Xiamen, China, September 4th, 2024 – Amoy Diagnostics Co., Ltd. (AmoyDx), a leading company in molecular diagnostics, proudly announces that its AmoyDx® FGFR2 Break-apart FISH Probe Kit has been approved as a companion diagnostic (CDx) for Eisai’s innovative targeted therapy, Tasurgratinib in Japan. This approval marks a significant milestone in precision oncology, enhancing the treatment options for biliary tract cancer patients with FGFR2 gene fusions.
Key Features of AmoyDx® FGFR2 Break-apart FISH Probe Kit:
• Sensitivity and Specificity: The kit provides robust detection of FGFR2 gene fusions with high accuracy, ensuring reliable results.
• Comprehensive Coverage: The dual-color probes offer precise identification of FGFR2 break-apart signals, critical for guiding Tasurgratinib therapy decisions.
Dr. Li-Mou Zheng, Founder and Chairman of AmoyDx, commented “We are thrilled with the approval of our FGFR2 Break-apart FISH Probe Kit as a companion diagnostic for Eisai’s Tasurgratinib. AmoyDx and Eisai have collaboratively developed this FISH kit in parallel with the clinical development of Tasurgratinib in cholangiocarcinoma. This collaboration underscores our commitment to breaking barriers to precision medicine and enhancing cancer care. We believe that this approval will significantly impact the treatment landscape for biliary tract cancer patients with FGFR2 gene fusions in Japan.”
About AmoyDx® FGFR2 Break-apart FISH Probe Kit
About Tasurgratinib (development code E7090)
Discovered in-house by Eisai’s Tsukuba Research Laboratories, tasurgratinib is an orally available novel tyrosine kinase inhibitor that demonstrates selective inhibitory activity against fibroblast growth factor receptors (FGFR) FGFR1, FGFR2 and FGFR3. Distinct from prior known FGFR inhibitors, tasurgratinib has a basic structure which lacks the dimethoxyphenyl moiety, and in a kinetic interaction analysis study, it was observed that tasurgratinib demonstrates antitumor effects due to inhibition of kinase activity with a binding mode (Type V) that exhibits rapid and potent binding as well as high selectivity to FGFR.1,2 In December 2023, an application was filed in Japan seeking approval for biliary tract cancer with FGFR2 fusions or rearrangements. In addition, a Phase I clinical trial is underway in Japan in patients with estrogen receptor-positive and HER2-negative breast cancer.
1. Miyano SW. et al., "E7090, a Novel Selective Inhibitor of Fibroblast Growth Factor Receptors, Displays Potent Antitumor Activity and Prolongs Survival in Preclinical Models", Molecular Cancer Therapeutics, 2016, 15, 2630-2639.
2. Kawano S. et al., "Antitumor Activity of Tasurgratinib as an Orally Available FGFR1-3 Inhibitor in Cholangiocarcinoma Models With FGFR2-fusion", Anticancer Research, 2024, 44, 2393-2406.
About Eisai
Eisai’s Corporate Concept is “to give first thought to patients and people in the daily living domain, and to increase the benefits that health care provides.” Under this “human health care (hhc)” Concept, we aim to effectively achieve social good in the form of relieving anxiety over health and reducing health disparities. With a global network of R&D facilities, manufacturing sites and marketing subsidiaries, we strive to deliver innovative products to address unmet medical needs, with a particular focus in our strategic areas of Neurology and Oncology and Global Health. For more information, please visit www.eisai.com, X, LinkedIn and Facebook.
About Amoy Diagnostics
AmoyDx is at the forefront of championing molecular diagnostics for cancer, committed to enhancing patient outcomes worldwide through innovative diagnostic solutions and breaking barriers for global precision oncology adoption. The company is recognized for its excellence in precision medicine, driving advancements in cancer diagnosis through its extensive collaboration with pharmaceutical companies. For more information, please visit www.amoydiagnostics.com, LinkedIn, and X.
For media inquiries, please contact:
Robson Ee
Director, International Business
info@amoydiagnostics.com
https://www.amoydiagnostics.com
Key Features of AmoyDx® FGFR2 Break-apart FISH Probe Kit:
• Sensitivity and Specificity: The kit provides robust detection of FGFR2 gene fusions with high accuracy, ensuring reliable results.
• Comprehensive Coverage: The dual-color probes offer precise identification of FGFR2 break-apart signals, critical for guiding Tasurgratinib therapy decisions.
Dr. Li-Mou Zheng, Founder and Chairman of AmoyDx, commented “We are thrilled with the approval of our FGFR2 Break-apart FISH Probe Kit as a companion diagnostic for Eisai’s Tasurgratinib. AmoyDx and Eisai have collaboratively developed this FISH kit in parallel with the clinical development of Tasurgratinib in cholangiocarcinoma. This collaboration underscores our commitment to breaking barriers to precision medicine and enhancing cancer care. We believe that this approval will significantly impact the treatment landscape for biliary tract cancer patients with FGFR2 gene fusions in Japan.”
About AmoyDx® FGFR2 Break-apart FISH Probe Kit
| (1) Product name | AmoyDx® FGFR2 Break-apart FISH Probe Kit |
| (2) Approval No. | 30600EZX00024000 |
| (3) Purpose of use | Detection of FGFR2 gene fusions in cancer tissues (To use for assist in determining the suitability of patients with biliary tract cancer to prescribe Tasurgratinib) |
| (4) Testing method | FISH |
| (5) Sample | Tissue FFPE |
| (6) Package size | 10 tests/ kit |
| (7) Marketing Authorization Holder | Nihon Stery, Inc. |
| (8) Manufacturer | Amoy Diagnostics Co., Ltd. |
About Tasurgratinib (development code E7090)
Discovered in-house by Eisai’s Tsukuba Research Laboratories, tasurgratinib is an orally available novel tyrosine kinase inhibitor that demonstrates selective inhibitory activity against fibroblast growth factor receptors (FGFR) FGFR1, FGFR2 and FGFR3. Distinct from prior known FGFR inhibitors, tasurgratinib has a basic structure which lacks the dimethoxyphenyl moiety, and in a kinetic interaction analysis study, it was observed that tasurgratinib demonstrates antitumor effects due to inhibition of kinase activity with a binding mode (Type V) that exhibits rapid and potent binding as well as high selectivity to FGFR.1,2 In December 2023, an application was filed in Japan seeking approval for biliary tract cancer with FGFR2 fusions or rearrangements. In addition, a Phase I clinical trial is underway in Japan in patients with estrogen receptor-positive and HER2-negative breast cancer.
1. Miyano SW. et al., "E7090, a Novel Selective Inhibitor of Fibroblast Growth Factor Receptors, Displays Potent Antitumor Activity and Prolongs Survival in Preclinical Models", Molecular Cancer Therapeutics, 2016, 15, 2630-2639.
2. Kawano S. et al., "Antitumor Activity of Tasurgratinib as an Orally Available FGFR1-3 Inhibitor in Cholangiocarcinoma Models With FGFR2-fusion", Anticancer Research, 2024, 44, 2393-2406.
About Eisai
Eisai’s Corporate Concept is “to give first thought to patients and people in the daily living domain, and to increase the benefits that health care provides.” Under this “human health care (hhc)” Concept, we aim to effectively achieve social good in the form of relieving anxiety over health and reducing health disparities. With a global network of R&D facilities, manufacturing sites and marketing subsidiaries, we strive to deliver innovative products to address unmet medical needs, with a particular focus in our strategic areas of Neurology and Oncology and Global Health. For more information, please visit www.eisai.com, X, LinkedIn and Facebook.
About Amoy Diagnostics
AmoyDx is at the forefront of championing molecular diagnostics for cancer, committed to enhancing patient outcomes worldwide through innovative diagnostic solutions and breaking barriers for global precision oncology adoption. The company is recognized for its excellence in precision medicine, driving advancements in cancer diagnosis through its extensive collaboration with pharmaceutical companies. For more information, please visit www.amoydiagnostics.com, LinkedIn, and X.
For media inquiries, please contact:
Robson Ee
Director, International Business
info@amoydiagnostics.com
https://www.amoydiagnostics.com
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