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.
In Science this week: deletion of one microRNA allows pluripotent stem cells to form embryonic and non-embryonic lineages, and more.
Arizona is planning to sue Theranos for "deceptive acts" and misrepresentations of its "capabilities and operation."
If confirmed as Department of Health and Human Services Secretary, Tom Price says he will divest himself of certain holdings, according to Stat News.
Oliver Smithies, who won the Nobel Prize in 2007, has died, the New York Times reports.