According to a document released by all five authorities, by 2030, intelligent diagnosis and treatment assistance will be universal in basic terms across China's primary-level medical institutions, including community and village clinics. Meanwhile, hospitals at or above the second grade in China's three-tier hospital system will widely adopt AI technologies such as intelligent medical-imaging diagnosis and clinical decision-making support technologies.

According to the results of the basic research, different medical institutions have selected different imported and domestic brand instruments: 38 domestic and 58 imported.

Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, today announced that the U.S. Food and Drug Administration (FDA) has approved Guardant360® CDx as a companion diagnostic to identify patients with BRAF V600E-mutant metastatic colorectal cancer (mCRC) who may benefit from treatment with BRAFTOVI® (encorafenib) in combination with cetuximab and chemotherapy in accordance with the approved product labeling.

HORIBA, a global leader in analytical and measurement technology, has obtained CE IVDR certification for its new Yumizen H500 CRP benchtop hematology analyzer which delivers a simultaneous 5-part extended differential (DIFF) and rapid C-Reactive Protein (CRP) whole blood measurement. Based on its award winning Yumizen H500 compact analyzer, the new instrument is designed for small laboratories and ideal for use in a variety of hospital testing settings for rapid and highly accurate detection of infection and inflammation.

BIOMAKERS, a precision medicine and oncology intelligence company headquartered in San Francisco, today announced the closing of an additional $8 million. The financing marks a key inflection point as the company transitions from building a differentiated global diagnostics and data infrastructure to scaling an AI-native platform – while continuing to expand its comprehensive molecular testing reach across Latin America – designed to accelerate drug and diagnostic development, improve clinical trial execution, and enable precision oncology at global scale.

Truvian Health (“Truvian”), a diagnostics company redefining routine blood testing, today announced U.S. Food and Drug Administration (FDA) clearance for the Complete Blood Count (CBC) on its TruVerus™ multi‑modal blood testing system (K251249).

Roche's (ROG.S), opens new tab Genentech said on Tuesday it will more than double its initial investment in a biomanufacturing facility in North Carolina to about $2 billion, as the companies look to further boost their $50 billion investment in the U.S.

Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, today announced a multi-year collaboration with Merck, known as MSD outside the United States and Canada, to support the development and commercialization of Merck’s oncology portfolio using the Guardant Infinity™ Smart platform.

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

BillionToOne, Inc. (NASDAQ: BLLN), a next-generation molecular diagnostics company with a mission to create powerful and accurate tests that are accessible to all, today announced a collaboration with Epic, the nation's most widely used comprehensive electronic health record (EHR). The agreement, signed in December 2025, will integrate BillionToOne's prenatal and oncology testing portfolio with Epic's Aura diagnostics suite.

BD (Becton, Dickinson and Company) (NYSE: BDX), a leading global medical technology company, today announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for the EnCor EnCompass™ Breast Biopsy and Tissue Removal System, a state-of-the-art multi-modality breast biopsy system designed to provide clinicians with flexibility across breast imaging modalities in the diagnosis of breast disease.

BGI Genomics (300676.SZ), opens new tab and Roche Diagnostics (ROG.S), opens new tab have rolled out tests for Alzheimer's disease in China, the companies said, in an effort to expand access to easier-to-use diagnosis and monitoring choices for patients with the brain-wasting condition.