Laboratory Developed Tests

Printer-friendly versionSend by emailPDF version

Legislative History:

Senators Ted Kennedy (D-MA), Chairman of the Senate Health, Education, Labor and Pensions (HELP) Committee, and Senator Barack Obama (D-IL), member of the Senate HELP Committee, have introduced in the first session of the 110th Congress legislation that would strengthen oversight of laboratory developed tests (LDTs). ACLA opposed Senator Kennedy’s legislation (S.736) because of concerns that it would stifle innovation for patient care and supported Senator Obama’s legislation (S.976). ACLA successfully signed on with 25 other organizations asking Senator Kennedy to allow more time for stakeholder discussion on his bill. ACLA worked with Senator Obama's office to include a provision in legislation to reauthorize FDA user fee programs that would require HHS to fund an Institute of Medicine study on the oversight of genetic tests unless the Secretary’s Advisory Committee on Genetics Health and Society (SACGHS) completed their report on genetic test oversight. That bill was passed by Congress and signed by the President in October, 2007. SACGHS did complete their report in February 2008. The report identified a gap in oversight related to clinical validity and their belief that it is imperative to close this gap as expeditiously as possible. The report further called for a genetic test registry to be informed by a stakeholders meeting in 2008 to assist in identifying the lead HHS agency and in determining the data elements to be included in such a test registry.

Current Position:

From a ACLA sponsored September 2010 stakeholder meeting with FDA, there was a strong consensus from the laboratory industry that an enhanced CLIA is the right course of action for LDT oversight.  Applying any FDA regulatory approach to LDTs is redundant, will stifle innovation and will require additional government funds for the FDA.

A CLIA approach will avoid those consequences and can be done at no cost to the government.   A modernized CLIA will facilitate innovation, promote economic growth and provide better patient access to these diagnostics.   Specifically,

•         The current oversight system for LDTs needs to be modernized and LDTs should be regulatory distinct from   medical device regulation.  CLIA should be responsible for the validity of all LDTs.  FDA should maintain responsibility for     in-vitro diagnostic (IVD) test kits with streamlined oversight.                                                                                           
•          A new requirement should be place on entities offering DTC tests.  Clinical laboratories are regulated under CLIA but, to date, CLIA requirements have not been enforced for non-clinical laboratory DTC Test Offering Entities.   That significant gap should be closed by enforcing CLIA clinical validity requirements on DTC Test Offering Entities.