Monthly Archives: July 2011

FDA’s Proposed Policy in Companion Diagnostics

On July 12, 2011, the FDA released a new draft guidance on the development and review of companion diagnostics (CDx). I would encourage anyone working in anatomic pathology to review the draft, as it will have widespread impact on digital pathology companies, antibody providers, and anatomic pathologists in both private practices and large reference laboratories. The [...]

Virtual peer review of primate studies in Asia

In a collaboration with EPL, the leading GLP pathology peer review organization, Flagship Biosciences presented continued work at the Society of Toxicology Pathology meeting in Denver, Colorado in June 2011 on virtual peer review. The Virtual Imaging in Peer Review or VIPER was a consortium of multiple pharma companies started in 2010 to evaluate international [...]