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 United Nations is to consider a ban on field testing gene drives at a meeting being held next week, Technology Review reports.
The Associated Press reports that gene-edited food may soon be for sale.
The US Department of Health and Human Services is beginning a series of meetings on human fetal tissue research, Stat News reports.
In Cell this week: epigenetic change linked to glioblastomas, rare and low-frequency variants contributing to multiple sclerosis risk, and more.