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 Premium 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. Jan 22, 2018 Korean MFDS Clears NGeneBio's Breast and Ovarian Cancer Test Sep 26, 2017 Korean MFDS Clears Gencurix Lung Cancer Test Jul 12, 2017 Altona Diagnostics Zika Test Approved for Korean Market Jul 11, 2017 After Securing CE-IVD for Debut Hereditary Cancer Dx, Korea's NGeneBio Readies NGS Tests for Launch Premium Jul 6, 2017 NGeneBio Garners CE-IVD Mark for NGS BRCA Test Apr 12, 2017 After Korean Clinical Approval for Breast Cancer Prognostic, Gencurix Looks to Asian, US Markets Premium Sep 9, 2016 Bioneer Gets Korean Approval for Zika Detection Kit Sep 2, 2016 Altona Zika Test Gets Emergency Use Authorization From Korean CDC Oct 10, 2014 CMS Finalizes NCD for Exact's Cologuard; Issues Preliminary Pricing in Line With Company Proposal Jul 6, 2012 HealthLinx Says New OvPlex Algorithm Beats CA125 in Avoiding False Positives Premium Oct 14, 2011 Is Healthlinx Eyeing Purchase of Correlogic's Assets as Part of Move into US Cancer Dx Market? Premium Breaking News CDC Provides $90M in Funding to Establish Pathogen Genomics Network People in the News at 23andMe, DNAnexus, Next Gen Diagnostics, More Study Finds Metabolomic States Informing Common Disease Risk New Products Posted to GenomeWeb: Allelica, Vizgen, Codex DNA, More In Brief This Week: Thermo Fisher Scientific, Exact Sciences, T2 Biosystems, Helix, More The Scan Mosquitos Genetically Modified to Prevent Malaria Spread A gene drive approach could be used to render mosquitos unable to spread malaria, researchers report in Science Advances. Gut Microbiomes Allow Bears to Grow to Similar Sizes Despite Differing Diets Researchers in Scientific Reports find that the makeup of brown bears' gut microbiomes allows them to reach similar sizes even when feasting on different foods. Finding Safe Harbor in the Human Genome In Genome Biology, researchers present a new approach to identify genomic safe harbors where transgenes can be expressed without affecting host cell function. New Data Point to Nuanced Relationship Between Major Depression, Bipolar Disorder Lund University researchers in JAMA Psychiatry uncover overlapping genetic liabilities for major depression and bipolar disorder.