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

PureLab, part of PureHealth, has signed a Memorandum of Understanding (MoU) with Baynounah Gene Solutions to explore opportunities for collaboration across diagnostics innovation, synthetic biology, molecular sciences, and research and development initiatives in the UAE.

Seegene, a global molecular diagnostics company, announced the European launch of its new antimicrobial resistance (AMR) testing product, Allplex™ MDRO Assay, which is CE marked under the EU In Vitro Diagnostic Regulation (IVDR). The assay is designed to support the detection of multidrug-resistant organisms (MDROs) associated with healthcare-associated infections (HAIs).

Foundation Medicine, Inc., a global, patient-focused precision medicine company, today announced that it has received approval from the U.S. Food and Drug Administration (FDA) for FoundationOne®CDx to be used as a companion diagnostic (CDx) for TEPMETKO® (tepotinib) developed by EMD Serono, the healthcare business of Merck KGaA, Darmstadt, Germany in the U.S. and Canada. TEPMETKO received accelerated approval from the FDA in February 2021 and traditional approval in February 2024 for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) harboring mesenchymal-epithelial transition (MET) exon 14 skipping alterations (METex14).

Diasorin (FTSE MIB: DIA) announced today that it has received 510(k) clearance from the US Food and Drug Administration (FDA) for the LIAISON PLEX Gastrointestinal Flex Assay, a fully customizable syndromic testing panel capable of detecting a market-leading 24 gastrointestinal pathogen targets. The new panel expands Diasorin’s growing LIAISON PLEX assay portfolio, which also includes a customizable respiratory assay and three blood culture panels.

Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, today announced that the U.S. Food and Drug Administration (FDA) has approved Guardant360® Liquid CDx, advancing blood-based comprehensive genomic testing by integrating genomic and epigenomic insights and helping clinicians make better-informed treatment selection decisions for patients with advanced cancer. Guardant360 Liquid CDx is the largest FDA-approved liquid biopsy panel, assessing a 100X wider genomic footprint than the previously approved Guardant360 CDx to deliver comprehensive tumor profiling results. The seven previously U.S. FDA-approved companion diagnostic indications for Guardant360 CDx transfer to the new test with the FDA approval of Guardant360 Liquid CDx.

QIAGEN (NYSE: QGEN; Frankfurt Prime Standard: QIA) announced at the 2026 BIO-IT World Conference & Expo in Boston that the QIAGEN Digital Insights bioinformatics business and its curated knowledge bases and bioinformatics expertise will be integrating NVIDIA accelerated computing and the NVIDIA BioNeMo platform to help researchers use AI more effectively in drug discovery.

At present, domestic blood typing reagent-related products already covered ABO blood typing, test of Rh and other irregular antibodies, and anti-human globulin test.

AstraZeneca and Roche Diagnostics Asia Pacific today announced a three-year Memorandum of Understanding to help advance digital pathology capabilities and elevate cancer care across nine Asia markets, a first in the region. This landmark collaboration aims to accelerate the adoption of AI-powered digital and computational pathology through educational and training initiatives and improve biomarker testing in breast and lung cancer.

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