NEW YORK – Seegene has received emergency use approval from the Korea Ministry of Food and Drug Safety for an assay to detect the novel coronavirus 2019-nCoV, also known as SARS-CoV-2, which causes coronavirus disease 2019 (COVID-19). The real-time PCR-based test has also received CE-IVD mark and is now commercially available.
Seegene's test, called the Allplex 2019-nCoV Assay, is a single-tube assay that identifies three different target genes — E, RdRP, and N — based on the international recommended protocols provided by World Health Organization.
"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," Jong-Yoon Chun, CEO and founder of Seegene, said in a statement.
A simultaneous test in a single tube, compared to existing multi-tube assays, improves workflow efficiency and maximizes throughput for a high-volume test while minimizing test cost, according to Seegene.
The test runs using Seegene's automated system and analysis software, providing test results in four hours. The system also runs the firm's high multiplex respiratory assay portfolio that screens and identifies 19 respiratory viruses and seven pneumonia bacteria with similar symptoms to COVID-19.
Seegene has the capability to manufacture 100,000 COVID-19 tests per day, the firm said.