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Transcenta Holding Limited ("Transcenta") (HKEX: 06628), a clinical stage biopharmaceutical company with fully-integrated capabilities in discovery, research, development and manufacturing of antibody-based therapeutics, and Agilent Technologies, announce a collaboration to develop a Claudin18.2 (CLDN18.2) companion diagnostic to support TranStar301 global Phase III pivotal trial of Osemitamab (TST001) in combination with Nivolumab and chemotherapy as first-line treatment in patients with CLDN18.2 expressing locally advanced or metastatic gastric or gastroesophageal (G/GEJ) adenocarcinoma.2024-04-10View More
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BBI Solutions OEM Limited (BBI), the premier independent manufacturer of immunodiagnostic reagents globally, has announced the successful closing of the acquisition of IBEX Technologies Inc. (IBEX), a leading developer and manufacturer of high-precision enzymes and diagnostic solutions located in Montreal, Quebec. This acquisition strategically enhances BBI¡¯s capabilities to support In Vitro Diagnostic (IVD) manufacturers with the growing global demand for IVD haemostasis testing, driven by an ageing population, the rising prevalence of chronic diseases, and an increased reliance on point-of-care tests in surgery and trauma settings. By incorporating IBEX¡¯s innovative enzyme technologies into its extensive portfolio of recombinant proteins, BBI is also responding to the notable industry shift towards recombinantly produced reagents for IVD tests, reflecting a growing preference for more standardized and reliable testing methodologies.2024-04-10View More
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Building on 80 years of expertise engineering cold storage lab equipment, Thermo Fisher Scientific today introduces its newest line of high performance, ultra-low temperature (ULT) freezers. With enhancements to performance, user experience and energy efficiency, the Thermo Scientific™ TSX™ Universal Series ULT Freezers seamlessly adapt to scientists¡¯ workflows across a variety of lab settings, marking a new era in performance, reliability, and sustainability.2024-04-09View More
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Bio-Rad Laboratories, Inc. (NYSE: BIO and BIO.B) a global leader of life science research and clinical diagnostics products, today announces a collaboration with Allegheny Health Network (AHN), a western Pennsylvania¨Cbased integrated healthcare system. This research collaboration aims to generate clinical evidence across a range of cancer types to support the implementation of Bio-Rad¡¯s Droplet Digital™ PCR (ddPCR™) technology for tumor-informed molecular residual disease (MRD) monitoring of patients with solid tumor cancer following curative-intent treatment.2024-04-09View More
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Sebia, a global specialty diagnostic company providing innovative solutions for screening and diagnostics in oncology, metabolic diseases, genetic disorders and autoimmune diseases, today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for CAPILLARYS 3 DBS devices.2024-04-08View More
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Sysmex Corporation (HQ: Kobe, Japan; President: Kaoru Asano) and Siemens Healthcare Diagnostics Inc. (HQ: NY, U.S.A.) (¡°Siemens Healthineers¡±) announce that from April 2024, the companies have begun to distribute independently their combined portfolio of hemostasis testing solutions to laboratories in the United States and EU countries* under the companies¡¯ respective brands based on a mutual OEM supply initiative. This distribution is based on a global OEM agreement on hemostasis products concluded in February 2023 (hereinafter, "Agreement"). Moving forward, we will gradually expand the implementation of sales through this initiative on a global scale.2024-04-03View More
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QuidelOrtho Corporation (Nasdaq: QDEL) (¡°QuidelOrtho" or the ¡°Company¡±) has received U.S. Food and Drug Administration (¡°FDA¡±) 510(k) clearance for its QuickVue COVID-19 test. This clearance allows the test to be used with accuracy and convenience in home and medical facility settings with CLIA certificates of waiver. This achievement also reflects QuidelOrtho¡¯s dedication to delivering effective testing solutions while highlighting ongoing efforts in research and development to enhance market competitiveness.2024-04-03View More
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Agilent Technologies Inc. (NYSE: A) today announced the launch of the Advanced Dilution System, the ADS 2, a new automation workflow solution that will increase productivity, lower cost of ownership, and improve the overall efficiency within the laboratory.2024-04-02View More
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Abbott's i-STAT TBI cartridge has received clearance from the U.S. Food and Drug Administration (FDA) to be used with whole blood, allowing doctors to help assess patients with suspected concussion at the patient's bedside and obtain lab-quality results in 15 minutes. Previously, the tests to help with the assessment of TBI were only cleared for use with plasma or serum, requiring samples to be sent to a lab for processing and testing.2024-04-02View More
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Oxford Nanopore Technologies has signed a partnership with artificial intelligence developer SeqOne to support its next-generation sequencing approach in clinical diagnostic testing.2024-04-01View More
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Labcorp (NYSE: LH), a global leader of innovative and comprehensive laboratory services, and OPKO Health, Inc. (Nasdaq: OPK), a multinational biopharmaceutical and diagnostics company, announced today that they have entered into an agreement for Labcorp to acquire select assets of BioReference Health, a wholly owned subsidiary of OPKO Health.2024-04-01View More
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Genetron Holdings Limited (¡°Genetron Health¡± or the ¡°Company¡±, Nasdaq: GTH), a leading precision oncology platform company in China that specializes in offering molecular profiling tests, early cancer screening products and companion diagnostics development, announced today the completion of its merger (the ¡°Merger¡±) with Genetron New Co Limited (¡°Merger Sub¡±), pursuant to the previously announced agreement and plan of merger, dated as of October 11, 2023 (the ¡°Merger Agreement¡±), among the Company, New Genetron Holding Limited (¡°Parent¡±) and Merger Sub. As a result of the Merger, the Company has become a wholly owned subsidiary of Parent and will cease to be a publicly traded company.2024-03-29View More
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Burning Rock Biotech Limited (NASDAQ: BNR and LSE: BNR, the ¡°Company¡± or ¡°Burning Rock¡±), a company focused on the application of next generation sequencing (NGS) technology in the field of precision oncology, today reported financial results for the three months and the year ended December 31, 2023.2024-03-29View More
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French diagnostics firm BioM¨¦rieux said Wednesday that it has received 510(k) clearance from the US Food and Drug Administration for its BioFire SpotFire Respiratory/Sore Throat (R/ST) test panel.2024-03-28View More
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Bio-Techne announced on Friday that its subsidiary Asuragen has received certification under Europe's In Vitro Diagnostic Regulation for its test to monitor chronic myeloid leukemia patients.2024-03-27View More
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Illumina may avoid an approximately 432 million euro fine related to its Grail takeover after an adviser to the Court of Justice of the European Union (ECJ) ruled in its favor Thursday.2024-03-27View More
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QIAGEN (NYSE: QGEN; Frankfurt Prime Standard: QIA) today announced the release of the QIAstat-Dx Analyzer 2.0, including the Software 1.6 upgrade, a significant enhancement to the widely-used QIAstat-Dx Analyzer 1.0 for reliable, fast and cost-effective diagnosis of complex syndromes.2024-03-26View More
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The US Food and Drug Administration announced last week that Roche's Cobas Malaria test has been approved by the agency.2024-03-26View More
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Thermo Fisher Scientific said Wednesday that it has partnered with Bayer to develop companion diagnostic assays for the drugmaker¡¯s precision cancer therapies.2024-03-25View More
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The World Health Organization has published updated guidelines for the rapid diagnosis of tuberculosis, including new recommendations on the use of targeted next-generation sequencing (NGS) tests for drug-resistant TB.2024-03-25View More
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