Roche Receives CE Mark for PCR Test Targeting Bacterial Vaginosis and Candida Vaginitis
The cobas BV/CV assay aims to improve diagnostic accuracy over traditional microscopy and pH testing methods for symptomatic patients.
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Roche Gains CE IVDR Approval for Expanded HER2 Companion Diagnostic
VENTANA HER2 (4B5) test is now CE-IVDR approved to identify HER2-ultralow breast cancer and HER2-positive biliary tract cancer patients.
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Should Labs Add Lp(a) Testing to Their Menus?
Lipoprotein(a), or Lp(a), is a genetically determined and under-recognized cardiovascular disease risk factor.
HER2-ultralow Metastatic Breast Cancer Companion Diagnostic Approved by FDA
Roche’s PATHWAY anti-HER2/neu (4B5) test has received FDA approval to ID patients with HR-positive, HER2-ultralow metastatic breast cancer.
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Roche Lp(a) Test Gets FDA Clearance for Cardiovascular Risk Assessment
Roche’s Tina-quant Lp(a) Gen.2 Molarity assay received FDA 510(k) clearance, supporting more precise cardiovascular risk assessment.
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FDA Clears Roche Point-of-Care STI Tests
The FDA granted 510(k) clearance for Roche STI multiplex panels, enabling rapid diagnosis of chlamydia, gonorrhea, and Mycoplasma genitalium.
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Roche Gets FDA Clearance for Highly Sensitive B-cell Lymphoma Test
A new test for Roche received FDA clearance as a sensitive diagnostic tool to differentiate B-cell lymphomas for improved diagnosis.
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Roche’s Digital Pathology System Gets New FDA Clearance for High-Volume Slide Scanner
Roche’s Digital Pathology Dx platform received additional FDA clearance, now incorporating the VENTANA DP 600 slide scanner.
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Roche Launches cobas Mass Spec Solution
Roche has received CE mark approval for its cobas Mass Spec solution, marking a milestone in its global launch of mass spectrometry testing.
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Roche and Sheba Medical Center Partner to Improve NSCLC Diagnosis Using AI-Powered Digital Pathology
Roche and Sheba Medical Center’s ARC are collaborating to enhance NSCLC diagnosis and treatment using AI-driven digital pathology tools.
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Roche Presents New Alzheimer’s Disease Diagnostic Data
Roche announced the Elecsys Amyloid Plasma Panel shows promising results in accurately ruling out amyloid pathology in Alzheimer’s disease.
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FDA Approves Roche CDx for Gastric and Gastroesophageal Junction Cancer Treatment
Roche’s VENTANA CLDN18 RxDx Assay identifies CLDN18 protein expression in gastric and gastroesophageal junction cancer patients.
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Roche Launches Test That Simultaneously Detect 12 Respiratory Viruses
Roche introduced the cobas Respiratory flex test which uses TAGS technology to identify up to 15 pathogens in a single PCR test.
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Roche Expands Digital Pathology Platform with AI-Driven Algorithms
Roche’s navify digital pathology enterprise software now integrates a range of AI-driven algorithms, enabling enhanced cancer diagnostics.
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Roche Adds AI-Powered Solution to its Digital Pathology Platform
Qritive has partnered with Roche to integrate its AI-powered cancer diagnostic tools with the Roche navify Digital Pathology platform.
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Roche Enhances Response to Mpox Outbreak with Advanced Diagnostic Tests
Roche announced its continued support in addressing the global mpox emergency by partnering with healthcare providers and organizations.
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Roche to Showcase ‘Labs of the Future’ Solutions at ADLM 2024
Roche will showcase solutions at ADLM 2024 that demonstrate how its integrated systems and data solutions optimize laboratory systems.
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CLP May/June 2024 Tech Guide: Hematology and Coag Analyzers
The CLP May/June 2024 Tech Guide that appears in Clinical Lab Products (CLP) features a wide-range of products from top laboratory providers.
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