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.
QIAGEN announced today the expansion of its digital PCR (dPCR) offering for the development of cell and gene therapies in the biopharma industry.
Molecular diagnosis refers to the technique of using molecular biological methods to detect changes in the structure or expression level of genetic material in patients to make a diagnosis.
Devyser’s novel test for detecting donor-derived cell-free DNA in blood samples from kidney-transplant patients and its product for screening and follow-up of stem cell transplant patients fulfill IVDR requirements in Europe.
Beckman Coulter Diagnostics, a clinical diagnostics leader, and Fujirebio, a leader in neurological markers and In Vitro Diagnostic (IVD) manufacturing, today announced a new partnership combining their respective immunoassay strengths to support therapeutic development, clinical trials, reimbursement, and routine clinical adoption in the field of neurodegenerative diseases.
On the evening of July 12, Zhejiang Orient Gene Biotech Co., Ltd announced that its wholly owned subsidiary, Shanghai Wanzi Health Medical Laboratory Co., Ltd., had obtained medical device registration certificates for carcinoembryonic antigen, neuron-specific enolase, and cytokeratin 19 fragment detection kit (flow fluorescence luminescence method).
A partnership between Quest Diagnostics and Envision Sciences has introduced a new prostate cancer biomarker test.
To address challenges with error-prone, manual molecular testing workflows, Thermo Fisher Scientific today has introduced Diomni Enterprise Software, helping streamline routine diagnostics testing for standardization and faster time-to-results. By connecting workflow steps within one interface, Diomni Enterprise can increase a lab’s ability to dynamically respond to today’s rapidly changing testing environment. The solution can be used by a variety of labs performing routine quantitative polymerase chain reaction (qPCR) diagnostic tests and by developers to increase the speed of innovation for emerging testing solutions.
Recently, Ustar and Hangzhou Biotest Biotech received the IVDR CE certificate from TÜV SÜD, a notified body designated under the EU's IVDR.
Fortis Life Sciences on Wednesday said it has acquired diagnostic testing component maker International Point of Care.
Tempus, a leader in artificial intelligence and precision medicine, announces its GEMINI Non-small Cell Lung Cancer (NSCLC) study (NCT05236114). The Tempus-sponsored study, being run in collaboration with AstraZeneca, aims to create a robust multi-omic dataset for patients with NSCLC to facilitate future novel research related to precision medicine, diagnostic development, and biomarker discovery.
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