It is a product of URIT. On the basis of the original urine routine analysis workflow, US-3000 series has added urine-specific protein module and urine biochemistry detection module to realize one-stop detection of urine physics, dry chemistry, formed element, specific protein, and biochemical quantification. On the basis of all-in-one machine, US-1680 series adds online functions to meet the needs of different markets.
Stay up-to-date with the latest happenings in the rapidly evolving field of In Vitro Diagnostics (IVD) in China.
Teal Health, creators of the Teal WandTM, the first and most accurate FDA-authorized self-collection device for at-home HPV cervical cancer screening, today announced $22 million in Series A funding to meet accelerating consumer demand and expand access ahead of broad insurance coverage beginning in January 2027.
Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA and precision medicine, today announced that its Signatera test has received regulatory approval from Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) as a companion diagnostic (CDx) in muscle-invasive bladder cancer (MIBC).
Pattern Bioscience, an innovator in rapid diagnostic technologies for bacterial infections, today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation for its Urine ID/AST Panel. The Urine ID/AST Panel is the company’s second assay to receive the designation, following the Pneumonia ID/AST Panel. It reflects Pattern’s continued focus on expansion of a menu of rapid, direct-from-specimen assays.
Siemens Healthineers and Novo have announced a collaboration focused on advancing care for people living with metabolic dysfunction-associated steatotic liver disease (MASLD) and its progressive form, metabolic dysfunction-associated steatohepatitis (MASH). The companies are engaged in several projects to strengthen disease awareness, support earlier assessment of the disease, and help expand patient access to non-invasive blood testing.
bioMérieux, a world leader in the field of in vitro diagnostics, announces that its BIOFIRE® SPOTFIRE® Respiratory/Sore Throat plus (R/STplus) Panel and BIOFIRE® SPOTFIRE® Respiratory/Sore Throat plus (R/STplus) Panel Mini have been CE-marked under the IVDR*. The certification includes conformity assessment for near-patient testing, enabling its use outside traditional laboratories, directly at the point of care. These multiplex PCR** tests can simultaneously detect the most common pathogens responsible for respiratory and sore throat infections, within a timeframe aligned with a typical patient visit.
Produced by Mejer, it is the first instrument in China that uses S-M staining method combined with AI technology to automatically identify urine formed elements.
Amoy Diagnostics Co., Ltd. (“AmoyDx,” SZSE: 300685) today announced that its AmoyDx® HRD Complete Panel has received certification under the European Union In Vitro Diagnostic Medical Devices Regulation (IVDR) by TÜV SÜD Product Service GmbH for use as a companion diagnostic to aid in identifying patients with metastatic castration-resistant prostate cancer (mCRPC) and BRCA1/2 mutations ( germline and /or somatic) who may be eligible for treatment with olaparib monotherapy who have progressed following prior therapy that included a novel hormonal agent.
Veracyte, Inc. (Nasdaq: VCYT), a leading cancer diagnostics company, today announced its acquisition of Convergent Genomics. The acquisition adds Convergent Genomics’ UroAmp platform, including its proprietary urinary tumor DNA (utDNA) technology, to Veracyte’s product portfolio. To date, UroAmp has been clinically validated in non-muscle invasive bladder cancer (NMIBC), including therapy-response monitoring and post-treatment surveillance.
Burning Rock Biotech Limited (NASDAQ: BNR, the “Company” or “Burning Rock”), a company focused on the application of next-generation sequencing (NGS) technology in the field of precision oncology, today reported financial results for the three months ended June 30, 2026.
Sysmex Europe SE, a leader in diagnostic and healthcare solutions, and Cytek Biosciences, Inc. (Nasdaq: CTKB), a leader in spectral flow cytometry technology, today announced a strategic collaboration across over a dozen European countries to enhance clinical flow cytometry workflows and expand access to innovative diagnostic solutions.
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