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In Vitro Diagnostic Industry in China - Blood Typing Instruments and Reagents II
2026-02-10
2. Blood Typing Instruments and Reagents Blood typing-related products mainly include two sectors of blood typing instruments and blood typing reagents. 2.1 Blood Typing Instruments Accompani..
Hologic Receives FDA Approval for Aptima® HPV Assay Primary Screening Option, Expanding Cervical Health Portfolio
2026-02-09
Hologic, Inc. (Nasdaq: HOLX) announced today that its Aptima® HPV Assay received FDA approval for clinician-collected HPV primary screening. Hologic’s human papillomavirus (HPV) test is the only FDA-approved mRNA-based assay, designed specifically to detect infections most likely to lead to cervical cancer.
Fujirebio and Sysmex begin sales collaboration for dementia testing
2026-02-09
Fujirebio Holdings, Inc. (HQ: Minato-ku, Tokyo; President & CEO: Goki Ishikawa; “Fujirebio”), a consolidated subsidiary of H.U. Group Holdings, Inc. (HQ: Minato-ku, Tokyo; Chairman, President and Group CEO: Shigekazu Takeuchi) and Sysmex Corporation (HQ: Kobe, Japan; President: Kaoru Asano, “Sysmex”) have agreed on a sales collaboration for dementia testing. This agreement follows continued discussions based on the Basic Agreement on Business Collaboration in the Field of Immunoassay concluded in October 2023.
Diasorin Has Been Granted De Novo Authorization in the U.S. for the First Fully Automated Laboratory Test for Hepatitis Delta Virus (HDV) on the Liaison XL
2026-01-30
Diasorin (FTSE MIB: DIA) announced today it has secured U.S. Food and Drug Administration (FDA) De Novo authorization for the first fully automated diagnostic test for hepatitis delta virus (HDV) on the Diasorin LIAISON XL immunoassay system. Designated as a Breakthrough Device by the FDA, the test aids in the diagnosis of HDV in individuals living with acute and chronic hepatitis B virus (HBV). The development of the automated diagnostic assay has been supported by Gilead Sciences.
Thermo Fisher Scientific Reports Fourth Quarter and Full Year 2025 Results
2026-01-30
Thermo Fisher Scientific Inc. (NYSE: TMO), the world leader in serving science, today reported its financial results for the fourth quarter and full year ended December 31, 2025.
Roche reports strong 2025 results with 7% sales growth
2026-01-29
Original from: Roche - Group sales grew by 7%1 at constant exchange rates (CER; 2% in CHF), driven by strong demand for medicines and diagnostic solutions. - Sales in the fourth quarter increased b..
Danaher Reports Fourth Quarter and Full Year 2025 Results
2026-01-29
Original from: Danaher Danaher Corporation (NYSE: DHR) (the "Company") today announced results for the fourth quarter and full year 2025. All results in this release reflect only continuing operations a..
BD Announces Record Date for the Spin-Off of its Biosciences & Diagnostic Solutions Business
2026-01-28
BD (Becton, Dickinson and Company) (NYSE: BDX) ("BD" or the "Company") today announced that the Company's Board of Directors has set the close of business on February 5, 2026, as the record date for the previously announced spin-off of BD's Biosciences & Diagnostic Solutions business to BD's shareholders. Immediately following the spin-off, the spun-off entity will be combined with Waters Corporation (NYSE: WAT) ("Waters") in a Reverse Morris Trust transaction. The combination is expected to be completed on February 9, 2026, subject to the satisfaction of customary closing conditions.
In Vitro Diagnostic Industry in China - Diagnosis of Blood and Body Fluids XXIV
2026-01-27
The instruments employed by hospitals participating in the basic study were mainly from various manufacturers such as Sysmex, Stago, Werfen, Sekisui, Beckman, Mindray, Succeeder, BSBE, and Rayto, involving 96 instrume..
Chinese IVD Companies Assist in Nipah Virus Detection
2026-01-27
Recently, an outbreak of Nipah virus occurred in West Bengal, India, with 5 confirmed cases reported, including several healthcare workers. Nearly 100 people have been placed under home quarantine, and one patient is ..
Chinese university unveils humanoid diagnostic robot with non-invasive BCI tech to revolutionize early autism intervention
2026-01-27
The Fujian Agriculture and Forestry University in East China has unveiled the country's first humanoid diagnostic and treatment robot that deeply integrates non-invasive brain computer interface (BCI) technology. The robot is expected to help address long-standing challenges in early intervention of autism and other neurodevelopmental disorders, bringing good hope to the rehabilitation of more than 13 million autism patients in China, Global Times learned from the robot developers on Sunday.
DIASORIN Signs Exclusive Distribution Agreement for the Liaison Nes® Molecular Point-of-Care Platform and the Flu A/B, Rsv & Covid-19 Panel
2026-01-27
Diasorin (FTSE MIB: DIA) announced today that, following the recent 510(k) clearance and CLIA-waiver from the U.S. Food and Drug Administration (FDA) for its first assay—the FLU A/B, RSV & COVID-19 Panel for use on the LIAISON NES® platform— the Company has entered into an exclusive distribution agreement with Fisher Scientific, part of Thermo Fisher Scientific, for the LIAISON NES® molecular point-of-care (POC) platform in the U.S. hospital market.
Qure.ai Wins Gates Foundation Grant to Develop AI Point-of-Care Ultrasound for TB and Pneumonia Detection
2026-01-26
Qure.ai, a global digital health company focused on AI-led medical diagnostics, has received a multi-million-dollar grant from the Gates Foundation to support the development of AI-enabled point-of-care ultrasound and create an open-source multi-modal health database aimed at improving lung disease detection in underserved regions.
Merck no longer in talks to buy Revolution Medicines, WSJ reports
2026-01-26
Merck (MRK.N), opens new tab is no longer in discussions to buy cancer drug developer Revolution Medicines (RVMD.O), opens new tab, the Wall Street Journal reported on Sunday.
Guardant Health Receives FDA Approval for Guardant360® CDx as Companion Diagnostic for BRAFTOVI® (encorafenib) Combination in Patients with BRAF V600E-Mutant Metastatic Colorectal Cancer
2026-01-23
Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, today announced that the U.S. Food and Drug Administration (FDA) has approved Guardant360® CDx as a companion diagnostic to identify patients with BRAF V600E-mutant metastatic colorectal cancer (mCRC) who may benefit from treatment with BRAFTOVI® (encorafenib) in combination with cetuximab and chemotherapy in accordance with the approved product labeling.
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