Clinical Laboratory Reports in Molecular Pathology

CONTEXT: Molecular pathology is a rapidly growing area of laboratory medicine in which DNA and RNA are analyzed. The recent introduction of array technology has added another layer of complexity involving massive parallel analysis of multiple genes, transcripts, or proteins. OBJECTIVE: As molecular technologies are increasingly implemented in clinical settings, it is important to bring uniformity to the way that test results are reported. DATA SOURCES: The College of American Pathologists Molecular Pathology Resource Committee members summarize elements that are already common to virtually all molecular pathology reports, as set forth in the College of American Pathologists checklists used in the laboratory accreditation process. Consensus recommendations are proposed to improve report format and content, and areas of controversy are discussed. Resources are cited that promote use of proper gene nomenclature and that describe methods for reporting mutations, translocations, microsatellite instability, and other genetic alterations related to inherited disease, cancer, identity testing, microbiology, and pharmacogenetics. CONCLUSIONS: These resources and recommendations provide a framework for composing patient reports to convey molecular test results and their clinical significance to members of the health care team.