Implementation of in Vitro Diagnosis of Thrombosis and Hemostasis in the Chinese Market

Stay up-to-date with the latest happenings in the rapidly evolving field of In Vitro Diagnostics (IVD) in China.

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.

At present, the coagulation tests are mainly applied for the screening of thrombotic diseases and hemorrhagic diseases, and the routine six items are relatively common in clinical practice (Table 3), mainly including prothrombin time (PT), activated partial thromboplastin time (APTT), thrombin time (TT), fibrinogen (FIB), D-dimer (D-D), and fibrin (pro) degradation products (FDP).

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 disclosed their 2025 half-year reports.

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.

Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, and Quest Diagnostics (NYSE: DGX), a leader in diagnostic information services, today announced a broad strategic collaboration to make Guardant’s Shield™ blood-based screening test available to physicians and patients served by Quest in the United States.