The US Food and Drug Administration (FDA) has initiated a pilot program to tackle concerns surrounding laboratory-developed tests (LDTs) in the field of oncology. LDTs, such as molecular and next-generation sequencing profiling tests, are created within individual laboratories to identify patients who could benefit from targeted therapies based on the genetic makeup of their tumors. These innovative tests are specific to each laboratory and play a crucial role in connecting rapidly advancing biomarker-targeted oncology treatments with the right patients. The year-long pilot program aims to address potential issues related to the accuracy and reliability of these diagnostic methods. This initiative by the FDA signifies their commitment to ensuring the safety and effectiveness of LDTs in oncology.

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