From January 2024 and June 2025, the U.S. Food and Drug Administration (FDA) approved 39 in-vitro toxicology testing products through the 510(k). This period marked a significant reshaping of the global market: Chinese companies, driven by rapid product iteration and precise market positioning, surged in the market share. At the same time, the worsening fentanyl crisis in the U.S. fueled an unprecedented demand for fentanyl testing, making it the most competitive and dynamic segment in the field.

Conventional thrombosis and hemostasis diagnostic applications are mainly concentrated on screening for bleeding disorders and diagnosis of bleeding origins, with a relatively narrow scope of application and relatively poor accuracy.

Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, today reported financial results for the quarter ended September 30, 2024.

QIAGEN N.V. (NYSE: QGEN; Frankfurt Prime Standard: QIA) today announced results for the third quarter and first nine months of 2024.

As of 31 October, 2024, all mainland-listed Chinese IVD companies have released their third-quarter financial reports. This summary provides insights into 50 main IVD enterprises and 20 IVD-related enterprises for reference. Notably, Hong Kong-listed companies are not included.

CareDx, Inc. (Nasdaq: CDNA) – today announced financial results for the third quarter ended September 30, 2024.

QIAGEN (NYSE: QGEN; Frankfurt Prime Standard: QIA) today announced that the U.S. Food and Drug Administration (FDA) has cleared the QIAstat-Dx Meningitis/Encephalitis Panel for clinical use.

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

Revvity, Inc. (NYSE: RVTY), today reported financial results for the third quarter ended September 29, 2024.

Illumina, Inc. (Nasdaq: ILMN) ("Illumina" or the "company") today announced its financial results for the third quarter of fiscal year 2024. The financial results for YTD 2024 and Q3 2023 and YTD 2023 include the financial results for GRAIL which was spun off on June 24, 2024.

Sunbird Bio, a biotechnology company developing proprietary blood-based technologies to improve diagnosis and treatment of neurological disorders and early-stage cancer, announced new data demonstrating that the company’s blood-biomarker alpha synuclein (α-synuclein) signatures accurately detect the aggregation of α-synuclein in the brain from a simple blood draw. Results from the study, which will be shared in a poster presentation (#116) on October 31 at the Clinical Trials on Alzheimer’s Disease (CTAD) international conference, demonstrate that Sunbird’s technology could provide blood-based diagnosis of multiple neurodegenerative diseases, including Parkinson’s disease, with high accuracy.

As part of ongoing efforts to enhance quality-assured testing options, the World Health Organization (WHO) has listed two additional mpox in vitro diagnostics under its Emergency Use Listing (EUL) procedure. WHO’s EUL is based on the review of quality, safety and performance data in compliance with international standards while addressing the specific needs of low- and middle-income countries (LMICs).