Microplate-based automatic blood grouping analyzer Metis of Aikang MedTech Co., Ltd. (henceforth referred to as Aikang) received approval for marketing in 2015; and its MGT-based automatic blood grouping analyzer Aigel received approval for marketing in 2016.

Themed "Global IVD Innovation & Cross-Regional Integration," this groundbreaking event brings together distinguished experts from around the world to explore the future of diagnostics.

Lunit (KRX:328130.KQ), a leading provider of AI for cancer diagnostics and therapeutics, and Agilent Technologies Inc. (NYSE: A), a global leader in life sciences, diagnostics, and applied chemical markets, today announced a nonexclusive collaboration to develop AI-based companion diagnostic solutions. The collaboration will leverage Lunit's AI technology and Agilent's expertise in tissue-based companion diagnostics to create advanced solutions that meet the demand of novel and complex biomarker assays in drug development.

Revvity, Inc. (NYSE: RVTY) announced a strategic collaboration with Profluent, bringing together a range of its novel AI-engineered enzymes with Revvity’s established Pin-pointTM base editing platform. The result is simplified access for customers to a therapeutically relevant base editing toolkit.

Thrombotic diseases, in particular cardiovascular and cerebrovascular thrombotic diseases, have become the top cause of death in the population of China, and their incidence has increased, seriously endangering human health.

Diasorin (FTSE MIB: DIA) today announces the launch of the new LIAISON® TSH-R Ab assay, available in all countries recognizing the CE Mark. This assay is specifically developed to aid in the diagnosis and monitoring of patients with suspected Graves’ Disease, an autoimmune disorder characterized by autoantibodies, TSH-Receptor antibodies (TSH-R Ab), that can stimulate thyroid receptors, leading to increased production and release of hormones by the gland.

The Food and Drug Administration has rescinded its final rule on laboratory developed tests, formally ending a decades-long effort to expand oversight of the lab industry.

Qiagen is partnering with Oxford Gene Technology, a Sysmex subsidiary, to comarket and distribute its Qiagen Clinical Insight (QCI) Interpret software with OGT's SureSeq NGS panels, the firms announced Thursday. Financial terms were not disclosed.

Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the U.S. Food and Drug Administration (FDA) has categorized its Ionify® 25-Hydroxy Vitamin D total assay as “Moderate Complexity” under the Clinical Laboratory Improvement Amendments of 1988 (CLIA). This represents the first time a mass spectrometry-based test has achieved this designation, opening access to a broader range of clinical laboratories.

The Life Science division of Meridian Bioscience, Inc., a leading global provider of diagnostic testing solutions and life science raw materials, today announced the launch of the industry's first liquid qPCR master mixes proven stable for over 12 months at ambient temperatures and shippable with oligos without compromising performance. This breakthrough eliminates the need for refrigeration, freezing, or costly lyophilization (freeze-drying), offering a level of flexibility and convenience not previously available in liquid formats. With superior performance, these new mixes expand Meridian's portfolio of ambient-stable molecular reagents while simplifying logistics, reducing costs, and delivering sustainable solutions for assay developers and high-throughput automation users across all settings — from point-of-care (POC) to centralized labs.

Biocartis Group of Companies (“Biocartis”), an innovative molecular diagnostics company, is pleased to announce that its Idylla™ CDx MSI Test developed in partnership with Bristol Myers Squibb, has received the first-ever Premarket Approval (PMA) from the FDA for a cartridge-based, fully automated, “sample-to-result” companion diagnostic test.

Roche (SIX: RO, ROG; OTCQX: RHHBY) shared real-world evidence from the rollout of Accu-Chek SmartGuide continuous glucose monitoring (CGM) solution at the European Association for the Study of Diabetes (EASD) annual meeting today, and announced its integration with the mySugr diabetes management app, providing many more people with diabetes access to an AI-enabled predictive solution for the first time.