Implementation of in Vitro Diagnosis of Thrombosis and Hemostasis in the Chinese Market

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

Qiagen is partnering with Oxford Gene Technology, a Sysmex subsidiary, to comarket and distribute its Qiagen Clinical Insight (QCI) Interpret software with OGT's SureSeq NGS panels, the firms announced Thursday. Financial terms were not disclosed.

Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the U.S. Food and Drug Administration (FDA) has categorized its Ionify® 25-Hydroxy Vitamin D total assay as “Moderate Complexity” under the Clinical Laboratory Improvement Amendments of 1988 (CLIA). This represents the first time a mass spectrometry-based test has achieved this designation, opening access to a broader range of clinical laboratories.

The Life Science division of Meridian Bioscience, Inc., a leading global provider of diagnostic testing solutions and life science raw materials, today announced the launch of the industry's first liquid qPCR master mixes proven stable for over 12 months at ambient temperatures and shippable with oligos without compromising performance. This breakthrough eliminates the need for refrigeration, freezing, or costly lyophilization (freeze-drying), offering a level of flexibility and convenience not previously available in liquid formats. With superior performance, these new mixes expand Meridian's portfolio of ambient-stable molecular reagents while simplifying logistics, reducing costs, and delivering sustainable solutions for assay developers and high-throughput automation users across all settings — from point-of-care (POC) to centralized labs.

Biocartis Group of Companies (“Biocartis”), an innovative molecular diagnostics company, is pleased to announce that its Idylla™ CDx MSI Test developed in partnership with Bristol Myers Squibb, has received the first-ever Premarket Approval (PMA) from the FDA for a cartridge-based, fully automated, “sample-to-result” companion diagnostic test.

Roche (SIX: RO, ROG; OTCQX: RHHBY) shared real-world evidence from the rollout of Accu-Chek SmartGuide continuous glucose monitoring (CGM) solution at the European Association for the Study of Diabetes (EASD) annual meeting today, and announced its integration with the mySugr diabetes management app, providing many more people with diabetes access to an AI-enabled predictive solution for the first time.

Digital pathology firm Proscia announced on Tuesday that it has expanded its collaboration with Amazon Web Services by integrating Proscia's Concentriq pathology platform with AWS HealthImaging, a service for storing and sharing whole-slide images in the cloud.

China has been engaged in the R&D and manufacturing of semi-automatic coagulation analyzers for over a decade, and based on the data from the website of the NMPA, in 2024 and 2025 (as od 15 August), a total of 2 instruments from 2 manufacturers have obtained registration certificates...

Renalytix plc (LSE: RENX) (OTCQB: RNLXY), today announced an agreement with Tempus AI, Inc. (NASDAQ: TEM) to make kidneyintelX.dkd prognostic blood testing more widely available for eligible patients within its US network of healthcare institutions. Eligible patients have type 2 diabetes with chronic kidney disease, impacting nearly 15 million individuals in the US.

Labcorp (NYSE: LH), a global leader of innovative and comprehensive laboratory services, and OPKO Health, Inc. (Nasdaq: OPK), a multinational biopharmaceutical and diagnostics company, announced today the completion of Labcorp's acquisition of select assets of BioReference Health, a wholly owned subsidiary of OPKO Health.

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