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

New research has uncovered protein signatures associated with different forms of Alzheimer's disease (AD), including markers found in plasma, cerebrospinal fluid (CSF), and brain tissue.

Recently, the Tianjin Medical Products Administration issued the "Notice on the Demonstration and Promotion of the Unique Identification of Medical Devices".

The US Food and Drug Administration (FDA) has granted approval for Lumos Diagnostics’ FebriDx rapid point-of-care (POC) test.

Today, in collaboration with single cell genomics company, Honeycomb Biotechnologies (“Honeycomb”), Revvity (NYSE: RVTY) announced the launch of a suite of new solutions and services that expand the frontiers of single cell biology: the HIVE™ CLX Single-Cell RNAseq Solution, BeeNetPLUS analysis workflow, and for single cell researchers based in the United States, a new HIVE CLX Service offering.

In recent years, the market scale of immunodiagnostic reagents in China has been increasing year by year. In 2020, the market size of China's immunodiagnostic reagent industry reached 32.1 billion yuan, an increase of 24.42% year-on-year.

Renalytix has received De Novo marketing authorisation from the US Food and Drug Administration (FDA) for its KidneyIntelX.dkd prognostic test.

Houston-based single-cell analysis company CellChorus announced on Wednesday that it has been awarded a $2.2 million Small Business Innovation Research (SBIR) Fast-Track grant from the National Institute of General Medical Sciences (NIGMS).

On June 29, Merck announced an investment of approximately 70 million euros to expand its Nantong Life Science Center in the heart of the Yangtze River Delta region.

LumiraDx Limited (Nasdaq: LMDX), a leading innovator in diagnostic technologies, today announced the submission of its first 510(k) application to the U.S. Food and Drug Administration (FDA) for the clearance of its ground-breaking 5-minute COVID Ultra Test. LumiraDx submitted a traditional 510(k) Dual Submission for LumiraDx SARS-CoV-2 Ag Ultra with CLIA Waiver for the commercial distribution at point of care of the LumiraDx Platform, including the LumiraDx Instrument, with the LumiraDx SARS-CoV-2 Antigen (Ag) Ultra test, and the LumiraDx SARS-CoV-2 Ag Quality Control Swab Kit.

Helio Genomics said Thursday that its sister company, Laboratory for Advanced Medicine & Health Group (LAMH), has received approval from the National Medical Products Administration (NMPA) in China for its cell-free DNA-based liver cancer detection test. The assay is the first of its kind to receive this approval.