FDA’s Proposal to Regulate Laboratory Developed Tests Vulnerable to a “Major Questions” Challenge

January 26, 2024By: Jeffrey N. Gibbs & Steven J Gonzalez Download PDF

Laboratory Developed Tests (LDTs), which are diagnostic tests developed, manufactured, and used within a single laboratory, play an essential role in health care in the United States. For example, LDTs are routinely used in genetic screening of couples considering having a child, prenatal testing of the fetus, newborn screening, testing for rare diseases and conditions, and pharmacogenomic testing to determine whether a particular drug is suitable for a patient.

The continued availability of these tests, though, is threatened by a proposed regulation issued by the Food and Drug Administration (FDA). On October 3, 2023, FDA proposed that LDTs be regulated in the same way as in vitro diagnostic (IVD) tests manufactured by companies and then shipped to customers (the “Proposed Rule”).

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