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- Oral Arguments for LDT Lawsuit Happening on February 19
Oral arguments will be heard in a US District Court in Eastern Texas over the federal oversight of laboratory-developed tests (LDTs) on Wednesday, February 19.
Lawsuits against the federal oversight of LDTs were filed by the American Clinical Laboratory Association (ACLA) and the Association for Molecular Pathology (AMP) and later consolidated in September 2024. In October, the CAP filed an amicus brief urging the court to vacate the Food and Drug Administration (FDA) LDT regulation for several reasons, including the ultimate impact on patient access to these critical diagnostic tests and the agency's failure to adequately justify the rule's unsustainable costs that will hinder the development of LDTs. Several groups have filed amicus briefs supporting the FDA, and the agency filed its closing brief on December 23, 2024.
The CAP will provide its members with updates after the hearing concludes.