WellsBio Obtains US FDA Approval for COVID-19 Diagnostic Kit Export and Completes European Certification

[Asia Economy Reporter Eunmo Koo] Wells Bio, a subsidiary of Access Bio, announced on the 10th that it had obtained export approval from the Ministry of Food and Drug Safety (MFDS) on the 8th for the careGENETM COVID-19 RT-PCR Kit, a diagnostic kit for the novel coronavirus infection (COVID-19).

Wells Bio had already acquired the European certification (CE) for the diagnostic kit on the 31st of last month. The careGENETM COVID-19 RT-PCR Kit, which received export approval this time, is a molecular diagnostic kit that simultaneously detects the N gene and RdRp gene of COVID-19 in a single tube, which is the method mainly used by the U.S. Centers for Disease Control and Prevention (CDC).

The COVID-19 diagnostic genes generally include the RdRp gene, E gene, and N gene. The World Health Organization (WHO) guidelines recommend detecting the E gene and RdRp gene, while the U.S. Food and Drug Administration (FDA) recommends diagnosis using the N gene.

Wells Bio had already developed the “careGENETM N-CoV RT-PCR Kit,” a molecular diagnostic kit that detects both the Pan-coronavirus E gene and the COVID-19 specific RdRp gene in accordance with WHO guidelines, and quickly obtained export approval on the 26th of last month.

A Wells Bio official stated, “With the new export approval and European certification of the careGENETM COVID-19 RT-PCR Kit product, we have established a lineup that can meet various demands worldwide.”

Wells Bio is a subsidiary of Access Bio, whose shares were acquired by Wooridul Pharmaceutical in July last year. Wooridul Pharmaceutical has signed overseas supply licensing agreements for Wells Bio’s careGENETM N-CoV RT-PCR Kit and careGENETM COVID-19 RT-PCR Kit.

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