Genomics|Update|Current ► Laboratory Developed Tests: New Approach to Oversight of Genomic Tests

Genomics|Update|Current

Laboratory Developed Tests: New Approach to Oversight of Genomic Tests

FDA takes steps to help ensure the reliability of certain diagnostic tests. Reinforces agency’s commitment to fostering personalized medicine, FDA, Jul 31

What is a laboratory developed test? A type of in vitro diagnostic test that is designed, manufactured and used within a single laboratory.They include a wide variety of analytes. This includes DNA which can be used to help diagnose a genetic disease or predisposition to disease

Curbing risk, not medical innovation, in Personalized Medicine, by Jeffrey Shuren, FDA Voice, Jul 31

NIH director's statement on FDA's proposed oversight of laboratory-developed tests, Jul 31

Long-awaited announcement from the FDA on LDTs 
Jennifer K. Wagner Genomics Law Report on August 1, 2014

Personalized medicine and companion diagnostics go hand-in-hand, FDA Consumer information, July 31, 2014