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.
Produced by Mindray, it can automatically adjust the focal length of the microscope, and its patented technologies improve the image clarity and stability.
Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, today announced that the U.S. Food and Drug Administration (FDA) has approved Guardant360® CDx as a companion diagnostic (CDx) to identify patients with hormone receptor (HR)-positive, HER2-negative advanced or metastatic breast cancer harboring tumors with ESR1 mutations before radiographic progression who may benefit from treatment with ETCAMAH™ (camizestrant), AstraZeneca’s next-generation oral selective estrogen receptor degrader (SERD). Guardant360 CDx is the first FDA-approved liquid biopsy CDx for longitudinal testing in breast cancer, and this approval represents a major shift from therapy selection and switching post-radiographic progression to adaptive cancer management and early interception using pre-radiographic progression circulating tumor DNA (ctDNA) testing.
H.U. Group Holdings Inc. and its wholly owned subsidiary Fujirebio today announced that Health Canada has issued Class II Medical Device Licenses (MDL) for the Lumipulse G NfL Blood and the Lumipulse G pTau 217 Plasma assay for use on the fully automated LUMIPULSE® G immunoassay platform in the Canadian market.
Produced by AVE, it is a new serial of product with machine vision technology, low power screening, positioning, and high-power tracking recognition.
Stay up-to-date with the latest happenings in the rapidly evolving field of In Vitro Diagnostics (IVD) in China.
Readily Diagnostics AB, a point-of-care diagnostics company founded in 2022 and spun out of Uppsala University, has received a grant of approximately USD 970,000 (about 9 million SEK) from the Gates Foundation to develop an affordable test for the world's most common sexually transmitted infections (STIs).
Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA and precision medicine, today announced a new Signatera collaboration with Angiex, Inc., a privately held biotech company developing a portfolio of Nuclear-Delivered Antibody-Drug Conjugates™ (ND-ADCs).
Quest Diagnostics (NYSE: DGX), a leader in diagnostic information services, today announced two new developments for its Quest AD-Detect® portfolio of blood-based biomarker tests for Alzheimer's disease, with the goal of broadening access to quality blood tests for evaluating symptomatic patients for Alzheimer's disease.
Agilent Technologies Inc. (NYSE: A) today reported revenue of $1.88 billion for the third quarter ended July 31, 2026, representing growth of 8.1% reported and up 7.3% core(1) compared with the third quarter of fiscal year 2025.
Stratipath, a leader in AI-based precision diagnostics for breast cancer, and Aiforia, a pioneer in AI-driven diagnostics in pathology, today announced a strategic partnership. This collaboration aims to provide pathologists and oncologists with broader access to validated AI-powered diagnostic and prognostic tools and sets the stage for a long-term commercial relationship between the two companies.
Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that it has received FDA approval for expanded use of its PATHWAY® HER2 (4B5) and VENTANA® HER2 Dual ISH DNA Probe Cocktail tests. These companion diagnostics are now approved to assess HER2-positive status in metastatic gastroesophageal adenocarcinoma (GEA) patients, including those with gastric, gastroesophageal junction, and esophageal adenocarcinoma. The approval enables clinicians to identify HER2-positive GEA patients who may be eligible for HER2-targeted treatment with Jazz Pharmaceuticals' ZIIHERA® (zanidatamab-hrii). Two ZIIHERA-containing regimens are now FDA approved for the first-line treatment of adults with unresectable locally advanced or metastatic HER2-positive GEA.
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