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LDT Appeal: Looking at the Legal Nuances Behind Potential FDA Actions Following Court Decision
Marginal LDT scenarios could be where the FDA focuses on next, a lawyer notes
The Role of Advanced Molecular Diagnostics in Pathogen Detection
Explore how molecular diagnostics transform pathogen detection, providing faster, more accurate results compared to traditional testing methods
How Advances in T-Cell Receptor Profiling Can Boost Early Cancer Diagnosis
New developments in flow cytometry and molecular biology promise to improve the detection of rare cancers
Diagnostics Pipeline: Savara Introduces Blood Test to Detect aPAP, a Rare Lung Disorder
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
Success of Digital Pathology May Come Through its Ability to Handle Volumes
Digital and computational pathology expert Donal O’Shea explores the role of emerging technologies in addressing workforce shortages
Check Out These 5 Tips to Better Retain Clinical Lab Staff
Options include establishing career trajectory plans and offering smooth onboarding for incoming laboratory scientists
LDT Oversight Remains Under CLIA, for Now
Judge rules that the FDA has ‘no authority’ to issue its rule governing laboratory-developed tests
Routine Mass Spectrometry in Clinical Labs: A Competitive Advantage?
How a new automated system bringing MS to routine lab testing could help set laboratories apart from their competitors
FDA Watch: DOGE Changes at FDA Upend Approval Processes, Observers Say
Pre-submission and Q-Submission meetings apparently have been halted, for now
Further Details to Note about Updated Clinical Lab Director Qualifications
Put into place late last year, the new rules place more emphasis on formal and continuing education requirements
