Different medical institutions have selected different imported and domestic brand instruments: 38 domestic and 58 imported.

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

Taiwanese cancer genomics firm ACT Genomics (ACTG) and Japanese clinical testing service provider LSI Medience said Monday that they have signed a memorandum of understanding to advance personalized medicine in Japan.

Roche subsidiary Foundation Medicine said Monday that the US Food and Drug Administration has approved its liquid biopsy test, FoundationOne Liquid CDx, as a companion diagnostic to identify advanced BRCA-mutated prostate cancer patients who are eligible for treatment with Janssen's Akeega (niraparib and abiraterone acetate).

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

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).