LDTs
Adaptive Cofounder and Chief Scientific Officer Harlan Robins compared the launch of the test to the unveiling of the Tesla Roadster electric sports car.
NanoString Technologies, OHSU Partner on Breast Cancer Spatial Protein Profiling Assay Development
A new GeoMx Digital Spatial Profiler assay will have up to 30 protein targets and will be validated for potential use as a laboratory-developed test.
Laboratory Stakeholders Weigh In On Biden Administration Priorities
The COVID-19 pandemic is the highest priority for most, but laboratory organizations are also looking ahead with longer-term goals for the new presidency.
FDA Joins PGx Collaborative Community but Effect on Field is Unclear
The community is poised to be the primary channel for stakeholders to communicate PGx concerns with FDA, but it is unclear if all stakeholders will participate.
Stakeholders Scramble to Predict Impact of HHS Move Limiting FDA Ability to Regulate LDTs
The move raises questions about what precisely is an LDT outside of FDA jurisdiction and heightens concerns that poorly validated tests will enter the market and endanger public health.