AmoyDx® Pan Lung Cancer PCR Panel
Approved in Japan as a Companion Diagnosticfor TABRECTATM (Capmatinib)

TOKYO and XIAMEN, May 20th, 2024 -- Riken Genesis Co., Ltd., Amoy Diagnostics Co., Ltd.,(“AmoyDx”) and Precision Medicine Asia Co., Ltd. (“PREMIA”) today announced that the Japanese
Ministry of Health, Labour and Welfare (MHLW) has approved the AmoyDx® Pan Lung Cancer PCR
Panel (the “AmoyDx PLC Panel”) as a companion diagnostic for TABRECTATM (capmatinib) aproduct of Novartis AG, Basel, Switzerland which was approved by the Japanese MHLW in June
2020. Designed for patients battling unresectable, advanced, or recurrent non-small cell lungcancer (NSCLC) with MET exon 14 (METex14) skipping alterations, TABRECTATM tablets areavailable in 150 mg and 200 mg dosages.
Engineered using cutting-edge PCR technology, the AmoyDx® Panel enables the simultaneous
detection of activation alterations across 11 critical driver genes (EGFR, ALK, ROS1, KRAS, BRAF,HER2, RET, MET, NTRK1, NTRK2, NTRK3) and identifies actionable mutations in seven of thesegenes (EGFR, ALK, ROS1, BRAF, METex14 skipping, KRAS, RET) directly linked to twelve targeted
NSCLC therapies. This approval signifies a transformative step forward in precision cancer
treatment, combining rapid, sensitive detection with the potential to significantly enhancepatient outcomes.
“With this approval, the AmoyDx® PLC Panel can be used to identify advanced NSCLC patients
harboring alterations leading to METex14 skipping for treatment with capmatinib, thereby
expanding their therapeutic options. We look forward to developing and commercializing
additional, 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 ofAmoyDx and Wenn Sun, Ph.D., Founder and President of PREMIA.

About AmoyDx PLC Panel:(1) Product name

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

30300EZX00069000(3) Purpose of use

Detection of EGFR gene mutations, ALK fusion gene, ROS1 fusion gene,
BRAF gene mutations, MET exon 14 skipping mutation, KRAS genemutations and RET fusion genes in nucleic acids extracted from cancer
tissueUsed 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, Entrectinib
・BRAF V600E mutation
Combined administration of Dabrafenib mesylate and Trametinib
dimethyl sulfoxide
・MET exon 14 skipping mutation
Tepotinib, Capmatinib(TABRECTATM)
・KRAS G12C mutation
Sotorasib
・RET fusion gene
Selpercatinib(4) Testing methodReal-time PCR(5) Sample

FFPE tissue and fresh frozen tissue in which the presence of tumor
cells was confirmed(6) Package size(7) Marketing
Authorization Holder(8) Manufacturer

12 tests / kit
Riken Genesis Co., Ltd.
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 Amoy Diagnostics Co., Ltd. (AmoyDx, SZSE: 300685)
AmoyDx is at the forefront of championing molecular diagnostics for cancer, committed toenhancing patient outcomes worldwide through innovative diagnostic solutions and breaking
barriers for global precision oncology adoption. The company is recognized for its excellence inprecision medicine, driving advancements in cancer diagnosis through its extensive collaboration
with pharmaceutical companies. For more information, please visit www.amoydiagnostics.com.
About Precision Medicine Asia (PREMIA)PREMIA offer an integrated platform for the development of innovative oncology therapies anddiagnostics in Asia, the fastest growing market for the pharmaceutical industry. PREMIA also
manages a clinical-genomic lung cancer registry, the largest in the region, which includes morethan 19,000 patients and allows an efficient patient identification process for clinical trial
enrollment through participation by more than 200 hospitals in Japan, Taiwan, Malaysia andThailand. For more information, please visit www.premia-inc.com

Contacts:Tatsuro Saito
General Manager, Marketing department
Tel: +81-3-5759-6042
info2@rikengenesis.jp

Robson Ee
Director, International Business

Info@amoydiagnostics.com

Vivian Liu
Director, Corporate Operations
Tel: 852-3978-2288
vliu@premia-inc.com