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.
Lawmakers have asked four direct-to-consumer genetic testing companies to explain their privacy policies and security measures, according to Stat News.
The Trump Administration has proposed a plan to reorganize the federal government, the Washington Post reports.
In Science this week: genetic overlap among many psychiatric disorders, and more.
The Economist writes that an increasing number of scientific journals don't do peer review.