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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.
AstraZeneca has released its coronavirus vaccine trial protocol, according to the New York Times.
Time magazine looks into how liquid biopsies are changing cancer care.
According to the Guardian, more than 150 countries have signed on to a global SARS-CoV-2 vaccine plan.
In PNAS this week: similar muscle protein patterns across hypertrophic cardiomyopathy phenotypes, analysis of gene expression and brain anatomy in major depression, and more.