Bruce Parker and Casey Bryant published "Arguments for and Against FDA Regulation of Laboratory Developed Tests and the Effect on Litigation" in the September 2018 edition of DRI's For the Defense. Here is an excerpt:
In recent years, personalized medicine has become more attainable through scientific advances, especially in the field of genomics. Using genetic-mapping techniques, laboratories have developed tests that are reported to identify genetic markers for diseases such as cancer and diabetes. Television commercials advertise genetic tests that purportedly allow you to trace your ancestry back hundreds of years. While home genetic testing is undoubtedly an entertaining family project for some, physicians rely on molecular genetic testing for diagnostic and therapeutic decisions. Consequently, it is imperative that the tests have high degrees of sensitivity, specificity, and accuracy. These concerns were articulated in "The Public Health Evidence for FDA Oversight of Laboratory Developed Tests: 20 Case Studies," a U.S. Food and Drug Administration (FDA) publication issued on November 16, 2015.