Bioneer approves change of manufacturing license for 'COVID-19 and flu simultaneous diagnosis kit'

Bioneer announced on the 9th that it had recently applied for a manufacturing license change for the ‘AccuPower® RV1 Multiplex Kit’, a simultaneous diagnosis kit for COVID-19 and flu, from the Ministry of Food and Drug Safety to extend the validity period of the diagnostic reagent.
This change application was a preemptive decision of Bioneer to prepare for the situation after COVID-19 amid the growing importance of in vitro diagnostic medical devices due to COVID-19. As the extension of the validity period of diagnostic reagents was approved, unopened reagents increased from 12 months to 18 months, and opened reagents increased from 8 months to 12 months, respectively. Product safety and distribution efficiency are improved. This made it possible to respond more quickly to the simultaneous diagnosis demand of major domestic and foreign countries.
Bioneer’s ‘AccuPower® RV1 Multiplex Kit’ is a product with patented technology that can diagnose with only 5 copies of Corona 19 virus RNA per 1 μl of nucleic acid such as human or virus extracted from nasal and oropharyngeal swabs. can be diagnosed at the same time.
A Bioneer official said, “As expectations for COVID-19’s endemic transition are growing around the world, demand for kits that can test for COVID-19 and flu simultaneously is also increasing. At the same time, considering the expansion of global supply, we will gradually extend the validity period of the diagnostic reagent to two years or more.”
[이 상 규 매경닷컴 기자][ⓒ 매일경제 & mk.co.kr, 무단전재 및 재배포 금지]