Lexent's NGS assay for monitoring response to treatment and minimal residual disease for solid tumors will eventually run on the Illumina NextSeq 550Dx.
While some groups have communicated their concerns directly to the agency, stakeholders have also formed a new coalition to publicly take issue with FDA's actions.
The Columbia Solid Tumor Panel, a custom NGS panel from Pillar Biosciences, will be used at CUMC's Laboratory of Personalized Genomic Medicine.
How labs — including those that are part of other healthcare systems — offering PGx testing will react to Inova's decision to not engage with the FDA remains to be seen.
Pharmacogenetics and legal experts took particular issue with the agency's suggestion that "established" drug/gene relationships are found only in FDA-approved drug labels.
The discussion draft includes the regulatory proposals, including precertification, the FDA provided to legislators in a technical assistance document.
At the Personalized Medicine Conference this week, stakeholders historically at odds over lab test regulation said it is up to Congress to resolve the issue.
At his FDA Law Blog, Jeffrey Gibbs discusses FDA's technical assistance for the draft Diagnostic Accuracy and Innovation Act.
The agency's regulatory plan differs in key areas from a draft of the Diagnostic Accuracy and Innovation Act that had shored up lab industry support.
Seventeen organizations don't support the Diagnostic Accuracy and Innovation Act as written and would like lawmakers to advance a CLIA-centric framework.
Researchers are sampling the wild relatives of modern crops to try to preserve genetic diversity, NPR reports.
MIT's Search for Extraterrestrial Genomes is developing sequencing tools to use to try to detect whether there is any life on Mars, Quartz reports.
Undark reports on a bill introduced this year to the US House of Representatives to strengthen scientific integrity.
In Genome Research this week: post-zygotic mutations in diabetes development, single-cell RNA sequencing study of aging, and more.