The Regulation of Companion Diagnostics: Current Status and Updates
Companion diagnostics for personalized medicine is the most important emerging trend in the IVD industry today. In July, FDA released its draft guidance document regarding companion diagnostics, which offers the agency's current thinking on this area. In an effort to provide further clarity on this matter, the editors of IVD Technology have put together a special Webcast on the regulation of companion diagnostics.
Among the American IVD manufacturers working to make personalized medicine a day-to-day reality in healthcare, none appears busier than Ventana Medical Systems in Tucson, Arizona.
Doing more with less is a goal of manufacturing across all industries, including companies making IVDs. Manufacturers want to make high-quality products in large volumes but with simpler,...