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.

Thermo Fisher Scientific, the world leader in serving science, has received approval from the U.S. Food and Drug Administration (FDA) for its Ion Torrent™ Oncomine™ Dx Target Test as a companion diagnostic (CDx) to identify patients eligible for treatment with Servier Pharmaceuticals, LLC’s VORANIGO® (vorasidenib) tablets. VORANIGO is an isocitrate dehydrogenase-1 (IDH1) and isocitrate dehydrogenase-2 (IDH2) inhibitor indicated for the treatment of adult and pediatric patients 12 years and older with Grade 2 astrocytoma or oligodendroglioma with a susceptible IDH1 or IDH2 mutation following surgery including biopsy, sub-total resection or gross total resection. As the first targeted therapy for Grade 2 IDH-mutant glioma, VORANIGO provides a new care path for patients with extremely limited treatment options.

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

Auckland-based biotechnology company DNAiTECH has secured NZD $1 million in funding to advance its development of instant diagnostic tests that do not require a laboratory.

Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the VENTANAⓇ CLDN18 (43-14A) RxDx Assay is the first U.S. Food and Drug Administration (FDA) approved immunohistochemistry (IHC) companion diagnostic for determining CLDN18 protein expression in tumours of patients with gastric or gastroesophageal junction (GEJ) adenocarcinoma. These patients now may be eligible for treatment with Astellas' targeted therapy VYLOYTM (zolbetuximab).

Massachusetts and Singapore-based biotechnology company Sunbird Bio has raised $14m to advance the clinical development of its blood-based diagnostic platform for neurological disorders and early-stage cancer.

Yourgene Health (part of the Novacyt group of companies), a leading international molecular diagnostics group, announces that it has received accreditation under the new EU requirements of the in vitro diagnostic regulation (IVDR) for the Yourgene® Cystic Fibrosis Base assay. The Yourgene Cystic Fibrosis Base assay is a Class C in vitro medical device under IVDR and is intended for use by healthcare professionals within a molecular laboratory environment.

CareDx, Inc. (Nasdaq: CDNA) — The Transplant Company™ — a leading precision medicine company focused on the discovery, development, and commercialization of clinically differentiated, high-value healthcare solutions for transplant patients and caregivers —today reported preliminary financial results for the third quarter ended September 30, 2024.

Abbott (NYSE: ABT) today announced financial results for the third quarter ended Sept. 30, 2024.

bioMérieux, a world leader in the field of in vitro diagnostics, announces the CE-marking of VIDAS® VITAMIN B12 TOTAL, an automated quantitative test for use on the VIDAS® immunoassay instruments, for the measurement of total Vitamin B12 concentration in human serum or plasma.

Prenetics Global Limited (NASDAQ: PRE), a leading health sciences company, today announced that Tencent has made a strategic US$30 million investment in Insighta, a Hong Kong-based early cancer detection company. This investment values Insighta at US$200 million and underscores Tencent’s endeavor to advancing AI-powered innovations in healthcare.