Laboratory Developed Tests

Laboratory Developed Tests (LDTs) are laboratory tests that hospitals, academic, and clinical laboratories develop as testing services according to their own procedures. These tests are often created in response to unmet clinical needs, and are commonly used for early and precise diagnosis, monitoring, and guiding patient treatment. LDTs are also used to diagnose and assess…

Laboratory Developed Tests (LDTs) are laboratory tests that hospitals, academic, and clinical laboratories develop as testing services according to their own procedures. These tests are often created in response to unmet clinical needs, and are commonly used for early and precise diagnosis, monitoring, and guiding patient treatment. LDTs are also used to diagnose and assess diseases and disorders for which no FDA-authorized test-kit currently exists, such as rare and emergent diseases, or those with small patient populations. Nearly all diagnostic tests and FDA-approved test kits begin as LDTs, and in many cases, LDTs represent the standard of care. The ability of laboratories to develop custom diagnostic tests has been critical to the growth of personalized medicine and keeping pace with the changing face of disease to best serve patients and clinicians.

Since 1988, the laboratories performing LDTs have been highly regulated by a comprehensive federal statutory framework under the Clinical Laboratory Improvement Amendments (CLIA), which requires continuous monitoring to ensure validity and reliability of LDTs. For the last few years, however, the Food and Drug Administration (FDA) has expressed its intent to regulate LDTs as medical devices, despite the fact that they are services, not products, and aren’t sold commercially.

FDA regulation of LDTs would be contrary to the public health. Numerous critical tests are only available as LDTs, including many “gold standard” DNA sequencing assays, newborn screening tests, and tests for rare diseases. If FDA were to require clearance or approval for LDTs, laboratories may be unable to continue offering them. Some testing currently performed at laboratories as LDTs will never generate the financial returns to justify the costs of obtaining FDA clearance or approval. Patients served by these tests would be left with no testing options. Similarly, critical testing would be unavailable in the “lag time” between development of new tests and FDA authorizing them, and subsequent improvements on existing tests would slow significantly under the rigid, inflexible, and duplicative FDA regulatory scheme.

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