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.

Roche (SIX: RO, ROG; OTCQX: RHHBY), in collaboration with KlinRisk, Inc., has received the CE-mark for the first AI-based risk stratification tool to assess progressive decline in kidney function. This milestone allows Roche to introduce the Chronic Kidney Disease (CKD) algorithm panel on its navify® Algorithm Suite to support care across all stages of the CKD care pathway. The panel includes the new Kidney Klinrisk Algorithm - for early risk assessment of adults diagnosed with CKD as well as adults with diabetes or hypertension at elevated risk for kidney function decline - alongside the established CE-marked Kidney KFRE Algorithm (KFRE) for managing later disease stages of CKD.

The routine four items are usually used for preoperative examination, but they cannot specifically determine the cause of thrombosis and bleeding in patients.

CareDx, Inc. (Nasdaq: CDNA) – The Transplant Company™ – a leading precision medicine company focused on the discovery, development, and commercialization of clinically differentiated, high-value healthcare solutions for transplant patients and caregivers – today announced new innovations and products that will be featured at The American Society for Histocompatibility and Immunogenetics (ASHI) 2025 Annual Meeting, held October 6th to 10th in Orlando, Florida. The company also announced that its AlloSeq® Tx and QTYPE® products have received certification for compliance to the In Vitro Diagnostic Regulation (IVDR) in the European Union.

Hologic, Inc. (Nasdaq: HOLX) announced today that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for the Panther Fusion® Gastrointestinal (GI) Bacterial and Expanded Bacterial Assays. The company also announced that the assays obtained CE marking in the European Union in accordance with In Vitro Diagnostic Regulation (IVDR). These highly sensitive molecular tests are designed to rapidly detect the most common bacterial pathogens responsible for infectious gastroenteritis.

Profitability among IVD companies diverged sharply. Mindray led with a net profit of RMB 5.069 billion in H1 2025, followed by Andon Health (RMB 920 million) and Snibe (RMB 771 million).

Sysmex and Qiagen's Japanese subsidiary said Tuesday that they have expanded their longstanding partnership to include the distribution of clinical diagnostic products for infectious diseases and cancer in Japan.

Revvity, Inc. (NYSE: RVTY) today announced a program for expansion of its type 1 diabetes (T1D) offering to include a population-scale assay for early detection with support from Sanofi (EURONEXT: SAN and NASDAQ: SNY). Revvity will develop a T1D 4-plex in vitro diagnostic (IVD) assay based on its existing research-use (RUO) 3-plex assay.

FUJIFILM Healthcare Americas Corporation, a leading provider of diagnostic and enterprise imaging solutions, and PRECIDX, a healthcare data optimization company, have partnered to integrate Fujifilm’s Synapse® Pathology solution with the PRECIDX Optimization Platform (POP) to reduce digital pathology file storage by an unprecedented 85%[1]contributing to lower storage costs for providers, improved workflow, and expanded access to critical data.

Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, today announced that the U.S. Food and Drug Administration (FDA) has approved its Guardant360® CDx as a companion diagnostic to identify advanced breast cancer patients with ESR1 mutations who may benefit from Eli Lilly and Company’s Inluriyo (imlunestrant). Guardant360 CDx was approved in conjunction with Inluriyo for the treatment of adults with estrogen receptor-positive (ER+), human epidermal growth factor receptor 2-negative (HER2–), ESR1-mutated advanced or metastatic breast cancer whose disease progressed after at least one line of endocrine therapy (ET).

Nineteen companies reported R&D-to-revenue ratios above 20% in H1 2025. Roughly 42.5% of IVD companies increased their R&D spending compared to revenue.