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 FDA Revises SARS-CoV-2 Test Emergency Use Authorization Requirements to Account for Variants Geisinger Wins $5M NIH Grant to Develop Point-of-Care Genetic Diagnostic Tool Second Genome, Virginia Commonwealth University Partner on NASH Biomarker Discovery LGC Receives CE Mark for AccuPlex SARS-CoV-2, Flu A/B, RSV Reference Material Kit Esophageal Cancer Testing Firm Lucid Diagnostics Files For IPO Twist Bioscience, DeepCDR Collaborate on Antibody Library Design The Scan Booster for At-Risk The New York Times reports that the US Food and Drug Administration has authorized a third dose of the Pfizer-BioNTech SARS-CoV-2 vaccine for people over 65 or at increased risk. Preprints OK to Mention Again Nature News reports the Australian Research Council has changed its new policy and now allows preprints to be cited in grant applications. Hundreds of Millions More to Share The US plans to purchase and donate 500 million additional SARS-CoV-2 vaccine doses, according to the Washington Post. Nature Papers Examine Molecular Program Differences Influencing Neural Cells, Population History of Polynesia In Nature this week: changes in molecular program during embryonic development leads to different neural cell types, and more.