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South Korean FDA

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.

Gencurix aims to achieve US FDA 510(k) clearance for its GenesWell BCT breast cancer prognostic test next year.

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The American Prospect writes that the pilot program to test the DNA of migrants could lead to more family separations.

An international commission is to develop a report on how researchers, clinicians, and regulators should evaluate the clinical applications of human germline genome editing.

The US Department of Agriculture presents a new blueprint for animal genomic research.

In Genome Research this week: repetitive element deletion linked to altered methylation and more in form of muscular dystrophy; human contamination in draft bacterial and archaeal genomes; and more.