South Korean FDA
Solgent Coronavirus Test Gets CE Mark, EUA from Korean, Philippines Authorities
The Korean company's test qualitatively detects the Orf1a and N genes of the novel coronavirus in specimens from patients with suspected respiratory infection.
Bioneer HIV-1 Dx Kit Gets Korea FDA Approval
The assay, which uses the Bioneer ExiStation molecular diagnostics instrument, was also recently registered for purchase by the Global Fund.
AmoyDx Lung Cancer CDx Approved in South Korea
The companion diagnostic for Pfizer's Xalkori identifies 14 ROS1 gene fusions by analyzing tumor messenger RNA from human tumor tissue or body fluids.
GenDx Gets South Korean Clearance for HLA Typing Workflow
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.
Building on BRCA Test Launch, NGeneBio Rolls Out NGS Panels for Solid Tumors, Hematological Cancers
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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.