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
Long-awaited announcement from the FDA on LDTs ![External Web Site Icon External Web Site Icon](https://lh3.googleusercontent.com/blogger_img_proxy/AEn0k_vOkHr9hY24SDMzkVM2iUOXfIhqzUiqUlvYrAtOFFk0w5uVVJbXYGfx7VBrBflBpn92jbUG7WOCJSMPV2leo-6k7u6JZ0omR8iphwnji-lXPZwAaFf8SAAS=s0-d)
Jennifer K. Wagner Genomics Law Report on August 1, 2014
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
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