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Qiagen, Centogene join forces on rare disease testing, 1/18

January 2018—Qiagen and Centogene announced a collaboration and comarketing agreement to provide customers more complete sample-to-insight research and clinical testing solutions in rare genetic diseases. The collaboration includes the integration of Centogene’s CentoMD rare disease variant database into Qiagen’s bioinformatics offering to enhance test interpretation.

Toxicologic Pathology call for papers, 1/18

January 2018—The Society of Toxicologic Pathology invites CAP members to consider a call for papers and contribute to the publication of a special 2019 issue focusing on medical devices in pathology in support of preclinical studies.

FDA approves CAR T therapy for specific B-cell lymphomas, 1/18

January 2018—Kite Pharma announced that the FDA has approved Yescarta (axicabtagene ciloleucel), a cell-based gene therapy, to treat adult patients with certain types of large B-cell lymphoma who have not responded to or who have relapsed after at least two other kinds of treatment.

Siemens closes on Epocal acquisition, 1/18

January 2018—Siemens Healthineers closed on the acquisition of Epocal from Abbott, on Oct. 31, to complete its blood gas portfolio.

Modular nucleic acid prep system, 1/18

January 2018—A modular automated liquid-handling and purification system developed by Promega for its Maxwell nucleic acid preparation is designed to allow laboratories of all sizes to adapt to changing workflows. The configurable system works with existing Promega Maxwell RSC instruments with a software upgrade and introduces two components, the Maxprep Liquid Handler and the Maxwell RSC 48.

NeoGenomics to host molecular symposium, 1/18

January 2018—NeoGenomics will host a molecular symposium titled “NGS for Clinicians and Pathologists: An Overview of Principles and Clinical Applications,” Feb. 23–24, at Laguna Cliffs Marriott Resort and Spa, Dana Point, Calif.

Chemiluminescent assay for HIT, 1/18

January 2018—Instrumentation Laboratory announced FDA 510(k) clearance of the HemosIL AcuStar HIT-IgG(PF4-H) Assay and HemosIL AcuStar HIT Controls. The assay is an on-demand, fully automated chemiluminescent reagent for use on hemostasis testing systems for the qualitative detection of platelet factor 4 (PF4)-heparin complex IgG antibodies associated with heparin-induced thrombocytopenia.

Expanded FDA approval for Cellvizio, 1/18

January 2018—Mauna Kea Technologies has received expanded FDA 510(k) clearance for the Cellvizio 100 series confocal laser microscope and its Confocal Miniprobes. The expanded clearance adds indications for identification of cells and vessels and their organization or architecture.

PCT assay for Beckman AU analyzers, 1/18

January 2018—EKF Diagnostics announced that its Stanbio Chemistry Procalcitonin LiquiColor assay has been FDA cleared and validated for use on Beckman Coulter AU480, 680, and 5800 clinical chemistry analyzers. EKF confirms the immediate availability of a user defined application for running this 10-minute test for bacterial infection and sepsis on these ­analyzers.

Hemlibra OK’d for hemophilia A with inhibitors, 1/18

January 2018—Genentech announced the FDA’s approval of Hemlibra (emicizumab-kxwh) for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adults and children with hemophilia A with factor VIII inhibitors.

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