To address concerns about laboratory-developed tests( LDTs ), the US Food and Drug Administration ( FDA ) recently announced the start of a year-long pilot program regarding diagnostic methods within oncology. In order to choose patients for approved therapies that are tailored to the genetic profile of their tumor, molecular and next-generation sequencing profiling tests are frequently created and produced in a single laboratory. These diagnostic LDTs are cutting-edge and particular to that lab, and they frequently serve as the only way to match the patients who can benefit from the rapidly evolving biomarker-targeted oncology therapies.