Laboratory-developed tests (LDTs) are widely used and include routine testing such as pap smears. LDTs can be simple or complex. Faulty tests can lead to patients receiving inappropriate and potentially harmful treatment, incorrect diagnosis or failing to receive potentially beneficial treatment. The Food and Drug Administration has recently announced its plan to regulate medical diagnostic laboratory tests. The FDA has identified problems with several high-risk LDTs such as – claims that are not adequately supported with evidence; lack of appropriate controls yielding erroneous results; and falsification of data. The agency contends that regulating these tests will protect patients at a time when the genetic testing market is undergoing rapid growth.

Lab Developed Tests

However, in the two day FDA workshop that started on January 8, critics have viewed it as an unnecessary step that could potentially stifle innovation in future testing models. The American Hospital Association, the American Medical Association and the American Clinical Laboratory Association opposed the proposal saying that the regulation will limit the new and clinically pioneering advances in genetic testing.

Last year, the agency developed a risk-based framework to regulate laboratory-developed tests, which was regulated by the CMS as the result of a law passed in the 1980s over concerns about the quality of pap smears. The agency protects public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices.

The American Society for Clinical Oncology (ASCO) submitted its comments on January 5, strongly supporting the Food and Drug Administration’s proposed risk-based approach to regulate laboratory developed tests (LDTs).

JAMA, in support of the proposal argues that the FDA is right and regulation will mean laboratories will have to back up claims with research provided during the approval process rather than marketing a test with unverified claims.

FDA currently regulates diagnostic tests developed by manufacturers that have also argued in favor of the FDA proposal.