The agency could decide that array-based cytogenetic assays require 510(k) clearance or pre-market approval, a shift that could have a broad impact on the use of arrays in clinical cytogenetics.
OIVD Director Alberto Gutierrez acknowledged that the dual regulatory pathway — through CMS under the Clinical Laboratory Improvement Amendments and through the FDA — creates "an uneven playing field" for diagnostics developers.
The partially reinstated US travel ban leaves space for uncertainty for researchers, Nature News says.
Researchers find a number of traits differ by sex and could affect mouse model studies, according to Reuters.
Tweaking the skin microbiome could help address some skin conditions, the New York Times reports.
In PNAS this week: DNA methylation profiles of tumor tissue, gene dynamics in prokaryotes, and more.