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Genomics|Features|Laboratory Developed Tests

Laboratory Developed Tests

Oversight of Laboratory Developed Tests: Impact on Genomics? April 3, 2015

The regulation debate- is government oversight of laboratory-developed tests needed? By J Guinto, Genome Magazine, Spring 2015

FDA regulation of laboratory-developed diagnostic tests:  Protect the public, advance the science.
Joshua Sharfstein, JAMA, January 5, 2015

Genetic testing and FDA regulation:  Overregulation threatens the emergence of genomic medicine.
Evans J et al. JAMA January 5, 2015

Q&A: FDA's Alberto Gutierrez fields questions on evolving LDT, CDx regulations
Ray T. GenomeWeb, Dec 30, 2014.

Opinions divided on proposed FDA LDT regulations - The debate on laboratory developed tests boils down to whether clinical labs should come under the agency’s control, by Chris Anderson, GEN & Biotechnology News, Jan 7, 2015

Oversight of Laboratory Developed Tests: Impact on Genomics - October 2, 2014

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FDA Draft Guidance for Industry, Food and Drug Administration Staff, and Clinical Laboratories - Framework for Regulatory Oversight of Laboratory Developed Tests (LDTs),  [PDF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