Presently, the domestic IVD market shows a slow overall growth rate, but with the emergence of new projects, the improvement of industry concentration, and the emergence of assembly line trends, etc., the blood coagulation market will become thriving.
Stay up-to-date with the latest happenings in the rapidly evolving field of In Vitro Diagnostics (IVD) in China.
Thermo Fisher Scientific, the world leader in serving science, has received approval from the U.S. Food and Drug Administration (FDA) for its Oncomine Dx Target Test as a companion diagnostic (CDx) to identify patients who may be candidates for HERNEXEOS® (zongertinib tablets), a tyrosine kinase inhibitor (TKI), developed by Boehringer Ingelheim. The test allows clinicians and pathologists to assess if non-small cell lung cancer (NSCLC) tumors harbor human epidermal growth factor receptor 2 (HER2/ERBB2) tyrosine kinase domain (TKD) activating mutations.
Abbott (NYSE: ABT) and Exact Sciences (NASDAQ: EXAS) today announced a definitive agreement for Abbott to acquire Exact Sciences, which will enable it to enter and lead in fast-growing cancer diagnostics segments, serving millions more people. Under the terms of the agreement, Exact Sciences shareholders will receive $105 per common share, representing a total equity value of approximately $21 billion.
Sapphiros today announced a strategic supply and manufacturing option agreement with Roche that will grant exclusive rights to lateral flow technology manufacturing capacity to at least 1 billion tests annually from Sapphiros' extreme volume manufacturing process installed in the UK. The reel-to-reel manufacturing capability of Sapphiros can produce up to 5 billion diagnostics per year.
Abbott Laboratories is nearing a potential acquisition of cancer screening company Exact Sciences Corp., people familiar with the matter said, in what could be the biggest deal of the year in the global health-care sector.
Lunit, a leading provider of AI for cancer diagnostics and precision oncology, and Labcorp, a global leader of innovative and comprehensive laboratory services, today announced a collaborative initiative to accelerate innovation in digital pathology (DP) and artificial intelligence (AI) for oncology research and clinical care.
BD (Becton, Dickinson and Company) (NYSE: BDX), a leading global medical technology company, today announced that the Conformité Européenne (CE) Marked BD Onclarity™ HPV Assay for the BD COR™ System and the BD Viper™ LT System have been accepted for the World Health Organization (WHO) list of prequalified in vitro diagnostic products, further expanding access to high-quality cervical cancer screening tools in low- and middle-income countries.
The U.S. Food and Drug Administration (FDA) has approved the Promega OncoMate® MSI Dx Analysis System as a companion diagnostic designed to identify patients with microsatellite stable (MSS; defined as not MSI-high [not MSI-H]) endometrial carcinoma who may benefit from treatment with KEYTRUDA® (pembrolizumab), Merck’s anti-PD-1 therapy, plus LENVIMA® (lenvatinib), the orally available multiple receptor tyrosine kinase inhibitor discovered by Eisai. This is the first Promega companion diagnostic to receive FDA approval.
MDxHealth SA (NASDAQ: MDXH) (the “Company” or “mdxhealth”), a leading precision diagnostics company, today announced its financial results for the three and nine-month period ended September 30, 2025.
SOPHiA GENETICS (NASDAQ: SOPH), a global leader in AI-driven precision medicine, and Element Biosciences, Inc., a biology company transforming the pace and accessibility of scientific discovery, today announced at the Association for Molecular Pathology (AMP) Annual Meeting a partnership that unites sequencing and AI analytics to streamline genomic workflows and accelerate the research supporting precision medicine.
Merck (NYSE: MRK), known as MSD outside of the United States and Canada, and Cidara Therapeutics, Inc. (Nasdaq: CDTX) (“Cidara”), a biotechnology company developing drug-Fc conjugate (DFC) therapeutics, today announced that the companies have entered into a definitive agreement under which Merck, through a subsidiary, will acquire Cidara for $221.50 per share in cash, for a total transaction value of approximately $9.2 billion.
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