Bioneer : Other Management Information(Voluntary Disclosure)

Other Management Information(Voluntary Disclosure)

1. Title	KFDA approval on domestic manufacturing of Tsutsugamushi (scrub typhus) diagnostic kits
2. Details	1. Approved by Ministry of Food and Drug Safety 2. Usage In vitro diagnostic medical device that detects the Tsutsugamushi bacteria genes in K2-EDTA-treated whole blood samples of patients who suspect a possible infection with the RT-PCR(Real-time polymerase chain reaction) detection method. 3. Classification IVD reagents for infectious disease marker 4. Product Name IRON-qPCR™ Tsutsugamushi Real-Time PCR Kit (TSU-1123) 5. Product License No. In-vitro license No. 22-262 6. Product Development Background Current antibody tests have challeanges such as low sensitivity, high false positivity, difficulty in early diagnosis, and distinguishing between past/current infections. With RT-PCR(Real-time polymerase chain reaction) detection method, rapid and accurate early diagnosis is possible. 7. Expected outcomes and strategic plan The corresponding kit is used with our product IRON-qPCR™. The company plans to develop various infectious disease diagnostic kits using the same platform and equipment, such as respiratory diseases and multidrug-resistant virus infection kits.
3. Decision(Confirmation) Date	2022-04-25
4. Other references concerning investment decisions
- The decision (confirmation) date above is the date of the Ministry of Food and Drug Safety delivered an official letter of amended approval to export in-vitro diagnostic medical devices.
※ Title and date of other disclosure related to this one	2022-04-25 Other Management Information(Voluntary Disclosure)(식약처, 쯔쯔가무시 진단키트 국내 제조허가)