Announcement of the Manufacturing and Sales Approval for “Lung Cancer Compact Panel Dx Multiplex Companion Diagnostic System” (Medical Device Program)
November 17, 2022
On November 16, 2022, DNA Chip Research, Inc. (President and Representative Director: Ryo Matoba) announced that the company has received specially-controlled medical device manufacturing and sales approval for a “Lung Cancer Compact Panel Dx Multiplex Companion Diagnostic System” (hereinafter, Lung Cancer Compact Panel). We have been working on the development of a highly sensitive multiple genetic test that specializes in key genes (driver genes*1) for lung cancer. With this manufacturing and sales approval for the Lung Cancer Compact Panel, the device can be used as a companion diagnostic test,*2 especially for patients with non-small cell lung cancer,*3 to detect mutations in four representative driver genes and determine the suitability of drugs to treat them. This product was developed based on the research results from the Nara Institute of Science and Technology and the Osaka International Cancer Institute.