With the development of artificial intelligence technology, it plays an important role in laboratory medicine, especially in the automatic identification of cell morphology. The new generation of AI technology shows the characteristics of deep learning, autonomous learning, human-machine collaboration, and so on.

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

Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA and precision medicine, today announced that Signatera has received certification as a Class C device under the European Union’s In Vitro Diagnostic Regulation (IVDR).

Roche (SIX: RO, ROP; OTCQX: RHHBY) announced today that its Elecsys IGRA TB test has received the CE Mark, introducing a new blood testing solution for identifying tuberculosis infection (TBI, also known as latent TB) in routine laboratory settings. The new solution enables fast, simple, and efficient diagnosis, and can provide results in under 24 hours. The Interferon Gamma Release Assay (IGRA) itself takes just 19 minutes per patient to process, which is approximately half the time of currently used methods. Laboratories now have an option for IGRA testing, with faster turnaround and scalable throughput on Roche’s systems.

bioMérieux, a world leader in the field of in vitro diagnostics, today announces the launch of GENE-UP® PROBIOTIC SPECIES ID, a first-of-its-kind commercialized species-level identification PCR solution for in-house quality control teams and external laboratory partners. This new solution verifies dietary supplement label claims in 90 minutes or less, helping bypass the cost, complexity, and delays of traditional workflows.

Today, Biocartis, an innovative molecular diagnostics company, and Discovery Life Sciences (“Discovery”), a global leader in biomarker specialty laboratory services and biospecimen solutions, are pleased to announce a strategic collaboration to deliver seamless, end-to-end precision oncology solutions to pharmaceutical and biotech customers worldwide.

Beckman Coulter Diagnostics, a global leader in clinical diagnostics and a Danaher company, today announced it received CE Mark under IVDR for its Access p-Tau217 assay, a blood test designed to support clinical evaluation of amyloid pathology in patients with signs and symptoms of cognitive decline. The company also introduced its high-specificity Access BD-pTau217 Research Use Only (RUO) assay at the Alzheimer's Association International Conference (AAIC) 2026 in London.

Visby Medical, the at-home diagnostics company, today announced U.S. Food and Drug Administration (FDA) clearance for the Visby Medical Flu and COVID-19 Test, the first multi-viral at-home PCR test. This marks Visby’s second over-the-counter PCR test and expands the company’s growing portfolio of rapid molecular diagnostics designed for home use.

We are proud to announce that Hartwig Medical Foundation has received CE certification under the European In Vitro Diagnostic Regulation (IVDR) for Hartwig Medical OncoAct (OncoAct), our software solution for cancer diagnostics based on Whole Genome Sequencing (WGS) in solid tumors.

Today, the World Health Organization (WHO) has added the first molecular diagnostic test for Bundibugyo virus (BDBV) to its Emergency Use Listing (EUL). The test detects the virus by identifying its genetic material in blood samples, helping confirm infection rapidly and accurately.

Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, today announced its Shield™ blood test for colorectal cancer screening (CRC) is now covered for eligible UnitedHealth Group (UHG) members, making it the first major commercial insurer to provide coverage for adults 45 or older amid rising CRC rates for adults under 65 and mortality for younger adults as the leading cause of cancer death for those under 50.

CareDx, Inc. (Nasdaq: CDNA), a leading precision medicine diagnostics company in transplant, specialty oncology, and cell therapy today announced the successful completion of its previously announced acquisition of Naveris, following the satisfaction of all closing conditions. The transaction terms were disclosed at the time of announcement in April 2026.