The Future Is Fluid
Liquid Biopsy Has Proven Its Mettle in the Fight against NSCLC and May Soon Also Be Standard of Care in Other Cancers
Genomics Brings Heavy Lifting to Immuno-Oncology
The Synergy of Two Burgeoning Fields Will Lead to Improved Precision Medicine
Singling Out RNA Biomarkers in Situ
ACD’s ISH Platform Achieves Single-Base Resolution and Retains Morphological Context
Microanalyte MDx Goes Mainstream
Nucleic Acid Analytes Are Reliable Sources of Data for Diagnostic Calculations
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Adroit Crafting of “Intended Use” Critical
Regulatory Fate of a New IVD May Well Depend on a Few Dozen Words
- In vitro diagnostic (IVD) devices are comprehensively regulated by the FDA. The FDA, however, does not regulate just the physical materials and software comprising an IVD. When developing a new assay, IVD companies tend to focus on key physical aspects: the composition of the assay, what it detects ...
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