DiaSorin on Thursday said it has submitted for US Food and Drug Administration approval an immunoassay for the early identification of Lyme disease.

Roche announced on Tuesday that it has received CE marking for a claim extension on its Elecsys Anti-Müllerian Hormone (AMH) Plus test.

The immunoassay method involves the widest range of items among all fields of medical detection; with the development of biomedical research, especially genomics and post-genomics results (high-resolution two-dimensional electrophoresis combined with mass spectrometry) which highly promote the research on disease-related markers, more and more items will be detected via immunoassay in the medical practice.

Rapid test maker Hangzhou Clongene Biotech and diagnostics product distributor Gold Colloid on Friday said they inked a deal to distribute Clongene's in vitro­ diagnostics products in the US.

Chemiluminescence immunoassay reagent has become the mainstream product in the field of immunoassay and is widely used in clinical in vitro diagnosis due to its advantages such as high sensitivity, good specificity, a wide range of measurements, high degree of supporting automation, and excellent precision and accuracy.

There are multiple classification criteria for immunodiagnostic techniques, the most commonly used of which are classified into labeled immunoassays and non-labeled immunoassays according to whether they are labeled or not.

By rapid development of China's immunoassay, the market share of chemiluminescence has gradually expanded. Immunoassay diagnosis was already the largest sub-field of the market in China, currently accounting for about 25%.

H.U. Group Holdings Inc. and its wholly-owned subsidiary Fujirebio today announced the availability of the Lumipulse G pTau 217 Plasma assay for the fully automated LUMIPULSE G immunoassay systems. This CLEIA (chemiluminescent enzyme immunoassay) assay allows for the quantitative measurement of Tau phosphorylated at threonine 217 (pTau 217) in human K2EDTA plasma within just 35 minutes.

The immunoassay market has been the main driven force for the development of the in vitro diagnostics industry in recent years.

Fujirebio Holdings, Inc. (President & CEO: Goki Ishikawa) and Sysmex Corporation (President: Kaoru Asano) today announced that they have signed an agreement for the mutual supply of reagent raw materials owned by both companies (“the Agreement”). The Agreement is based on a basic agreement on business collaboration in the field of immunoassay*1 which the two companies signed in October 2023.