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MHLW Approves AmoyDx<sup>®</sup> Pan Lung Cancer PCR Panel as Companion Diagnostic for Rozlytrek<sup>®</sup> (Entrectinib) in Japan

TOKYO and XIAMEN, August 9, 2022 -- Riken Genesis Co., Ltd., Amoy Diagnostics Co., Ltd., (“AmoyDx”) and Precision Medicine Asia Co., Ltd. (“PREMIA”) today announced that the AmoyDx® Pan Lung Cancer PCR Panel (the “AmoyDx PLC Panel”) had been approved by the Ministry of Health, Labour and Welfare (MHLW) as a companion diagnostic to identify patients with ROS1-positive non-small cell lung cancer (NSCLC) for Rozlytrek®, a selective tyrosine kinase inhibitor which comes in 100 mg or 200 mg capsules (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 eleven associated targeted therapies in NSCLC. 

“With this approval, the AmoyDx® PLC Panel can now be used to identify ROS1-positive NSCLC patients for treatment with entrectinib or with crizotinib, hence expanding their options.  We look forward to further developing/offering new therapy options for Japanese patients,” said 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 blocks ROS1 (c-ros oncogene 1) and TRK (neurotrophin receptors) family strongly and selectively. It blocks ROS1 and TRK kinase activity, and inhibits proliferation of cancer cells with ROS1 or NTRK gene fusions. Rozlytrek® was approved for the treatment of locally advanced or metastatic solid tumors that harbor NTRK1/2/3 gene fusions on June 18, 2019. On February 21, 2020, the product 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 fusions, ROS1 fusions, 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

Crizotinib, Alectinib hydrochloride, and Brigatinib

・ROS1 Fusion gene

Crizotinib, Entrectinib

・BRAF V600E mutation

Combined administration of Dabrafenib mesilate and Trametinib dimethyl sulfoxide

・MET exon 14 skipping


(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 www.

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 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

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


Filing Notice for a Manufacturing and Marketing Application for AmoyDx® Pan Lung Cancer PCR Panel as a Companion Diagnostic for a Drug Targeting RET fusion-Positive Non-Small Cell Lung Cancer


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