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.
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.
Genentech will use Adaptive's ClonoSeq assay for MRD testing in a CLL study. Adaptive will receive upfront and sample testing payments of undisclosed amounts.
Lexent's NGS assay for monitoring response to treatment and minimal residual disease for solid tumors will eventually run on the Illumina NextSeq 550Dx.
