TOKYO and XIAMEN, April 20, 2022 -- Riken Genesis Co., Ltd., (“Rigen Genesis”), Amoy Diagnostics Co., Ltd., (“AmoyDx”) and Precision Medicine Asia Co., Ltd. (“PREMIA”) today announced that in April 2022, AmoyDx® Pan Lung Cancer PCR Panel (the “AmoyDx PLC Panel”), an in vitro diagnostic reagent for multiple antineoplastic agents, was filed in Japan as a companion diagnostic for RetevmoTM (selpercatinib).
The aim of this application is to obtain approval as a companion diagnostic for RET fusion-positive non-small cell lung cancer (“NSCLC”), for RetevmoTM capsules 40 mg and 80 mg (common name: selpercatinib) marketed by Eli Lilly Japan K.K.
The AmoyDx® PLC Panel is based on polymerase chain reaction (PCR) technology and can simultaneously evaluate the presence of 11 driver genes (EGFR/ ALK/ ROS1/ KRAS/ BRAF/ HER2/ RET/ MET/ NTRK1/ NTRK2/ NTRK3 genes) when all genes on the panel are approved as companion diagnostics. The AmoyDx® PLC Panel has received approval for five driver genes (EGFR, ALK, ROS1, BRAF, and MET exon 14 skipping) for ten associated targeted therapies in NSCLC. If the AmoyDx® PLC Panel is approved for indication for selpercatinib, it is expected to contribute to expanding treatment opportunities for patients with unresectable, advanced, or recurrent RET fusion-positive NSCLC.
“We are pleased to announce this application. We look forward to obtaining marketing approval and expanding access to timely therapy options for Japanese patients,” stated representatives of the three companies- Kenji Iwakabe, President and Chief Executive Officer of Riken Genesis, Li-Mou Zheng, Ph.D., Founder and Chief Executive Officer of AmoyDx and Wenn Sun, Ph.D., Founder and President of PREMIA.
About AmoyDx PLC Panel:
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(1)Product name |
AmoyDx® Pan Lung Cancer PCR Panel |
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(2)Approval No. |
30300EZX00069000 |
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(3)Purpose of use |
Detection of EGFR gene mutations, ALK fusion gene, ROS1 fusion gene, BRAF gene mutations and MET exon 14 skipping mutation in nucleic acids extracted from cancer tissue Used as an adjunct to determine the indications of the following nine antineoplastic agents for patients with NSCLC. ・EGFR gene mutation Gefitinib, Erlotinib hydrochloride, Afatinib maleate, Osimertinib mesylate ・ALK fusion gene Crizotinib, Alectinib hydrochloride, and Brigatinib ・ROS1 fusion gene Crizotinib ・BRAF V600E mutation Combined administration of Dabrafenib mesilate and Trametinib dimethyl sulfoxide ・MET exon14 skipping mutation Tepotinib |
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(4)Testing method |
Real-time PCR |
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(5)Sample |
FFPE tissue and fresh frozen tissue in which the presence of tumor cells was confirmed |
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(6)Package size |
12 tests / kit |
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(7)Marketing Authorization Holder |
Riken Genesis Co., Ltd. |
|
(8)Manufacturer |
Amoy Diagnostics Co., Ltd. |
About Riken Genesis Co., Ltd.
RIKEN GENESIS, founded in October 2007, provides lab-assay services as well as products for genetic testing based on cutting-edge gene analysis technologies and bioinformatics, and has experience in the field of personalized medicine. The company provides highly reliable tests based on international quality standards, as demonstrated by its CLIA certification, being the first organization in Japan to meet this U.S. quality control standard for clinical laboratories. For more information, please visit www. rikengenesis.jp
About Amoy Diagnostics Co., Ltd. (AmoyDx, SZSE: 300685)
Amoy Diagnostics Co., Ltd. is a pioneer and globally leading company in the field of molecular diagnostics for precision oncology, focusing on companion diagnostics product development and commercialization. A rich product portfolio has been established with more than twenty products approved by China NMPA, EU authority, Japan MHLW, South Korea MFDS, etc. Patients in more than 60 countries are benefiting from AmoyDx products. With multiple technological platforms and full capability for companion diagnostics product development and commercialization, AmoyDx has become an important diagnostics partner of many pharmaceutical companies over the globe. For more information, please visit www.amoydiagnostics.com.
About Precision Medicine Asia (PREMIA)
PREMIA offers an integrated platform for the development of innovative oncology therapies and diagnostics in Asia, the fastest growing market for the pharmaceutical industry. PREMIA also manages Japan’s nation-wide, clinical-genomic lung cancer registry, the only such database in Asia. The registry currently includes more than 15,000 patients and allows an efficient patient identification process for clinical trial enrollment through participation by more than 200 hospitals in Japan and Taiwan, with the expected addition of hospitals in Southeast Asia during 2022. For more information, please visit www.premia-inc.com
Contacts:
Yuko Oi
General Manager, Marketing department
Tel: +81-3-5759-6042
yuko.oi@rikengenesis.jp
Paul Huang
Director, International business
Tel: + 86-592-6806058
paulhuang@amoydx.com
Vivian Liu
Director, Corporate Operation
Tel: 852-3978-2288
vliu@premia-inc.com
