To ensure the quality and safety of medical services in primary healthcare institutions, China’s National Health Commission (NHC) and other relevant authorities issued a notice on 1 April 2026, outlining a three-year nationwide action.
Microplate-based automatic blood grouping analyzer Metis of Aikang MedTech Co., Ltd. (henceforth referred to as Aikang) received approval for marketing in 2015; and its MGT-based automatic blood grouping analyzer Aigel received approval for marketing in 2016.
Burning Rock Biotech Limited (NASDAQ: 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 ended March 31, 2025.
Fujirebio, a leading innovator in in-vitro diagnostics, today announced a collaboration with Stanford Medicine (Location: Palo Alto, California, USA) to advance research and innovation in the field of infectious disease testing. This collaboration aims to accelerate the adoption of ultrasensitive immunoassays that incorporate single-molecule counting technology developed by Fujirebio’s Silicon Valley wholly-owned subsidiary, Fluxus, Inc. Greater test sensitivity can better inform treatment decisions in the clinic, as well as accelerate studies towards therapeutics and preventive strategies against infectious disease threats worldwide.
Randox Laboratories announced that the U.S. Food and Drug Administration (FDA) has approved the De Novo application for the company’s first Companion Diagnostic (CDx). This is a major achievement for Randox following over 3 years of innovative development and collaboration with Novo Nordisk. The Companion Diagnostic was developed as a new option for determining the amount of medication a patient with hemophilia has received.
Cepheid today announced that Health Canada has issued Cepheid a medical device licence for Xpert® HIV-1 Viral Load XC, a next-generation extended-coverage (XC) test intended to aid in assessing HIV viral load levels, which are used to monitor effectiveness of antiretroviral treatment.
China's drug regulator has approved the country's first domestically developed 9-valent human papillomavirus (HPV) vaccine, ending over a decade of foreign dominance in the market.
Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, today announced that its Shield multi-cancer detection (MCD) test has been granted Breakthrough Device designation from the U.S. Food and Drug Administration (FDA). The Shield MCD test is a methylation-based blood test for the multi-cancer screening of multiple cancer types including bladder, colorectal, esophageal, gastric, liver, lung, ovarian and pancreas cancer in individuals aged 45 or older who are at typical average risk for cancer.
QuidelOrtho Corporation (Nasdaq: QDEL) (the "Company" or “QuidelOrtho”), a global provider of innovative in vitro diagnostic technologies designed for point-of-care settings, clinical labs and transfusion medicine, today announced a refocusing of its molecular diagnostics strategy. This strategy includes the intent to acquire full ownership of LEX Diagnostics after 510(k) clearance by the U.S. Food and Drug Administration ("FDA") for consideration at closing of approximately $100 million and plans to discontinue the Company's Savanna platform development.
POCT technology has gradually evolved from classical immunochromatography to more sensitive platforms hosting multiple detection technologies, such as luminescence and molecular detection.
PathAI, a leading provider of AI-powered pathology solutions, and Northwestern Medicine, Chicago’s premier integrated academic health system, today announced a strategic collaboration to transform pathology diagnostics through artificial intelligence. This multi-year collaboration will see Northwestern Medicine implement PathAI’s AISight digital pathology image management system with the goal of driving efficiency and quality in pathology operations. In addition to the digital innovation efforts, this joint effort establishes a broad framework for joint research initiatives, clinical innovation programs, and co-development of new AI-powered diagnostic tools aimed at improving patient outcomes.
QIAGEN (NYSE: QGEN; Frankfurt Prime Standard: QIA) today announced the expansion of its oncology diagnostics portfolio with two strategic partnerships to advance the use of minimal residual disease (MRD) testing in clinical trials to support pharma co-development projects for companion diagnostics. The new collaborations with Tracer Biotechnologies and Foresight Diagnostics expand QIAGEN’s reach in MRD testing and cover solid tumors and hematological cancers.
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