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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–), 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..

2.2.1 Clinical Test Items Overview of Routine Coagulation Function Items At present, the coagulation tests are mainly applied for the screening of thrombotic diseases and hemorrhagic diseases, and ..

Biolinq Incorporated, a pioneering developer of precision multi-analyte biosensors to improve metabolic health, today announced the U.S. Food and Drug Administration has granted De Novo Classification for its lead product, Biolinq Shine™. With this classification, Biolinq has a clear path forward to scale a new generation of wearable sensors designed for comfort, simplicity, and global reach.

Hitachi High-Tech Corporation ("Hitachi High-Tech"), and ELITechGroup S.p.A. (Head Office: Italy, "ELITech") have entered a Collaboration, Manufacturing and Supply Agreement (the "Agreement") in the field of molecular testing for infectious disease.

As of August 31, 2025, China has 83 publicly listed companies related to in vitro diagnostics (IVD), including 62 whose core business is IVD and 21 with IVD-related operations. Among the 62 core IVD companies, 59 have..

Myriad Genetics (Nasdaq: MYGN), a leader in molecular diagnostic testing and precision medicine, and SOPHiA GENETICS (Nasdaq: SOPH), an AI technology company transforming precision medicine, announced a strategic collaboration to develop and provide pharmaceutical companies with an innovative global liquid biopsy companion diagnostic (CDx) test. This partnership will leverage Myriad’s advanced laboratory capabilities in the U.S. to support global testing for clinical trials and SOPHiA GENETICS’ broad, decentralized network of more than 800 connected institutions in more than 70 countries for global test deployment.

The U.S. Commerce Department said on Wednesday it has opened new national security investigations into the import of personal protective equipment, medical items, robotics and industrial machinery.

Shield is the first and only blood test to receive full FDA approval as a primary screening option for colorectal cancer in average-risk adults aged 45 and older. Through a multi-year agreement, Quest’s provider clients that order lab testing from Quest will be able to directly order Shield through their existing Quest account and electronic health record (EHR). Quest provided healthcare connectivity solutions to approximately 650,000 clinician and hospital accounts last year. Quest’s provider clients will also be able to refer patients to Quest’s 2,000 patient service centers and 6,000 in-office phlebotomists for blood draws in the United States. In addition, Quest’s national commercial sales team will proactively educate primary care physicians and obstetricians and gynecologists about the test, accelerating awareness among Quest’s ordering providers. Shield is expected to be available for physician order through Quest in the first quarter of 2026.

Riken Genesis Co., Ltd. (Riken Genesis) and Burning Rock Biotech Limited (NASDAQ: BNR, “Burning Rock”) today announced that the OncoGuide™ OncoScreen™ Plus CDx System based on OncoScreen™ Plus to be used as a companion diagnostic for AstraZeneca’s capivasertib has received Manufacturing and Marketing Approval from Japan’s Ministry of Health, Labour and Welfare (MHLW).

Tempus AI, Inc. (NASDAQ: TEM), a technology company leading the adoption of AI to advance precision medicine and patient care, today announced it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its RNA-based Tempus xR IVD device. xR IVD will be offered as a life sciences tool to support drug development programs.