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

As of 30 April 2026, a total of 86 China-listed companies related to the In Vitro Diagnostics (IVD) sector had released their 2025 annual reports, including 61 companies primarily engaged in IVD businesses and 25 companies with IVD-related operations.

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.

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.

The US Food and Drug Administration (FDA) issued finalized guidance on Monday outlining the criteria for authorizing emergency use of unapproved in vitro diagnostic tests (IVDs) during future public health emergencies.

Lunit (KRX:328130.KQ), a leading provider of AI for cancer diagnostics and therapeutics, and Agilent Technologies Inc. (NYSE: A), a global leader in life sciences, diagnostics, and applied chemical markets, today announced a nonexclusive collaboration to develop AI-based companion diagnostic solutions. The collaboration will leverage Lunit's AI technology and Agilent's expertise in tissue-based companion diagnostics to create advanced solutions that meet the demand of novel and complex biomarker assays in drug development.