KYORIN Pharmaceutical Co., Ltd.
Acquisition of Manufacturing and Marketing Approval for Influenza Virus Nucleic Acid Kit “GeneSoC® FluA/B Detection Kit”
Manufacturing and marketing approval obtained from the Ministry of Health, Labour and Welfare for the Influenza Virus Nucleic Acid Kit "GeneSoC FluA/B Detection Kit," scheduled for sales launch in the first half of fiscal 2026.
Key Figures
- Date of manufacturing and marketing approval: 2026-02-04
- Scheduled sales launch: First half of fiscal 2026
- Detection time: Approximately 15 minutes
AI要約
Product Overview and Features
Kyorin Pharmaceutical Co., Ltd. has obtained manufacturing and marketing approval as an in vitro diagnostic medical device from the Ministry of Health, Labour and Welfare for the Influenza Virus Nucleic Acid Kit "GeneSoC FluA/B Detection Kit." Sales are planned to commence in the first half of fiscal 2026. This product enables differentiation and detection of influenza A and B viruses in approximately 15 minutes using the genetic analysis devices "GeneSoC mini 2" and "GeneSoC mini." Compared to conventional products, it achieves improved detection sensitivity and reduced measurement time.
Future Outlook and Impact on Performance
This product is expected to contribute to the rapid diagnosis of influenza and will strengthen the company’s contribution to the diagnosis, prevention, and treatment of infectious diseases by promoting the development and launch of GeneSoC-specific in vitro diagnostic medical devices and research reagents for respiratory infections and other conditions. The impact on the earnings guidance for the fiscal year ending March 2026 due to this matter is considered minimal.
