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Peer-Reviewed Publication
Genet Med2025;27(6):101391.June 1, 2025Journal Article

A primer on regulation of laboratory-developed testing procedures: A points to consider statement of the American College of Medical Genetics and Genomics (ACMG).

Marco L Leung1, Raymond C Caylor2, Olivia D'Annibale3, Michelle McClure4, TaraChandra Narumanchi5, Laura M Sack6, Sarah T South7, 4
1The Steve and Cindy Rasmussen Institute for Genomic Medicine, Nationwide Children's Hospital, Columbus, OH; Departments of Pathology and Pediatrics, The Ohio State University College of Medicine, Columbus, OH.
2Greenwood Genetic Center, Greenwood, SC.
3Clinical Biochemical Genetics Fellow, University of Colorado Anschutz Medical Campus, Aurora, CO.
4American College of Medical Genetics and Genomics, Bethesda, MD.
5Chicagi, LLC, Memphis, TN.
6Fulgent Genetics, El Monte, CA.
7Quest Diagnostics, Secaucus, NJ.

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