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- Court Schedules Oral Arguments for LDT Lawsuit on February 19
A motion has been granted in a US District Court in Eastern Texas to hear oral arguments over the federal oversight of laboratory-developed tests (LDTs) on February 19.
Lawsuits against the federal oversight of LDTs were consolidated and filed by the American Clinical Laboratory Association (ACLA) and the Association for Molecular Pathology (AMP) on September 9, 2024. In October, the CAP filed an amicus brief urging the court to vacate the FDA regulation for several reasons, including the ultimate impact on patient access to these critically important diagnostic tests and the agency's failure to adequately justify the rule's unsustainable costs that will hinder the development of LDTs.
The Food and Drug Administration (FDA) filed its closing brief on December 23, 2024, in the federal court case over the regulation of LDTs.
The CAP will update members on the final decision as information becomes available.