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Seegene has received approval from the South Korea Ministry of Food and Drug Safety for its novel coronavirus (Covid-19) Real-time PCR assay for emergency use.
The assay recently received the CE Mark.
The firm will immediately begin supplying the assays in South Korea and across the globe.
Due to global concern over the rapid spread of Covid-19, the market is demanding a more accurate diagnostic solution to cut down the prevalence of the coronavirus, according to the company.
Seegene introduced a single-tube assay, Allplex 2019-nCoV Assay, which can detect three different target genes, E gene, RdRP gene and Ngene.
The assay has been designed based on the international recommended protocols posted by World Health Organization (WHO).
Due to the feasibility of a simultaneous test in a single-tube as against the existing multi-tube assays, it becomes possible to improve the efficiency in workflow, maximise the throughput for a high volume test and reduce the test cost, claimed Seegene.
The firm’s automated system, with its auto analysis software Seegene viewer, is useful in an epidemic situation, where thousands of tests may be carried out in a day, providing test results in four hours.
Furthermore, when used along with the firm’s other high multiplex respiratory assay portfolio, it becomes possible to accurately diagnose, stated the company.
Seegene can manufacture 100,000 Covid-19 tests a day to meet the growing demand.
Seegene CEO and founder 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 Covid-19 assay and are ready to support global healthcare organizations in need of our diagnostic solution.”