DNA Chip Laboratory Co., Ltd.
Notification of manufacturing and marketing approval for “Lung Cancer Compact Panel (R) Dx Multi-companion Diagnostic System” (medical device program)
On November 16, 2022, DNA Chip Research Institute Co., Ltd.
(President: Ryo Matoba) will manufacture highly controlled medical equipment for the “Lung Cancer Compact Panel (R) Dx Multi-Companion Diagnostic System” (hereinafter referred to as “Lung Cancer Compact Panel”). We are pleased to inform you that we have obtained marketing authorization.
This approval indicates that the “application for manufacturing and marketing approval in Japan for lung cancer compact panels” disclosed on October 28, 2021 has been approved.
We have been working on the development of a highly sensitive batch genetic test that specializes in important genes (driver genes*1) for lung cancer. With the acquisition of manufacturing and marketing approval for the “Lung Cancer Compact Panel,” mutations in 4 genes (EGFR, ALK, ROS1, MET), which are representative driver genes, will be used as a companion diagnosis*3 for lung cancer, especially non-small cell lung cancer patients*2. It will be possible to detect and determine drug indications. This product has been developed based on the results of joint research between the Nara Institute of Science and Technology and the Osaka International Cancer Center.
[Table 2: https://prtimes.jp/data/corp/94032/table/3_1_9c9777b6e9ed5aa9c0b7ef1db9550b36.jpg ]
In the field of research on lung cancer driver genes, the DNA Chip Research Institute is based on the concept of providing an easy-to-use and highly reliable companion diagnostic test that meets the needs of daily clinical practice in Japan. We are working on the
commercialization of As a forerunner, the “Lung Cancer Compact Panel” was developed as a cancer gene panel test for 8 representative driver genes of lung cancer (including research genes), and is currently being introduced into clinical trials, and the results are about to be clarified. is. The features of this test are that it can efficiently measure multiple major genes at once (multi-diagnosis), that it can sensitively detect degraded specimens and specimens with a very small amount of tumor cells (high sensitivity), It has been shown to be compatible with cytological specimens, and its clinical usefulness has been announced in previous pilot studies. Traditional gene panel testing requires a tissue sample with sufficient tumor cell abundance compared to single-gene testing. We believe that the ability to perform companion diagnostics for mutations in the above-mentioned four genes in cases where only tissue specimens with a very small amount of tumor cells or cytological specimens can be obtained is a major advance. It is highly expected that the lung cancer compact panel will help further promote precision individualized medicine and improve treatment results as a test that responds to unmet medical needs in lung cancer diagnosis.
【the next deployment】
In the lung cancer area, molecularly targeted drugs are being launched one after another, and the number of types continues to increase, and the corresponding companion diagnostics are becoming more complex. Comprehensive companion diagnostics that include all drugs are desired, but there are still cases where multiple genetic tests are unavoidable because the drug groups corresponding to each test are different. Therefore, in the future, we will aim for an all-in-one comprehensive companion diagnostic for non-small cell lung cancer, and will add a test function for the three driver genes of BRAF, KRAS, and RET (7 genes in total) to this product. We are proceeding with development for insurance application.
We will continue to strive to contribute to the improvement of patient treatment outcomes and quality of life by responding to the needs of the medical field with cutting-edge genetic analysis technology. This has already been factored into the results for this fiscal year. Inspection overview
Brand name: Lung cancer compact panel (R) Dx multi-companion diagnostic system Generic name: Somatic gene mutation analysis program (for anticancer drug indication determination)
Approval number: 30400BZX00263000
Target country: Japan
Target specimen: Tissue (FFPE tissue, unfixed tissue or cytology) collected by surgery or biopsy from patients with non-small cell lung cancer
Target genes: EGFR, ALK, ROS1, MET
*For details, please check the attached document to be published. * Lung cancer compact panel test URL:
*1 Driver gene:
Genes that play a direct role in the development and progression of cancer. *2 Non-small cell lung cancer:
Lung cancer is roughly divided into non-small cell carcinoma and small cell carcinoma, with the former accounting for 85-90%.
Adenocarcinoma accounts for the majority of non-small cell lung cancer, and squamous cell carcinoma and large cell carcinoma are also included.
*3 Companion diagnosis:
A test that detects genetic mutations before administration to determine whether a specific drug (molecular-targeted drug) is effective.
For example, if an EGFR gene mutation is detected, a
molecular-targeted drug suitable for that gene mutation is
administered, and its therapeutic effect is expected.
*4 Next Generation Sequencing (NGS):
Advanced technology to determine the base sequence of nucleic acids and analyze genetic information. When performing mutation analysis of a specific gene, multiple samples can be tested at the same time with high sensitivity and high efficiency.
*5 Gene panel test:
A test that simultaneously detects multiple genetic mutations using next-generation sequencing technology.
Details about this release: