AmoyDx® Lung Cancer Multi-gene PCR Panel" Receives Additional Approval for Irresectable, Advanced/Recurrent Non-Small Cell Lung Cancer with EGFR Exon 20 Insertion Mutation, for Use with Rybrevant® or Livribif® in Combination with Chemotherapy
Riken Genesis Co., Ltd. announced on April 28, 2026, that its in vitro diagnostic "AmoyDx® Lung Cancer Multi-gene PCR Panel" received partial change approval for manufacturing and marketing. This allows its use as a companion diagnostic for specific combination therapies (Rybrevant® or Livribif® with chemotherapy) for non-small cell lung cancer patients with EGFR exon 20 insertion mutations, expanding treatment options.
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- 📰 Published: May 2, 2026 at 00:00
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Riken Genesis Co., Ltd. (Headquarters: Shinagawa-ku, Tokyo; President and CEO: Yuko Oi; hereinafter "the Company") is pleased to announce that it has obtained a partial change approval for the manufacturing and marketing of the in vitro diagnostic "AmoyDx® Lung Cancer Multi-gene PCR Panel" (hereinafter "this product") as of April 28, 2026.
This approval allows the use of this product as a companion diagnostic*1 for unresectable, advanced/recurrent non-small cell lung cancer with EGFR exon 20 insertion mutations, specifically for combination therapy with "Rybrevant® IV Infusion 350mg" (generic name: amivantamab [recombinant]) or "Livribif® Subcutaneous Injection" (generic name: amivantamab [recombinant]/volhyaluronidase alfa [recombinant]), which are bispecific antibodies targeting epidermal growth factor receptor (EGFR) and mesenchymal-epithelial transition factor (MET) (manufactured and marketed by Johnson & Johnson; corporate name for pharmaceutical business in Japan: Janssen Pharmaceutical K.K., Headquarters: Chiyoda-ku, Tokyo) and chemotherapy (carboplatin and pemetrexed disodium).
This product is an in vitro diagnostic based on real-time PCR method, targeting 7 driver genes (EGFR, ALK, ROS1, BRAF, MET, KRAS, RET) associated with non-small cell lung cancer. It can simultaneously detect EGFR gene mutations, ALK fusion genes, ROS1 fusion genes, BRAF gene mutations (V600E), MET gene exon 14 skipping mutations, KRAS gene mutations (G12C), and RET fusion genes in a single measurement.
With this approval, this product can now aid in determining the applicability of 20 types of anti-cancer drugs. The addition of its indication as a companion diagnostic for Rybrevant® or Livribif® and chemotherapy combination therapy is expected to contribute to expanding treatment opportunities for patients with unresectable, advanced/recurrent non-small cell lung cancer with EGFR exon 20 insertion mutations.
The Company will continue to contribute to the further development of precision medicine by developing innovative diagnostic technologies, aiming to realize a future where optimal treatment reaches each individual patient.
[Notes]
*1 Companion Diagnostics (CDx)
In vitro diagnostic drugs that examine biomarkers such as genes to predict the efficacy and dosage of pharmaceuticals before administration. Appropriate use of CDx enables the selection of suitable treatments and pharmaceuticals.
*2 Information regarding the report on pharmaceutical cross-sectionalization and pharmaceuticals for which applicability can be determined by cross-sectional CDx is available from 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 possessing technology, experience, and know-how in personalized medicine, providing genetic analysis services and products utilizing cutting-edge genetic analysis technology and bioinformatics. 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), and RIKEN Venture Capital Co., Ltd., with the aim of widely deploying RIKEN's cutting-edge research results in personalized medicine to society and promoting their practical application in medical 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 following 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
This approval allows the use of this product as a companion diagnostic*1 for unresectable, advanced/recurrent non-small cell lung cancer with EGFR exon 20 insertion mutations, specifically for combination therapy with "Rybrevant® IV Infusion 350mg" (generic name: amivantamab [recombinant]) or "Livribif® Subcutaneous Injection" (generic name: amivantamab [recombinant]/volhyaluronidase alfa [recombinant]), which are bispecific antibodies targeting epidermal growth factor receptor (EGFR) and mesenchymal-epithelial transition factor (MET) (manufactured and marketed by Johnson & Johnson; corporate name for pharmaceutical business in Japan: Janssen Pharmaceutical K.K., Headquarters: Chiyoda-ku, Tokyo) and chemotherapy (carboplatin and pemetrexed disodium).
This product is an in vitro diagnostic based on real-time PCR method, targeting 7 driver genes (EGFR, ALK, ROS1, BRAF, MET, KRAS, RET) associated with non-small cell lung cancer. It can simultaneously detect EGFR gene mutations, ALK fusion genes, ROS1 fusion genes, BRAF gene mutations (V600E), MET gene exon 14 skipping mutations, KRAS gene mutations (G12C), and RET fusion genes in a single measurement.
With this approval, this product can now aid in determining the applicability of 20 types of anti-cancer drugs. The addition of its indication as a companion diagnostic for Rybrevant® or Livribif® and chemotherapy combination therapy is expected to contribute to expanding treatment opportunities for patients with unresectable, advanced/recurrent non-small cell lung cancer with EGFR exon 20 insertion mutations.
The Company will continue to contribute to the further development of precision medicine by developing innovative diagnostic technologies, aiming to realize a future where optimal treatment reaches each individual patient.
[Notes]
*1 Companion Diagnostics (CDx)
In vitro diagnostic drugs that examine biomarkers such as genes to predict the efficacy and dosage of pharmaceuticals before administration. Appropriate use of CDx enables the selection of suitable treatments and pharmaceuticals.
*2 Information regarding the report on pharmaceutical cross-sectionalization and pharmaceuticals for which applicability can be determined by cross-sectional CDx is available from 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 possessing technology, experience, and know-how in personalized medicine, providing genetic analysis services and products utilizing cutting-edge genetic analysis technology and bioinformatics. 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), and RIKEN Venture Capital Co., Ltd., with the aim of widely deploying RIKEN's cutting-edge research results in personalized medicine to society and promoting their practical application in medical 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 following 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