The major brands in China’s urinalysis market are URIT, DIRUI, AVE, etc. URIT produced China’s first urine analyzer in 1984. And after nearly 40 years’ strenuous cultivation, it pioneered the modular urine analysis workflow using deep learning artificial intelligence (AI) image recognition technology.
Stay up-to-date with the latest happenings in the rapidly evolving field of In Vitro Diagnostics (IVD) in China.
A blood test identified patients with a treatable neurometabolic disease in a prospective trial, suggesting that it can be used to improve diagnosis of a condition that is currently detected using an invasive procedure.
Cue Health, a healthcare technology company, announces an industry breakthrough as the first company to receive De Novo authorization from the U.S. Food and Drug Administration (FDA) for its Cue COVID-19 Molecular Test, designed for both home and point-of-care use.
According to Kalorama estimates, the Romanian IVD market, serving 18.8 million residents, grew to $464 million in 2022.
Foundation Medicine, Inc., a pioneer in molecular profiling for cancer, today announced that it has entered a strategic collaboration with Merck KGaA, Darmstadt, Germany to develop FoundationOne®Liquid CDx and FoundationOne®CDx as companion diagnostics in the U.S. market for selected marketed and pipeline treatments.
Global life sciences company Labcorp has introduced a new liquid biopsy test called Labcorp Plasma Focus.
Cepheid announced that it has received the CE mark for Xpert NPM1 Mutation, a molecular in vitro diagnostic test for the quantification of mutant NPM1 mRNA transcripts (types A, B and D in exon 12) in peripheral blood specimens from patients with Acute Myeloid Leukemia (AML).
Agilent Technologies Inc. (NYSE: A) reported revenue of $1.72 billion for the second quarter ended April 30, 2023, an increase of 6.8% compared to the second quarter of 2022 and up 9.5% on a core(1) basis.
Welcome and thank you for being a part of the 20th China Association of Clinical Laboratory Practice Expo (CACLP) and the 3rd China IVD Supply Chain Expo (CISCE), which are set to kick off from 28-30 May 2023 at Nanchang Greenland International Expo Center.
Hologic Inc. (Nasdaq: HOLX) announced today that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for the company’s Panther Fusion® SARS-CoV-2/Flu A/B/RSV assay. This assay is a molecular diagnostic test that detects and differentiates four of the most prevalent respiratory viruses that can exhibit similar clinical symptoms: severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), influenza A (flu A), influenza B (flu B) and respiratory syncytial virus (RSV).
Thermo Fisher Scientific Inc. (NYSE: TMO), the world leader in serving science, today announced that the U.S. Food and Drug Administration (FDA) has cleared the Thermo Scientific B·R·A·H·M·S PlGF plus KRYPTOR and B·R·A·H·M·S sFlt-1 KRYPTOR novel biomarkers, the first and only immunoassays to receive breakthrough designation and clearance for the risk assessment and clinical management of preeclampsia, a severe pregnancy complication.
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