domingo, 5 de octubre de 2014

Oversight of Laboratory Developed Tests: Impact on Genomics

Genomics|Update|Current

Genomics & Health Impact Update

Oversight of Laboratory Developed Tests: Impact on Genomics

a lab
What is a laboratory developed test?External Web Site Icon 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 LDT guidances to be available for public comment Oct. 3,External Web Site Icon Genome Web, Oct 1 [by free subscription only]
Regulatory changes raise troubling questions for genomic testingExternal Web Site Icon
Barbara J. Evans, et al.  Genet Med advance, September 25, 2014 
Regulation of genetic tests,External Web Site Icon information from the National Human Genome Research Institute

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