Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the United States Food and Drug Administration (FDA) has cleared its Elecsys pTau181 test, the only blood-based biomarker (BBM) test indicated as an aid in the initial assessment for Alzheimer¡¯s disease and other causes of cognitive decline in the primary-care setting. The Elecsys pTau181 test is intended for patients ages 55 and older presenting with signs, symptoms or complaints of cognitive decline. It measures phosphorylated Tau (pTau) 181 protein in human plasma, a key biomarker for Alzheimer¡¯s pathology, including amyloid plaque and tau aggregate pathology.

Private equity group Warburg Pincus is nearing a deal to take a large minority stake in French diagnostics group Sebia, which values the business at €5.4bn, according to people familiar with the matter.

Roche announced its strategic collaboration with the Office for Attracting Strategic Enterprises (OASES) to accelerate healthcare innovation and strengthen Hong Kong's role as a leading hub for life sciences and medical technology in the Asia Pacific region.

Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced the completion of the Verona Pharma plc (Nasdaq: VRNA) (¡°Verona Pharma¡±) acquisition. Verona Pharma is now a wholly-owned subsidiary of Merck and the American Depositary Shares (ADS) of Verona Pharma will no longer be listed or traded on the Nasdaq Global Market.

Siemens Healthineers and the National University Hospital (NUH) Singapore have announced a strategic research collaboration to advance diagnostic solutions for Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD), which affects nearly 40% of adults in Singapore ¡ª a prevalence that is higher than the global average of 30.05%.

BD (Becton, Dickinson and Company) (NYSE: BDX), a leading global medical technology company, and Opentrons Labworks, Inc., recognized worldwide for accessible lab automation with more than 10,000 robotic systems deployed, today announced a multi-year collaboration. Together, BD and Opentrons will integrate robotic liquid-handling capabilities into BD single-cell multiomics instruments, automating critical experimental steps to accelerate and scale disease research and drug development.

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

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.

CareDx, Inc. (Nasdaq: CDNA) ¨C The Transplant Company™ ¨C a leading precision medicine company focused on the discovery, development, and commercialization of clinically differentiated, high-value healthcare solutions for transplant patients and caregivers ¨C 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 Table of Net Profits for Leading IVD Companies in 2025 H1 *The above table is sorted by net profit attributable to shareholders of the parent company in descending order. ..

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.

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¨C), ESR1-mutated advanced or metastatic breast cancer whose disease progressed after at least one line of endocrine therapy (ET).

R&D Investment Overview of R&D Investment by Leading IVD Companies in 2025 H1 * The above table is ranked from highest to lowest based on annual R&D expenditure as a percentage o..