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

Genomics|Update|Current

Oversight of Laboratory Developed Tests: Impact on Genomics?

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

Check out our Laboratory Developed Tests update page for additional information and links