Genomics|Update|Current ► Oversight of Laboratory Developed Tests: Impact on Genomics

Genomics|Update|Current

Oversight of Laboratory Developed Tests: Impact on Genomics

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

FDA Draft Guidance for Industry, Food and Drug Administration Staff, and Clinical Laboratories - Framework for Regulatory Oversight of Laboratory Developed Tests (LDTs),  [PDF 312.49 KB] October 1, 2014

FDA draft LDT guidances to be available for public comment Oct. 3, Genome Web, Oct 1 [by free subscription only]

Big changes for molecular diagnostics as FDA moves on lab developed tests, by Aaron Krol, Bio IT World,  Sep 23

Regulatory changes raise troubling questions for genomic testing
Barbara J. Evans, et al.  Genet Med advance, September 25, 2014 

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

Regulation of genetic tests, information from the National Human Genome Research Institute