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.

China plans to allow the establishment of wholly foreign-owned hospitals in certain cities and regions across the country, according to an official document unveiled on Sunday.

Healgen Scientific LLC, a leading innovator in diagnostic solutions, announced the U.S. Food and Drug Administration (FDA) has granted De Novo marketing authorization for Healgen Rapid Check® COVID-19/Flu A&B Antigen Test for over-the-counter (OTC) use. Click here for FDA Release. The FDA's De Novo pathway is designed for medical devices that do not have legally marketed comparison device and is a unique opportunity for development of a new device classification that can improve patient care and outcomes.

Seegene Inc., a leading South Korean company providing a total solution for PCR molecular diagnostics, announced today the finalization of a partnership agreement with Werfen, a worldwide leader in specialized diagnostics, on the technology-sharing initiative. Under the agreement, Seegene and Werfen will set up a NewCo in Spain, Werfen-Seegene, upon the conclusion of mandatory government approvals anticipated by the first half of 2025.

The clinical application of molecular diagnostic technology is mainly in the form of detecting nucleic acid markers, including reagents and instruments, which are regulated by the National Medical Product Administration (hereinafter referred to as NMPA).

Exact Sciences Corp. (NASDAQ: EXAS), a leading provider of cancer screening and diagnostic tests, today announced the U.S. Food and Drug Administration (FDA) approved the Cologuard Plus™ test, the company’s next generation multitarget stool DNA test. The Cologuard Plus test is now approved for adults ages 45 and older who are average risk for colorectal cancer (CRC).

Agilent Technologies Inc. (NYSE: A) today announced a new strategic partnership with the National University of Singapore (NUS), acting through the Yong Loo Lin School of Medicine (NUS Medicine), to establish the NUS-Agilent Center of Excellence (CoE) in Cell Metabolism. This scientific collaboration will advance cardiovascular and metabolic disease translational research over the next four years.

An international team has tracked the protein changes that occur in cerebrospinal fluid (CSF) during disease progression in individuals with autosomal dominant forms of Alzheimer's disease.

Diasorin (FTSE MIB: DIA) today announced it has submitted a 510(k) premarket notification to the U.S. Food and Drug Administration (FDA) for the LIAISON PLEX® Gram-Negative Blood Culture Assay, the second of the three molecular multiplexing panels for Blood Culture identification on the LIAISON PLEX®.

Following the passage of continuing resolutions (CR) by the US Senate and the House of Representatives this week, lab test reimbursement cuts and price reporting requirements called for under the Protecting Access to Medicare Act (PAMA) are likely to be delayed one year.

QIAGEN (NYSE: QGEN; Frankfurt Prime Standard: QIA) today announced that its QIAstat-Dx syndromic testing systems and associated assays have received CE-marking under the European Union's new In-Vitro Diagnostic Medical Devices Regulation (IVDR).