Seegene Launches KFDA-Approved COVID-19 Assay

Seegene Inc. (Seoul, South Korea) has received approval from the Korea Ministry of Food and Drug Safety for its novel coronavirus (COIVD-19) Real-time PCR assay for emergency use, following the recent obtaining of CE-IVD Mark. The company has begun offering the assays in Korea and across the world.

Seegene is a developer of multiplex molecular technologies and multiplex clinical molecular diagnostics (M-MoDx). Its core enabling technologies - DPO™, TOCE™, and MuDT™ - are the foundation for M-MoDx tests that can simultaneously detect multiple targets with high sensitivity, specificity and reproducibility.

Seegene had launched a single-tube assay, Allplex™ 2019-nCoV Assay that identifies the three different target genes (E gene, RdRP gene and Ngene) designed based on the international recommended protocols posted by World Health Organization (WHO). The capability of a simultaneous test in a single-tube, compared to the existing multi-tube assays, greatly improves the efficiency in workflow, maximizing the throughput for a high volume test and minimizing the test cost.

Seegene's automated system with its auto analysis software provides test results in four hours and can perform thousands of tests a day. When used together with Seegene's other high multiplex respiratory assay portfolio that screens and identifies 19 respiratory viruses and seven pneumonia bacteria with similar symptoms, it is able to diagnose the cause accurately and promptly. Seegene is capable of manufacturing 100,000 COVID-19 tests a day in order to meet the demands from the market and international society.

"It is meaningful that our molecular diagnostic technology and product can contribute to the international community in need of this new virus," said Dr. Jong-Yoon Chun, CEO and Founder of Seegene. "We are pleased to report KFDA approval of our COIVD-19 assay and are ready to support global healthcare organizations in need of our diagnostic solution."

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