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Interconnected Clinical Lab Devices Can Increase Operational Capabilities

Interconnected Clinical Lab Devices Can Increase Operational Capabilities

by Oscelle Boye, MBiomed | Apr 30, 2025 | Essential, Lab Industry Advisor, Operations-lca

However, integrated technologies must take into account data protection concerns

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LDT Appeal: Looking at the Legal Nuances Behind Potential FDA Actions Following Court Decision

LDT Appeal: Looking at the Legal Nuances Behind Potential FDA Actions Following Court Decision

by Scott Wallask | Apr 29, 2025 | CLIA-lca, Enforcement-lca, Enforcement-lir, Enforcement-nir, Essential, FDA-lir, FDA-nir, Lab Industry Advisor, LDTs-lir

Marginal LDT scenarios could be where the FDA focuses on next, a lawyer notes

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The Role of Advanced Molecular Diagnostics in Pathogen Detection

The Role of Advanced Molecular Diagnostics in Pathogen Detection

by Trevor Henderson, BSc(HK), MSc, PhD(c) | Apr 23, 2025 | Clinical Diagnostics Insider, Testing Trends-dtet

Explore how molecular diagnostics transform pathogen detection, providing faster, more accurate results compared to traditional testing methods

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How Advances in T-Cell Receptor Profiling Can Boost Early Cancer Diagnosis

How Advances in T-Cell Receptor Profiling Can Boost Early Cancer Diagnosis

by Brice Ezzouaouy | Apr 22, 2025 | Clinical Diagnostics Insider, Testing Trends-dtet

New developments in flow cytometry and molecular biology promise to improve the detection of rare cancers

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Diagnostics Pipeline: Savara Introduces Blood Test to Detect aPAP, a Rare Lung Disorder

Diagnostics Pipeline: Savara Introduces Blood Test to Detect aPAP, a Rare Lung Disorder

by Ron Shinkman | Apr 22, 2025 | Clinical Diagnostics Insider, Emerging Tests-dtet, Testing Trends-dtet

Savara’s ClearPath assay needs just a few drops of blood to test for aPAP, a condition that can be difficult and invasive to diagnose

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Success of Digital Pathology May Come Through its Ability to Handle Volumes

Success of Digital Pathology May Come Through its Ability to Handle Volumes

by Michael Schubert, PhD | Apr 21, 2025 | Clinical Diagnostics Insider, Testing Trends-dtet

Digital and computational pathology expert Donal O’Shea explores the role of emerging technologies in addressing workforce shortages

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Check Out These 5 Tips to Better Retain Clinical Lab Staff

Check Out These 5 Tips to Better Retain Clinical Lab Staff

by Tara Cepull, MA | Apr 4, 2025 | Employment-lca, Essential, Jobs-lir, Lab Industry Advisor

Options include establishing career trajectory plans and offering smooth onboarding for incoming laboratory scientists

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LDT Oversight Remains Under CLIA, for Now

LDT Oversight Remains Under CLIA, for Now

by Scott Wallask | Apr 4, 2025 | CLIA-nir, CMS-nir, Compliance-nir, Enforcement-nir, Essential, FDA-lca, FDA-lir, FDA-nir, Lab Industry Advisor, LDTs-lir

Judge rules that the FDA has ‘no authority’ to issue its rule governing laboratory-developed tests

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Routine Mass Spectrometry in Clinical Labs: A Competitive Advantage?

Routine Mass Spectrometry in Clinical Labs: A Competitive Advantage?

by Rachel Muenz | Mar 31, 2025 | Essential, Lab Industry Advisor, Operations-lca

How a new automated system bringing MS to routine lab testing could help set laboratories apart from their competitors

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FDA Watch: DOGE Changes at FDA Upend Approval Processes, Observers Say

FDA Watch: DOGE Changes at FDA Upend Approval Processes, Observers Say

by Ron Shinkman | Mar 28, 2025 | Essential, FDA-lca, Lab Industry Advisor

Pre-submission and Q-Submission meetings apparently have been halted, for now

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