[Photo provided by Seegene]
Kosdaq-listed Seegene, a South Korean point-of-care diagnostic company, said on Thursday it has completed a pre-submission meeting with the U.S. Food and Drug Administration, a preliminary step to export the company’s coronavirus sampling kit to the United States.
Welcoming the news, shares of Seegene soared 13.51 percent to close at 67,200 won on Thursday, outperforming the secondary Kosdaq market that plunged 11.71 percent to 428.35 on the same day.
A pre-sub is a voluntary process for the submitter when the FDA’s feedback on specific questions is necessary to guide product development and/or submission. Once FDA okays Seegene’s new coronavirus testing kit after its review, the Korean company would be able to export the kit to the U.S.
Seegene already received a nod from the Ministry of Food and Drug Safety in Korea to market its COIVD-19 real-time PCR kit dubbed Allplex 2019-nCoV Assay for the emergency use.
The company is also in talks for shipping the kit to European countries after obtaining a CE-IVD mark for the assay.
The single-tube assay holds the capacity to detect three different target genes (E, RdRP, N) at the same time, completing a detection test in four hours versus six hours of the existing multi-tube assays.
[ⓒ Pulse by Maeil Business Newspaper & mk.co.kr, All rights reserved]