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Arch Pathol Lab Med. 2019 Jul 22. doi: 10.5858/arpa.2019-0009-SA. [Epub ahead of print]

Preanalytics and Precision Pathology: Pathology Practices to Ensure Molecular Integrity of Cancer Patient Biospecimens for Precision Medicine.

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From School of Life Sciences, Arizona State University and Mayo Clinic School of Medicine, Scottsdale (Dr Compton); Consulting Pathologist, Boca Raton, Florida (Dr Robb); Versiti Diagnostic Laboratories, Milwaukee, Wisconsin (Dr Anderson); Molecular Pathology and Genomics, Swedish Cancer Institute, Seattle, Washington (Dr Berry); Anatomic Pathology, Grady Health System, Atlanta, Georgia (Dr Birdsong); Advanced Genomic Services, Ambry Genetics, Aliso Viejo, California (Dr Bloom); Gynecologic & Breast Pathology, Joint Pathology Center, Silver Spring, Maryland (Dr Branton); the Department of Pathology, Brigham and Women's Hospital, Boston, Massachusetts (Dr Crothers); the Department of Pathology and Microbiology, University of Nebraska Medical Center, Omaha (Dr Cushman-Vokoun); IHC-ISH Laboratory and Breast Subspecialty Service, University of Rochester Medical Center, Rochester, New York (Dr Hicks); the Department of Hematopathology, The University of Texas MD Anderson Cancer Center, Houston (Dr Khoury); the Department of Pathology and Laboratory Medicine, Northwell Health, New Hyde Park, New York (Dr Laser); the Department of Pathology, University of Colorado, Aurora (Dr Marshall); the Department of Pathology, Newton-Wellesley Hospital, Newton, Massachusetts (Dr Misialek); the Department of Pathology, Walter Reed National Military Medical Center, Bethesda, Maryland (Dr Natale); the Department of Pathology and Laboratory Medicine, Roswell Park Comprehensive Cancer Center, Buffalo, New York (Dr Nowak); the Department of Pathology, Children's Hospitals and Clinics, Minneapolis, Minnesota (Dr Olson); the Department of Pathology, Washington University School of Medicine, St. Louis, Missouri (Dr Pfeifer); Lilly Research Labs, Eli Lilly and Company, Lilly Corporate Center, Indianapolis, Indiana (Dr Schade); the Department of Medical and Molecular Genetics, Indiana University School of Medicine, Indianapolis (Dr Vance); Medical & Scientific Affairs, Roche Tissue Diagnostics, Tucson, Arizona (Dr Walk); and Special Hematology MMC, University of Minnesota Medical Center, Minneapolis (Dr Yohe).


Biospecimens acquired during routine medical practice are the primary sources of molecular information about patients and their diseases that underlies precision medicine and translational research. In cancer care, molecular analysis of biospecimens is especially common because it often determines treatment choices and may be used to monitor therapy in real time. However, patient specimens are collected, handled, and processed according to routine clinical procedures during which they are subjected to factors that may alter their molecular quality and composition. Such artefactual alteration may skew data from molecular analyses, render analysis data uninterpretable, or even preclude analysis altogether if the integrity of specimen is severely compromised. As a result, patient care and safety may be affected, and medical research dependent on patient samples may be compromised. Despite these issues, there is currently no requirement to control or record preanalytical variables in clinical practice with the single exception of breast cancer tissue handled according to the guideline jointly developed by the American Society of Clinical Oncology and College of American Pathologists (CAP) and enforced through the CAP Laboratory Accreditation Program. Recognizing the importance of molecular data derived from patient specimens, the CAP Personalized Healthcare Committee established the Preanalytics for Precision Medicine Project Team to develop a basic set of evidence-based recommendations for key preanalytics for tissue and blood specimens. If used for biospecimens from patients, these preanalytical recommendations would ensure the fitness of those specimens for molecular analysis and help to assure the quality and reliability of the analysis data.


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