H.U. Group Holdings Inc. and its wholly owned subsidiary Fujirebio today announced that Health Canada has issued Class II Medical Device Licenses (MDL) for the Lumipulse G NfL Blood and the Lumipulse G pTau 217 Plasma assay for use on the fully automated LUMIPULSE® G immunoassay platform in the Canadian market.

NanoSomiX, Inc., a biotechnology company focused on blood‑based analytics using extracellular vesicles (EVs), including brain‑derived EVs, today announced plans to collaborate with Beckman Coulter Diagnostics, a global leader in clinical diagnostics, to explore the development of next‑generation immunoassays for neurodegenerative diseases.

Not every assay needs the same substrate. But every assay needs the right one.

Bio-Rad Laboratories has obtained the CE mark for next-generation versions of its Specialty Immunoassay Plus quality control reagents, the firm said Wednesday.

Beckman Coulter Diagnostics, a Danaher company and a leader in global clinical diagnostics innovation, today launched the industry's first fully automated Brain-derived Tau (BD-Tau) research use only (RUO) immunoassay test. Access BD-Tau, along with Beckman Coulter Diagnostics' expanding portfolio of neurodegenerative disease RUO assays, is available for use on the groundbreaking DxI 9000 Immunoassay Analyzer and Access 2 Analyzer. This portfolio of assays enables precision medicine research on clinical-grade platforms for a variety of neurodegenerative diseases and includes p‑Tau217, NfL, GFAP and APOE ε4.

AliveDx said Tuesday that it has registered its multiplex immunoassay analyzer for autoimmune disease and allergy testing with the US Food and Drug Administration as a Class II device that is exempt from premarket authorization requirements.

QuidelOrtho Corporation (Nasdaq: QDEL) ("QuidelOrtho") and BÜHLMANN Laboratories AG today announced the availability of the BÜHLMANN fCAL turbo and fPELA turbo assays on QuidelOrtho's VITROS Systems as an MPA. Both particle-enhanced turbidimetric immunoassays, the fCAL turbo assay for fecal calprotectin measurement aids in the diagnosis of inflammatory bowel disease (IBD) and its differentiation from irritable bowel syndrome, and the fPELA turbo assay for fecal pancreatic elastase aids in the determination of pancreatic insufficiency.

The immunoassay segment accounts about 35% of the market, with no growth compared to the previous year. Domestic brands account for over 35%.

Tecan Group (SIX Swiss Exchange: TECN) today announced an agreement to acquire certain assets relating to key ELISA immunoassay products from Cisbio Bioassays SAS, a subsidiary of the global life sciences and diagnostics company, Revvity Inc. The asset purchase includes the manufacturing process of four ELISA kits – two in vitro diagnostic (IVD) products for specialty diagnostics and disease monitoring, and two research-use-only (RUO) kits.

Omics firm Sapient said Wednesday that it has partnered with Alamar Biosciences to provide proteomics services using Alamar's NULISA multiplexed immunoassay platform.