Roche Receives FDA Nod for Lung Cancer Companion Diagnostic
The FDA has approved Roche’s VENTANA MET (SP44) RxDx Assay, the first companion diagnostic for lung cancer.
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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 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.
Roche and ALZpath Partner on Alzheimer’s Blood Test
ALZpath and Roche will develop a blood test for Alzheimer’s diagnosis using the pTau217 antibody on the Roche Elecsys platform.
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Roche and Hitachi High-Tech Extend Partnership
Roche and Hitachi High-Tech have extended their partnership for at least 10 more years and will continue to focus on advancing lab tech.
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Roche’s Lipoprotein Blood Test Gets Breakthrough Device Designation
Roche announced that its Tina-quant lipoprotein Lp(a) RxDx assay received Breakthrough Device Designation from the FDA.
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CLP March/April 2024 Tech Guide: Urinalysis
The CLP March/April 2024 Tech Guide in Clinical Lab Products (CLP) showcases a diverse array of products from seven laboratory providers.
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Roche Announces FDA Approval of HPV Self-Collection Solution
che received FDA approval for its HPV self-collection solution, allowing individuals to collect their own samples.
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Roche’s Early Alzheimer’s Blood Test Gets Breakthrough Device Designation
Roche’s Elecsys pTau217 assay could help rapidly broaden access to a more timely and accurate diagnosis of Alzheimer’s disease. Â
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FDA Approves Roche’s Test to Screen for Malaria in Blood Donors
Roche announced U.S. FDA approval of the cobas Malaria test for use on the cobas 6800/8800 Systems to aid healthcare professionals.
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It’s Elementary. Sherlock Bio Provides an Assay Development Solution
Sherlock Bio is making its proprietary AI platform freely available to anyone interested in developing diagnostics assays.
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Roche Showcases New Digital Solutions to Improve Lab Optimization
Roche’s new suite of cloud-based solutions provides actionable insights to optimize operational outcomes in labs and point-of-care settings.
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Roche Collaborates with PathAI to Expand Digital Pathology Capabilities for CDx
PathAI will exclusively work with Roche Tissue Diagnostics to develop AI-enabled digital pathology algorithms for companion diagnostics.
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January/February 2024 Tech Guide: Immunoassay Analyzers
The January/February 2024 Tech Guide that appears in CLP features a wide-range of products from top laboratory providers.
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Next-Generation qPCR System Launched by Roche
The new qPCR system raises the bar for performance and usability while bridging the gap between research and in vitro diagnostics.
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Roche’s Neurofilament Light Chain Test Gets Breakthrough Device Designation
Roche’s Elecsys NfL test for MS received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA).Â
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Roche Expands HPV Testing for Cobas 5800 Molecular System
Roche announced the U.S. FDA approved the cobas HPV test for use on its next-generation cobas 5800 molecular instrument.
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Roche Collaborates with Ibex, Amazon on AI-Enabled Digital Pathology Solutions for Cancer
Roche is collaborating with Ibex and AWS to enable pathology labs to access AI-powered decision support tools to support cancer diagnosis.
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