“As earlier threatened, the Food and Drug Administration (FDA) has just issued new rules that will significantly slow down the development of new diagnostic tests. Specifically, the agency requires that all laboratory-developed tests (LDTs) be submitted to its regulators before the tests can be offered to patients and physicians. As I explained earlier, LDTs are in vitro diagnostic (IVD) tests for clinical use that are designed, manufactured, and performed by individual laboratories. They can diagnose illnesses and guide treatments by detecting relevant biomarkers in saliva, blood, or tissues; the tests can identify small molecules, proteins, RNA, DNA, cells, and pathogens. For example, some assess the risks of developing Alzheimer’s disease or guide the treatment of breast cancer.”
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” “Laboratory developed testing services are not medical devices and subjecting them to medical device regulation will harm patient access to needed testing and compromise innovations that drive personalized medicine,” said American Clinical Laboratory Association President Susan Van Meter in a statement. “The rule will limit access to scores of critical tests, increase health care costs, and undermine innovation in new diagnostics.””