On March 1 Sen. Edward Kennedy (D-Mass.) introduced the Laboratory Test Improvement Act, which would put into place a comprehensive system of oversight for all laboratory-developed tests (LDTs), including genetic tests. Specifically, the bill grants explicit authority to the Food and Drug Administration (FDA) to regulate LDTs as medical devices. Currently only in vitro diagnostic devices, such as “test kits” or analyte specific reagents, are considered to be medical devices and therefore subject to regulation.

The bill specifies that most LDTs will be classified as Class II medical devices, although FDA can impose a more stringent Class III classification or less stringent Class I classification under certain conditions.

Additionally, all laboratories using LDTs would be required to register with FDA as medical device manufacturers, and to submit to FDA a list of tests offered by the laboratory, the intended uses of the tests, information on the tests’ analytical validity, and information on the tests’ clinical validity if they are intended for clinical use. Information submitted to FDA would be available to the public on the agency’s website.

If the submission is determined to be insufficient, FDA could require the laboratory test to undergo formal agency review. Laboratories that fail to undergo review of a test satisfactorily would be required to stop offering the test.

Laboratories offering tests directly to the public without a health care provider intermediary (DTC tests) would be required to submit their tests for agency review within 180 days of the bill’s enactment.

Laboratories using LDTs would be subject to other requirements applicable to medical device manufacturers, such as reporting of adverse events resulting from the use of LDTs. However, compliance with Clinical Laboratory Improvement Amendments of 1988 (CLIA) regulations would satisfy FDA’s Quality System Regulation requirements unless CLIA’s requirements are found to be inadequate for protecting the public’s health.

Finally, the bill directs the creation of a genetic testing specialty under CLIA.

The bill is cosponsored by Sen. Gordon Smith (R-Ore.).

Read the bill on http://www.thomas.gov (search for S 736 and select "bill number")

Read the issue brief "FDA Regulation of Genetic Tests"

Read the report Public Health at Risk: Failures in Oversight of Genetic Testing Laboratories

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