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China Approves the First Cerebrospinal Fluid Test Panel for Alzheimer¡¯s Disease
2025-12-17
Roche Diagnostics¡¯ Elecsys® Alzheimer¡¯s disease (AD) cerebrospinal fluid (CSF) test panel has received approval from the National Medical Products Administration (NMPA) for market launch in China. This marks the first in vitro diagnostic (IVD) product in China¡¯s neurology field to be granted Priority Review status, and it is currently the only CSF-based AD test panel approved for clinical diagnosis in the country.
Exact Sciences Provides First Look at MRD Test Performance in Triple-Negative Breast Cancer
2025-12-17
Exact Sciences is building evidence on the ability of its Oncodetect minimal residual disease (MRD) test to determine the risk of distant recurrence in breast cancer patients in the hopes of expanding its adoption and reimbursement in this setting.
Helio Genomics, Telemedicine Firm LiverRight Partner on Liver Cancer Dx
2025-12-17
Helio Genomics said Monday that it has partnered to offer its LiverTrace at-home blood test for liver cancer in partnership with liver health telemedicine firm LiverRight.
IVD China last week: DIAN, Sansure, AmoyDx, Zybio
2025-12-16
DIAN Diagnostics¡¯ In-House R&D Solid Tumor Large Panel Receives Full Marks in EMQN EQA The European Molecular Genetics Quality Network (EMQN) released the results of its ONCOGENE PANEL external quality asse..
Lunit, Daiichi Sankyo Partner to Support Biomarker Discovery for Two Oncology Programs
2025-12-16
Lunit on Monday said it has started a collaboration with Daiichi Sankyo to use its artificial intelligence-based digital pathology tools to advance translational research and biomarker discovery for two of Daiichi's oncology pipeline programs.
FDA Expands Labels For Roche's HER2 CDx Assays to ID Breast Cancer Patients Eligible For Enhertu
2025-12-16
Roche said Monday that the US Food and Drug Administration has approved the company's Pathway anti-HER2/neu (4B5) Rabbit Monoclonal Primary Antibody and Ventana HER2 Dual ISH DNA Probe Cocktail tests, clearing them for identifying HER2-positive metastatic breast cancer (mBC) patients who may be eligible for treatment with AstraZeneca's Enhertu (trastuzumab deruxtecan).
Natera, MEDSIR to Collaborate on MiRaDoR Breast Cancer Trial
2025-12-15
Natera said Friday that it is collaborating with oncology research firm Medica Scientia Innovation Research (MEDSIR) on the MiRaDoR breast cancer trial for hormone receptor-positive, HER2-negative breast cancer.
Inotiv, Vugene Partner on AI-Driven Drug Discovery Using Multiomics Data
2025-12-15
Original from: genomeweb Contract research organization Inotiv said Thursday that it has partnered with Lithuanian multiomics data analysis firm Vugene on artificial intelligence-assisted drug discovery...
Statistical Communiqu¨¦ of the People's Republic of China on the 2024 National Medical and Healthcare Development
2025-12-15
I. Health Resources 1. Total Number of Medical and Health Institutions By the end of 2024, the total number of medical and health institutions nationwide reached 1,093,551, an increase of 22,766 compared t..
TrilliumBio, Oncobit Partner to Offer Uveal Melanoma Monitoring Test in the US
2025-12-12
Diagnostics firm TrilliumBio said Tuesday that it is collaborating with Oncobit to offer the Swiss company's uveal melanoma monitoring assay in the US.
Amplifold Raises €5M to Commercialize DNA Origami Diagnostics
2025-12-12
German diagnostic startup Amplifold said Wednesday that it has raised €5 million ($5.8 million) in an oversubscribed seed financing round.
Roche Nabs CE Mark for PCR-Based Vaginitis Assay
2025-12-10
Roche announced Tuesday that its PCR-based test for vaginitis has received CE marking. The test is now available in countries accepting the designation.
BillionToOne Q3 Revenues More Than Double Year Over Year
2025-12-10
Molecular diagnostics firm BillionToOne reported after the close of the market on Tuesday that its Q3 2025 revenues more than doubled year over year.
In Vitro Diagnostic Industry in China - Diagnosis of Blood and Body Fluids XVII
2025-12-09
3.4 Assembly Line Trend With the in-depth study of the hemostasis and thrombosis, the hemostasis and coagulation testing has become increasingly important. With the increasingly abundant coagulation test items, ..
Pillar Biosciences, AstraZeneca Expand Partnership on Liquid Biopsy Cancer Testing to China
2025-12-09
Pillar Biosciences and AstraZeneca said Monday that they are expanding their collaboration on liquid biopsy testing to include China.
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