It is a modular urinalysis workflow launched by DIRUI, which can meet the realistic needs of clinical laboratories for automated and high-throughput urine testing.
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 it has entered into a definitive agreement to acquire Proscia®, a provider of digital pathology software for clinical and life-sciences customers, in an all-cash transaction valued at $240 million in cash at closing and up to an additional $30 million based on achieving future performance milestones.
Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA and precision medicine, today announced that its multi-cancer early detection (MCED) assay has been granted Breakthrough Device designation (BDD) by the U.S. Food and Drug Administration (FDA). The BDD is designed for novel technologies that enable more effective diagnosis or treatment of life-threatening or irreversibly debilitating diseases or conditions.
Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, today announced that Guardant360® CDx has received CE-marking under Europe’s in Vitro Diagnostic Medical Devices Regulation as a companion diagnostic (CDx) to identify patients with estrogen receptor (ER)-positive, HER2-negative locally advanced or metastatic breast cancer who may benefit from treatment with ETCAMAH™ (camizestrant), AstraZeneca’s next-generation oral selective estrogen receptor degrader (SERD) and complete ER antagonist. Approval in Europe reinforces Guardant Health's commitment to enabling practice-changing ongoing monitoring across the world's largest healthcare markets.
Tempus (NASDAQ: TEM) today announced an expanded, multi-year collaboration to support the potential commercialization of intismeran autogene (V940/mRNA-4157), a novel, potential first-in-class individualized neoantigen therapy (INT) being evaluated in combination with KEYTRUDA® (pembrolizumab), Merck’s anti-PD-1 therapy, in patients with completely resected stage IIB-IV melanoma and other cancer types. Intismeran autogene is jointly developed by Moderna and Merck, known as MSD outside of the United States and Canada. The collaboration builds on joint efforts initiated last year and will support preparations for the potential commercialization of intismeran autogene.
CellCarta, a leading global CRO laboratory to the biopharmaceutical industry, today announced a strategic partnership with Waters Corporation, a global leader in life sciences and diagnostics, creating a framework to jointly pursue companion diagnostic (CDx) and next-generation flow cytometry opportunities with pharmaceutical and biotechnology companies.
SOPHiA GENETICS (NASDAQ: SOPH) and Myriad Genetics, Inc., (NASDAQ: MYGN) today announce a collaboration to advance new prostate cancer-specific genomic instability score (PrGIS) technology to support precision oncology approaches with AstraZeneca (LSE/STO/NYSE: AZN). PrGIS is a novel biomarker signature designed to assess chromosomal instability associated with homologous recombination deficiency (HRD) in prostate cancer patients. The collaboration aims to advance PrGIS in clinical trials and expand access to precision oncology medicines through potential companion diagnostic solutions.
Truvian Health (“Truvian”), a diagnostics company transforming routine blood testing through its automated benchtop platform, today announced a strategic alliance withSiemens Healthineers to advance the TruVerus™ platform and explore opportunities to expand access to high-quality blood testing across a broader range of laboratory and healthcare settings.
Revvity, Inc. (NYSE: RVTY) today announced the launch of the GSP® T1D 3plex kit, a fully automated, CE-IVDR-certified, multiplex autoantibody (AAb) detection solution to enable population-wide screening programs that identify children at risk of developing type 1 diabetes (T1D) before symptoms appear.
Werfen today announced that its Aptiva Antiphospholipid Syndrome (APS) Immunoglobulin A (IgA) Reagent has received both U.S. Food and Drug Administration (FDA) 510(k) clearance and CE Mark under the European Union’s In Vitro Diagnostic Medical Devices Regulation (IVDR). Together, these milestones complete the Aptiva APS testing portfolio, which now offers all three APS isotypes, IgA, IgG, and IgM, for both anti-cardiolipin (aCL) and anti-beta 2 glycoprotein 1 (aβ₂GP1) antibodies.
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.
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