Original from: Tempus Tempus AI, Inc. (NASDAQ: TEM), a technology company leading the adoption of AI to advance precision medicine and patient care, today announced that it has entered into a definitive ..

Roche Diagnostics Receives NMPA Approval for Ionify Vitamin D Test Kit Roche Diagnostics announced that its Ionify® 25-Hydroxy Vitamin D Assay based on liquid chromatography-tandem mas..

Original from: business wire Bruker Corporation (Nasdaq: BRKR) today announced the acquisition of the DISQVER® clinical metagenomics platform from Noscendo GmbH. DISQVER® enables me..

Original from: Abbott Abbott (NYSE: ABT) today announced financial results for the second quarter ended June 30, 2026. - Second-quarter sales increased 13.0 percent on a reported basis and ..

Original from: business wire Meridian Bioscience, Inc., a leading global provider of diagnostic testing solutions and life science raw materials, announced today that Health Canada has granted a license ..

QIAGEN N.V. (NYSE: QGEN; Frankfurt Prime Standard: QIA) today announced the launch of the CE-IVDR-certified QIAstat-Dx BCID GN Plus AMR Panel, establishing a comprehensive bloodstream infection testing offering on the QIAstat-Dx platform in Europe.

Personalis, Inc. (Nasdaq: PSNL), a leader in advanced genomics for precision oncology, today announced that it has achieved UKCA (United Kingdom Conformity Assessed) marking for its NeXT Personal Dx test. This critical regulatory milestone enables the clinical use of Personalis’ ultrasensitive Minimal Residual Disease (MRD) detection technology across Great Britain, encompassing England, Wales, and Scotland.

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. At present, the new combin..

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.

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.

2 Product and Technology Innovation of Urinalysis in China 2.1 Overview Urinalysis is the basic routine item of clinical laboratory, which is usually based on urine dry chemistry analysis and urine..

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.

Cytiva Localizes Production of Automated Industrial Chromatography Columns in China Cytiva, a Danaher operating company, has announced the local production of its automated industrial chro..

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.