AmoyDx® Pan Lung Cancer PCR Panel
Receives MHLW Approval as Companion Diagnostic for 9 Targeted Therapies
for Use in Patients with Advanced Non-Small Cell Lung Cancer
TOKYO and XIAMEN, June 30, 2021 (GLOBE NEWSWIRE) -- 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”), an in vitro
diagnostic reagent developed as a companion diagnostic for multiple anti-cancer agents, wasapproved by Ministry of Health, Labour and Welfare (MHLW) for production and marketing inJapan on June 25, 2021.
The AmoyDx® PLC Panel is based on polymerase chain reaction (PCR) technology, and cansimultaneously 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 ascompanion diagnostics. The AmoyDx® PLC Panel has received approval for four driver genes(EGFR, ALK, ROS1, and BRAF) for nine associated targeted therapies in NSCLC. With its highsensitivity and short turnaround time, The AmoyDx® PLC Panel is expected to be an important
clinical diagnostic in guiding treatment opportunities for NSCLC patients.
“We are pleased to collaborate with AmoyDx and PREMIA in obtaining approval of theAmoyDx® PLC Panel in Japan. We will continue to make every effort so that it can be delivered topatients and clinicians in Japan as soon as possible.” said Kenji Iwakabe, president and chief
executive officer of Riken Genesis.
“Both AmoyDx and Riken Genesis have been our long term partners, previously collaborating on
the approval of the single ROS1 CDx for Xalkori in Japan. It is extremely gratifying to have thisopportunity to collaborate again on this fit-for-purpose test that offers accurate and timely
diagnosis of actionable genetic alterations, and designed to lead to better treatment options forpatients,” said Wenn Sun, president and founder of PREMIA.
“The approval of the AmoyDx PLC Panel marks the time that Japanese patients will have directaccess to a locally administered multi-gene PCR CDx with a very short turnaround time fromsample to diagnosis.” said Li-Mou Zheng, Ph.D., Founder and CEO of AmoyDx. “Our goal at AmoyDx
has always been to develop the highest regulatory-grade cancer diagnostics which have greatest
impact in a clinical setting. We are grateful for this collaboration with our regional partners Riken
Genesis and PREMIA to help expand access to timely therapy options for Japanese patients.”

About AmoyDx PLC Panel:(1) Product name

AmoyDx® Pan Lung Cancer PCR Panel(2) Approval No.

30300EZX00059000(3) Purpose of use

Detection of EGFR gene mutations, ALK fusion gene, ROS1 fusion gene,and BRAF gene mutations 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(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 HolderRiken 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 inthe 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 tomeet this U.S. quality control standard for clinical laboratories. For more information, please visit
www. rikengenesis.jp
About AmoyDx (SZSE: 300685)
Amoy Diagnostics Co., Ltd. is a pioneer and globally leading company in the field of moleculardiagnostics for precision oncology, focusing on companion diagnostics product development andcommercialization. A rich product portfolio has been established with more than twenty f
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 technologicalplatforms and full capability for companion diagnostics product development andcommercialization, AmoyDx has become an important diagnostics partner of many pharmaceuticalcompanies 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 anddiagnostics 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 13,000 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.
more information, please visit www.premia-inc.com
Contacts:
Yuko Oi
General Manager, Marketing department
Tel: +81-5759-6042
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

For