Mindray blood cell analysis research and development team launched this product based on stable, accurate and reliable quality.

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

Abbott (NYSE: ABT), a global healthcare leader, announced today it has secured CE Mark for the world's first dual glucose‑ketone sensing technology for people with diabetes. Branded as Libre Duo and Libre Duo 10 Day, the systems are designed to continuously measure glucose and ketone levels every minute, providing real-time visibility into both glucose levels needed for daily diabetes management as well as rising ketones that can lead to a diabetic ketoacidosis (DKA) emergency. This marks the first time people with diabetes will be able to monitor ketones without traditional blood or urine tests. Abbott plans to begin launching Libre Duo systems in select European countries later this year.

Roche (SIX: RO, ROP; OTCQX: RHHBY) announced today the launch of its comprehensive Liver Disease Panel, a suite of certified algorithms designed to help clinicians better identify and manage chronic liver disease (CLD). By bringing together biomarker-based diagnostics and advanced digital algorithms, including the CE-marked algorithm LiverPRO, the Liver Disease Panel supports better-informed clinical decisions, from timely fibrosis risk identification, to the surveillance of liver cancer.

TOBY, Inc., a biotechnology company developing non-invasive disease detection technologies, today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation to the TOBY Test for Alzheimer's Disease. The designation recognizes the test's potential to aid in the diagnosis of Alzheimer's disease through a simple, non-invasive urine sample and address a major unmet need in accessible cognitive evaluation and diagnostic care.

Trend of domestic blood typing reagent patent applications can be seen from Fig. 3, number of domestic Blood typing reagent-related patent applications increased rapidly between 2014 and 2017, which reached the peak of 38 applications for the whole year of 2017.

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.