AmoyDx® Pan Lung Cancer PCR PanelApprovedin Japan as a Companion DiagnosticforLUMAKRAS ®...

TOKYO and XIAMEN, November 14th, 2022 -- 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 Amgen’s LUMAKRAS® (sotorasib), for patients with KRASG12C-mutated, unresectable, advanced and/or recurrent non-small-cell lung cancer (NSCLC) that has progressed after systemic anticancer therapy .


The AmoyDx® PLC Panel is based on polymerase chain reaction (PCR)technology and can simultaneously evaluate the presence of11driver genes (EGFR/ ALK/ ROS1/ KRAS/ BRAF/ HER2/ RET/ METexon 14 skipping/ NTRK1/ NTRK2/ NTRK3 genes)when all genes on the panel are approved as companion diagnostics.The AmoyDx® PLC Panel has received approval for six driver genes(EGFR, ALK, ROS1, BRAF, MET exon 14 skipping, and KRASG12C)for twelve associated targeted therapies in NSCLC. With its high sensitivity and short turnaround time, the AmoyDx®PLC Panel is expected to be an important clinical diagnostic in guiding treatment opportunities for NSCLC patients.


“With this approval, the AmoyDx® PLC Panel can now be used to identify KRASG12C positive NSCLC patients for treatment with sotorasib, there by 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 of AmoyDx and Wenn Sun, Ph.D., Founder and President of PREMIA.

About LUMAKRAS®/LUMYKRAS®(sotorasib):


LUMAKRAS®/LUMYKRAS® is an orally available KRASG12C inhibitor. It has demonstrated a positive benefit-risk profile with rapid, deep and durable anticancer activity in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring the KRASG12C mutation with a once daily oral formulation*1.Amgen is progressing the largest and broadest global KRASG12C inhibitor development program with unparalleled speed and exploring more than 10 sotorasib combination regimens with clinical trial sites spanning five continents. To date, over 6,500 patients around the world have received LUMAKRAS®/LUMYKRAS® through the clinical development program and commercial use. In May 2021, LUMAKRAS® was the first KRASG12C inhibitor to receive regulatory approval, anywhere in the world, with its approval in the U.S., under accelerated approval.

*1 Skoulidis F, et al. N Engl J Med. 2021;384:2371-2381.


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 20 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 nationwide, clinical-genomic lung cancer registry, the only such database in Asia. The registry currently includes more than 16,000 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