Thermo Fisher Scientific, the world leader in serving science, today announced the U.S. Food and Drug Administration (FDA) has approved the Oncomine™ Dx Express Test on the Ion Torrent™ Genexus™ Dx Integrated Sequencer as an in vitro diagnostic (IVD) assay for use as a companion diagnostic (CDx) for Dizal’s ZEGFROVY® (sunvozertinib) and in tumor profiling. This approval brings rapid next-generation sequencing (NGS) to decentralized clinical settings closer to where patients receive care. With the ability to deliver essential genomic insights in as little as 24 hours*, this approval helps advance the accessibility of precision oncology tools and enables more timely decision making.

The TOBY Test has received breakthrough device designation from the FDA for the early detection of bladder cancer. This designation underscores the significant potential of this innovative urine-based assay to fundamentally alter the landscape of bladder cancer detection and surveillance, offering a much-needed non-invasive alternative to current diagnostic paradigms.

Merck, a leading science and technology company, today announced that it has closed the acquisition of SpringWorks Therapeutics, Inc., for an enterprise value of $3.4 billion (approximately €3 billion)*, following regulatory clearances and the fulfillment of other customary closing conditions.

Molecular diagnosis is performed at the gene level with nucleic acids as the object for detection, with high sensitivity and accuracy.

Stay up-to-date with the latest happenings in the rapidly evolving field of In Vitro Diagnostics (IVD) in China.

PathAI, a global leader in artificial intelligence (AI) and digital pathology solutions, today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for AISight® Dx*—its digital pathology image management system—for use in primary diagnosis in clinical settings. Building on the initial 510(k) clearance for AISight Dx(Novo) in 2022, this latest milestone underscores the platform’s continuous innovation and PathAI’s commitment to delivering enhanced capabilities as the product evolves.

Microsoft has built an artificial intelligence-powered medical tool it claims is four times more successful than human doctors at diagnosing complex ailments, as the tech giant unveils research it believes could speed up treatment.

MGI Tech Co., Ltd. (MGI), a company dedicated to developing core tools and technologies that drive innovation in life sciences, today announced a partnership with Negedia, an initiative born from Fondazione Telethon to expand access to DNBSEQ™-powered genomic sequencing and Stereo-seq spatial transcriptomics for precision medicine and biomedical research in Italy.

RetinalGenix Technologies Inc. OTCQB:RTGN (“RetinalGenix” or the “Company”), a pioneering developmental-stage company focused on ophthalmic screening, monitoring, pharmacogenetic mapping, and repurposed drug development for early detection and treatment of eye and systemic diseases, has entered into an agreement with LabCorp, one of the nation’s largest laboratory services organizations, to support the rollout of the RetinalGenix DNA/RNA/GPS Pharmaco-Genetic Mapping™ platform. This innovative program enables patients to undergo genetic testing and high-resolution retinal imaging anonymously and provide insights into both ocular and systemic diseases.

Sysmex America, Inc., a leading diagnostic solutions company offering hematology, hemostasis, urinalysis, flow cytometry and informatic solutions, has received FDA clearance for the CN-6000™ Automated Blood Coagulation Analyzer. This clearance includes the reagent products used in five commonly performed hemostasis tests: