Produced by AVE, it has a high degree of automation, and the front end is equipped with automatic sample delivery device.

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

Agilent Technologies Inc. (NYSE: A) today announced that it has received U.S. Food and Drug Administration (FDA) approval for the PD‑L1 IHC 28‑8 pharmDx assay as a companion diagnostic to identify patients with esophageal squamous cell carcinoma (ESCC), gastric, gastroesophageal junction (GEJ), and esophageal adenocarcinoma who may be eligible for treatment with OPDIVO® (nivolumab) or OPDIVO QVANTIG® (nivolumab and hyaluronidase‑nvhy), Bristol Myers Squibb’s PD‑1‑targeted immunotherapeutic agents. PD-L1 IHC 28-8 pharmDx is approved for exclusive use with the Agilent Autostainer Link 48 advanced staining solution.

Only taking urine dry chemistry and urine formed element as the basic detection of urine routine is still insufficient in the diagnosis and differential diagnosis of urinary system diseases.

Roche (SIX: RO, ROP; OTCQX: RHHBY) announced today that it introduces the cobas® HDV test for use on the cobas® 5800/6800/8800 systems, a diagnostic tool for the detection and quantification of Hepatitis D Virus (HDV) RNA, in countries accepting the CE mark. Available on the industry-leading cobas 5800/6800/8800 systems, Roche aims to help healthcare providers in identifying patients and monitoring their care more effectively alongside newly available treatments.

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

iHealthScreen, Inc., a healthcare AI company developing Software as a Medical Device (SaMD) for retinal and cardiovascular disease screening and preventive healthcare, today announced FDA 510(k) clearance (K253704) for iPredict-DR™, its AI-powered software that automatically detects more than mild diabetic retinopathy (mtmDR) in adults with diabetes not previously diagnosed with the condition.

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.