Laboratory Developed Tests (LDTs)
Learn more about laboratory developed tests (LDTs) - NILA Fact Sheet on LDTs (pdf)
NILA Advocacy and Information
August 23, 2021
NILA Comments on the VALID Act of 2021 (H.R.4128/S.2209)
Laboratory-Developed Tests (LDTs) offer patients the potential for preventing disease, obtaining early diagnoses, and receiving the most accurate and best course of treatment from their health care providers. Any regulatory process to oversee LDTs must appreciate the promise these tests hold without stifling innovation, while simultaneously ensuring patient safety and the accuracy, reliability, and reproducibility of LDTs. Two bills are before Congress to regulate LDTs: the VALID Act (FDA oversight) and the VITAL Act (CLIA oversight).
FDA LDT Homepage
Access background information, notices about public meetings, and archived webinars