportunities for non-small cell lung cancer patients.
The Company will continue to contribute to the further development of precision medicine, aiming to realize a future where optimal treatment reaches each patient through the development of innovative diagnostic technologies.
[Notes]
*1 Cross-sectional Companion Diagnostic (CDx)
This refers to products that meet the following requirements based on the "Handling of In Vitro Diagnostic Medical Devices for Cross-sectional Companion Diagnostics" (Yakuseiyakushinhatsu No. 0331-1, Yakuseikishinhatsu No. 0331-1, Yakuseianhatsu No. 0331-1, dated March 31, Reiwa 4). Unlike the conventional "one drug, one test" approach, a single test can determine the applicability of multiple drugs, aiming to reduce the physical and economic burden on patients and improve testing efficiency.
Requirements (1) Multiple CDx with the same indications (target disease (cancer type in the case of malignant tumors), biomarker, and specimen type to be tested) are approved.
Requirements (2) Each CDx is approved for the purpose of assisting in the determination of applicability for different drugs.
Requirements (3) The test results of each CDx can be used interchangeably within a scientifically valid range for assisting in the determination of applicability for different drugs.
*2 Reports related to cross-sectionalization and information on drugs for which applicability can be determined by cross-sectional CDx are available on the following website (https://www.pmda.go.jp/rs-std-jp/cross-sectional-project/0013.html).
About Riken Genesis Co., Ltd.:
Riken Genesis is one of the few Japanese companies that possesses technology, experience, and know-how in personalized medicine, utilizing cutting-edge genetic analysis technology and bioinformatics to provide genetic analysis contract services and products. It was established in 2007 through a joint effort by Toppan Printing Co., Ltd. (hereinafter "Toppan Printing," now TOPPAN Holdings Inc.), RIKEN (National Research and Development Agency RIKEN), and RIKEN Venture Capital Co., Ltd., with the aim of widely disseminating RIKEN's cutting-edge research results in personalized medicine to society and promoting their practical application in clinical settings. In 2014, Toppan Printing and Sysmex Corporation (hereinafter "Sysmex") agreed to cooperate with each other for the development of genetic testing business in personalized medicine, and each invested in Riken Genesis. Furthermore, in 2016, it became a subsidiary of Sysmex to realize the clinical implementation of genomic medicine. For more details, please visit the website (https://www.rikengenesis.jp/).
Contact for this matter:
Riken Genesis Co., Ltd., Academic Marketing Department
Atsushi Tsuchiya
Email: info2@rikengenesis.jp
Phone: 03-5759-6042