Skip to main content
Premium Trial:

Request an Annual Quote

FDA Issues Emergency Use Authorization for Seegene Coronavirus PCR Assay

NEW YORK – South Korean molecular diagnostics firm Seegene announced after the close of the market on Tuesday that the US Food and Drug Administration has granted Emergency Use Authorization for the firm's Allplex 2019-nCoV Assay, a real-time RT-PCR test for the SARS-CoV-2 coronavirus.

Seoul-based Seegene said in a statement that the test, which is CE-marked, and was previously authorized by Canadian regulators, and received emergency use approval in South Korea for use against the coronavirus, can identify three different target genes – the E, RdRP, and N genes – in one reaction tube, allowing for highly accurate results and maximizing the throughput for high-volume testing.

The firm added that it has sold more than 10 million of the Allplex 2019-nCoV Assay in more than 60 countries.

"Our automated system, with its advanced analysis software, has proven to be extremely useful due to its convenience and scalability, especially in such a pandemic situation where thousands of tests may be required to be performed in a day at every location," Seegene CEO Jong-Yoon Chun said in the statement.

The Scan

Suicidal Ideation-Linked Loci Identified Using Million Veteran Program Data

Researchers in PLOS Genetics identify risk variants within and across ancestry groups with a genome-wide association study involving veterans with or without a history of suicidal ideation.

Algorithm Teases Out Genetic Ancestry in Individuals at Biobank Scale

Researchers develop an algorithm known as Rye to tease apart ancestry fractions in admixed individuals at a biobank-scale, applying it to 488,221 UK Biobank participants in Nucleic Acids Research.

Multi-Ancestry Analysis Highlights Comparable Common Variants at Complex Trait-Linked Loci

Researchers in Nature Genetics examine common variants implicated in more than three dozen conditions, estimating genetic effect similarities across ancestry tracts in admixed individuals.

Sick Newborns Selected for WGS With Automated Pipeline

Researchers successfully prioritized infants with potential Mendelian conditions for whole-genome sequencing or rapid whole-genome sequencing, as they report in Genome Medicine.