Bioneer Receives MFDS Export Approval for 'Saliva and Pooled Testing' COVID-19 Diagnostic Kit

Compatible with Bioneer Equipment and US Thermo Fisher and Bio-Rad

[Asia Economy Reporter Kim Daehyun] Bioneer announced on the 31st that it has obtained export modification approval from the Ministry of Food and Drug Safety (MFDS) for the COVID-19 diagnostic kit 'AccuPower® SARS-CoV-2 Multiplex Real-Time RT-PCR Kit' (SCVM-2112, 2132, 2142).

This product allows for a simple saliva test to check for COVID-19 infection. Compared to the conventional nasopharyngeal and oropharyngeal swab collection methods that involve inserting a swab into the nose and mouth, it enables a more comfortable PCR test. Using this product for nasopharyngeal and oropharyngeal testing allows for pooling up to five specimens at once, enabling rapid confirmation of infection status. It has also previously obtained the European Union in vitro diagnostic medical device certification (CE-IVD) modification approval.

Bioneer expects that with the recent MFDS export modification approval, the product will be officially recognized in the European Union market for its capability of saliva PCR testing and pooled testing, placing it in a favorable position from a marketing perspective. Additionally, it anticipates that this product will help address workforce shortages and contribute to overcoming the spread of COVID-19 through proactive measures.

A Bioneer representative stated, "Clinical trials at medical institutions have fully demonstrated the excellent performance and convenient usage of the product, with results perfectly matching those of existing nasopharyngeal and oropharyngeal swab diagnostic kits," adding, "We will continue to supply total molecular diagnostic solutions for various other diseases overseas and maintain strong performance in the second half of the year."

This content was produced with the assistance of AI translation services.