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

By the end of 2024, the total number of medical and health institutions nationwide reached 1,093,551, an increase of 22,766 compared to the previous year.

A workgroup convened by the Alzheimer’s Association has published revised criteria for the diagnosis and staging of Alzheimer’s disease that are based on the biology of the disease and reflect recent advancements in Alzheimer’s research, diagnostics and treatment. The 2024 update includes an updated biomarker classification system that includes blood-based biomarkers (BBM) and a revised disease staging system.

Cepheid announced today that it has received FDA De Novo marketing authorization and Clinical Laboratory Improvement Amendments (CLIA) Waiver approval for Xpert® HCV, the only molecular test in the US to detect hepatitis C virus RNA directly from a human capillary whole blood (fingerstick) sample. The Xpert HCV test is performed on the GeneXpert Xpress System.

Illumina (ILMN.O), opens new tab said on Thursday it will take a goodwill impairment charge of $1.47 billion in the second quarter related to recently spun-off cancer diagnostic test maker Grail (GRAL.O)

Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the World Health Organization (WHO) has awarded the cobas® HPV test prequalification designations for use on the cobas® 5800 system and for self-collected samples on the cobas® 5800, 6800 and 8800 systems. These new prequalification designations come just one month after the U.S. Food and Drug Administration approved Roche’s HPV self-collection solution and less than a year after the WHO awarded prequalification to the cobas HPV test on the cobas 6800/8800 systems.

AmoyDx, a China-based innovative molecular diagnostics company, and Servier, an independent international pharmaceutical group, announced today they have entered into a strategic partnership to develop a companion diagnostic test (CDx) in China that detects Isocitrate Dehydrogenase (IDH) 1&2 gene mutations. This test will be developed for vorasidenib, Servier’s investigational dual inhibitor of mutant IDH1 and mutant IDH2 enzymes, for Chinese patients with diffuse IDH-mutant glioma (LGG).

Quest Diagnostics (NYSE: DGX), a leading provider of diagnostic information services, and Allina Health, a leading, non-profit health care system, today announced a definitive agreement for Quest to acquire select laboratory assets from Allina Health, with the goal to improve access to and the affordability of innovative laboratory services across Minnesota and western Wisconsin.

bioMérieux, a world leader in the field of in vitro diagnostics, today announces that its BIOFIRE® SPOTFIRE® Respiratory/Sore Throat (R/ST) Panel Mini has received U.S. Food and Drug Administration (FDA) Special 510(k) clearance and CLIA-waiver (Clinical Laboratory Improvement Amendments).

Olink is integrating its automated Explore HT high-throughput proteomics workflows with SPT Labtech's Firefly liquid handling platform, the companies said on Tuesday.

As companies developed with biochemical reagents, BSBE, Leadman, Medicalsystem, Maccura, Dirui, and Zybio are still flourishing in the biochemistry field; they are also developing new products and expanding into other areas based on the biochemical diagnosis while maintaining the existing biochemical product lines.

Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today the launch of its new analytical units, cobas® c 703 and cobas® ISE neo, for the cobas® pro integrated solutions, in countries accepting the CE mark. The cobas pro integrated solutions is a scalable and modular diagnostic platform designed for high-volume laboratories. The cobas c 703 and cobas ISE neo analytical units offer cutting-edge features to help address some of the key challenges faced by diagnostic laboratories worldwide such as shortage of qualified staff and space limitations.