As the U.S. health care system is poised to further embrace personalized medicine, CDRH Director Jeffrey Shuren says it is critical for FDA to use its authority to regulate lab developed tests (LDT), such as those for genotype testing, to ensure they are reliable.
Speaking before a Senate Health, Education, Labor and Pensions Committee hearing on Precision Medicine, lawmakers appeared shocked when Shuren told them there are tests on the market the agency knows...