The KFDA approved Seegene’s COIVD-19 real-time PCR assay following the recent CE-IVD mark approval
Render of 2019-nCoV virion (Credit: CDC/ Alissa Eckert, MS; Dan Higgins, MAM)
Seegene has secured approval from the Korea Ministry of Food and Drug Safety (KFDA) for its coronavirus (COIVD-19) real-time PCR assay for the emergency use.
The approval follows the recent CE-IVD mark for the assay.
Allplex 2019-nCoV assay detects three different target genes
Allplex 2019-nCoV assay, a single-tube assay, holds the capacity to detect three different target genes such as E gene, RdRP gene and Ngene.
The genes have been designed as per the international recommended protocols revealed by the World Health Organisation (WHO).
Compared to the existing multi-tube assays, the simultaneous test in a single-tube enhances the efficiency in workflow and maximise the throughput for a high volume test, as well as minimise the test cost.
The company’s automated system with its auto analysis software Seegene viewer is more useful in an epidemic situation where thousands of tests need to perform in a day. The test results will be available within four hours.
The assay, when used along with the company’s other high multiplex respiratory assay portfolio, will help diagnose the cause precisely and quickly.
Seegene’s multiplex respiratory assay portfolio will help screen and detect 19 respiratory viruses and seven pneumonia bacteria with similar symptoms.
The company holds the capacity to produce 100,000 COVID-19 tests per day to meet the demands from the market and international society.
Seegene founder and CEO Dr Jong-Yoon Chun said: “It is meaningful that our molecular diagnostic technology and product can contribute to the international community in need of this new virus.
“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.”
Seegene is engaged in the development of multiplex molecular technologies and multiplex clinical molecular diagnostics (M-MoDx).
Recently, Public Health England (PHE) launched the novel coronavirus diagnostic test in the UK to better deal with the virus that causes serious respiratory illness.