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.
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.
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.
HHS Says FDA Can't Regulate Lab-Developed Tests Without Notice, Comment Rulemaking
The action will immediately allow labs to offer SARS-CoV-2 LDTs without requiring EUA, and make it voluntary for labs to take LDTs through FDA premarket review.