AmoyDx® Pan Lung Cancer PCR Panel Receives MHLW Approval As Companion Diagnostic For TEPMETKO® (tepotinib)
Tokyo and Xiamen (GLOBE NEWSWIRE) - Riken Genesis Co., Ltd., Amoy Diagnostics Co., Ltd., (“AmoyDx”) and Precision Medicine Asia Co., Ltd. (“PREMIA”) today announced that the 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 TEPMETKO® (tepotinib) a Merck KGaA, Darmstadt, Germany product that received approval by the Japanese MHLW in March 2020. TEPMETKO (tepotinib) is approved for use in patients with unresectable, advanced or recurrent non-small cell lung cancer with MET gene exon 14 skipping alterations.
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. 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.
“We are pleased to collaborate with AmoyDx and PREMIA in obtaining approval of the AmoyDx® PLC Panel in Japan. We will continue to make every effort so that it can be delivered to patients 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 this opportunity to collaborate again on this fit-for-purpose test that offers accurate and timely diagnosis of actionable genetic alterations and is designed to lead to better treatment options for patients,” said Wenn Sun, president and founder of PREMIA.
“The approval of the AmoyDx PLC Panel marks the first time that Japanese patients will have direct access to a locally administered multi-gene PCR CDx with a very short turnaround time from sample 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 the 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. | 30300EZX00069000 |
| (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
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| (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. 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 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 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 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. For more information, please visit www.premia-inc.com.
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Source: PREMIA Holdings (HK) Ltd.