Notice Concerning Application for Partial Revision of Manufacturing and Marketing Approval of Companion Diagnostic Reagent for the AmoyDx® Pan Lung Cancer PCR Panel
Date:2022-02-24Source: AmoyDx

TOKYO and XIAMEN, February 24, 2022 -- Riken Genesis Co., Ltd., Amoy Diagnostics Co., Ltd., ("AmoyDx") and Precision Medicine Asia Co., Ltd. ("PREMIA") today announced that an application for partial revision of manufacturing and marketing approval for AmoyDx® Pan Lung Cancer PCR Panel (the "AmoyDx PLC Panel"), an in vitro diagnostic reagent for multiple antineoplastic agents, was submitted in February 2022 (hereinafter referred to as the "Application for Partial Change").

The aim of the Application for Partial Change is to obtain approval as a companion diagnostic for ROS1 fusion genes, for the anti-tumor agent/tyrosine kinase inhibitor Rozlytrek® capsules 100 mg and 200 mg (common name: Entrectinib), marketed by Chugai Pharmaceutical Co., Ltd.

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. When ROS1 fusion genes are detected by the AmoyDx® PLC Panel, it helps to determine the therapeutic indication for Crizotinib in patients with ROS1 fusion gene-positive NSCLC. If the AmoyDx® PLC Panel is approved for Entrectinib, it is expected to contribute to expanding treatment opportunities for patients with ROS1 fusion-positive NSCLC. 

“We are pleased to announce this application. We look forward to getting marketing approval in order to help expand 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 Rozlytrek®
Rozlytrek® is an orally available tyrosine kinase inhibitor that strongly and selectively inhibits the ROS1 (c-ros oncogene 1) and the TRK (neurotrophic factor receptor) family. By inhibiting ROS1 and TRK kinase activity, Rozlytrek® inhibits the growth of cancer cells with ROS1 or NTRK fusion genes. On June 18, 2019, Rozlytrek® obtained approval for the indication of "NTRK fusion-positive advanced or metastatic solid tumors," and on February 21, 2020, it obtained approval for the additional indication of "ROS1 fusion gene positive, unresectable, advanced or metastatic non-small cell lung cancer."

About AmoyDx PLC Panel:

(1) Product name

AmoyDx® Pan Lung Cancer PCR Panel

(2) Approval No.


(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


・BRAF V600E mutation

 Combined administration of Dabrafenib mesilate and Trametinib dimethyl sulfoxide

・MET exon14 skipping mutation

 Tepotinib (TEPMETKO®)

(4) Testing method

Real-time PCR

(5) Sample

FFPE tissue and fresh frozen tissue in which the presence of tumor cells was confirmed

(6) Package size

12 tests / kit

(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

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

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 nationwide, 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 2021. For more information, please visit

Yuko Oi
General Manager, Marketing department
Tel: +81-3-5759-6042

Paul Huang 
Director, International business
Tel: + 86-592-6806058

Vivian Liu
Director, Corporate Operation
Tel: 852-3978-2288

For more information, please call us at +86-592-6806835 or email us at

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