Close Menu

South Korean FDA

The Korean company's test qualitatively detects the Orf1a and N genes of the novel coronavirus in specimens from patients with suspected respiratory infection.

The assay, which uses the Bioneer ExiStation molecular diagnostics instrument, was also recently registered for purchase by the Global Fund.

The companion diagnostic for Pfizer's Xalkori identifies 14 ROS1 gene fusions by analyzing tumor messenger RNA from human tumor tissue or body fluids.

The workflow was cleared by the South Korean Ministry of Food and Drug Safety for the typing of HLA-A, B, C, DRB1, and DQB1 by next-generation sequencing.

The Seoul-based company also recently raised $1.9 million in series B funding and is targeting between $7 million and $8 million to close the round.

NGeneBio said this week that its next-generation sequencing panel has been approved as an IVD, the first NGS test to be cleared in Korea.

Gencurix's assay can be used to select which non-small cell lung cancer patients will respond to tyrosine kinase inhibitors.

The assay is based on real-time reverse transcriptase PCR that will identify Zika in human serum or urine. 

NGeneBio is moving ahead with plans to have the test cleared for diagnostic use in Korea, while envisioning a 2019 submission to the US FDA.

The Korean molecular diagnostics startup is planning to launch the new offering in Europe, as well as China and other Southeast Asian countries.

Pages

President Donald Trump might not approve the stricter standards the US Food and Drug Administration is developing for authorizing a SARS-CoV-2 vaccine, according to Politico.

Wired reports that Oxitec has now developed a genetically modified fall armyworm.

A large genetic study finds SARS-CoV-2 viruses with a certain variant are spreading more than others, according to the Washington Post.

In Nature this week: sister-chromatid-sensitive chromosome conformation capture approach, and more.