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

被引:87
作者
Compton, Carolyn C. [1 ,2 ]
Robb, James A.
Anderson, Matthew W. [3 ]
Berry, Anna B. [4 ]
Birdsong, George G. [5 ]
Bloom, Kenneth J. [6 ]
Branton, Philip A. [7 ]
Crothers, Jessica W. [8 ]
Cushman-Vokoun, Allison M. [9 ]
Hicks, David G. [10 ,11 ]
Khoury, Joseph D. [12 ]
Laser, Jordan [13 ]
Marshall, Carrie B. [14 ]
Misialek, Michael J. [15 ]
Natale, Kristen E. [16 ]
Nowak, Jan Anthony [17 ]
Olson, Damon [18 ]
Pfeifer, John D. [19 ]
Schade, Andrew [20 ]
Vance, Gail H. [21 ]
Walk, Eric E. [22 ]
Yohe, Sophia Louise [23 ]
机构
[1] Arizona State Univ, Sch Life Sci, 1475 N Scottsdale Rd,Suite 361D, Scottsdale, AZ 85257 USA
[2] Mayo Clin, Sch Med, Scottsdale, AZ USA
[3] Versiti Diagnost Labs, Milwaukee, WI USA
[4] Swedish Canc Inst, Mol Pathol & Genom, Seattle, WA USA
[5] Grady Hlth Syst, Anat Pathol, Atlanta, GA USA
[6] Ambry Genet, Adv Genom Serv, Aliso Viejo, CA USA
[7] Joint Pathol Ctr, Gynecol & Breast Pathol, Silver Spring, MD USA
[8] Brigham & Womens Hosp, Dept Pathol, 75 Francis St, Boston, MA 02115 USA
[9] Univ Nebraska, Med Ctr, Dept Pathol & Microbiol, Omaha, NE USA
[10] Univ Rochester, Med Ctr, IHC ISH Lab, New York, NY USA
[11] Univ Rochester, Med Ctr, Breast Subspecialty Serv, New York, NY USA
[12] Univ Texas MD Anderson Canc Ctr, Dept Hematopathol, Houston, TX 77030 USA
[13] Northwell Hlth, Dept Pathol & Lab Med, New Hyde Pk, NY USA
[14] Univ Colorado, Dept Pathol, Aurora, CO USA
[15] Newton Wellesley Hosp, Dept Pathol, Newton, MA USA
[16] Walter Reed Natl Mil Med Ctr, Dept Pathol, Bethesda, MD USA
[17] Roswell Park Comprehens Canc Ctr, Dept Pathol & Lab Med, Buffalo, NY USA
[18] Childrens Hosp & Clin, Dept Pathol, Minneapolis, MN USA
[19] Washington Univ, Sch Med, Dept Pathol, St Louis, MO 63110 USA
[20] Eli Lilly & Co, Lilly Corp Ctr, Lilly Res Labs, Indianapolis, IN 46285 USA
[21] Indiana Univ, Sch Med, Dept Med & Mol Genet, Indianapolis, IN 46202 USA
[22] Roche Tissue Diagnost, Med & Sci Affairs, Tucson, AZ USA
[23] Univ Minnesota, Med Ctr, Special Hematol MMC, Minneapolis, MN 55455 USA
关键词
IN-SITU HYBRIDIZATION; PARAFFIN-EMBEDDED TISSUES; POLYMERASE-CHAIN-REACTION; OF-AMERICAN-PATHOLOGISTS; COLD ISCHEMIA TIME; KINASE INHIBITORS GUIDELINE; CIRCULATING TUMOR-CELLS; BLOOD COLLECTION TUBES; FORMALIN FIXATION; ESTROGEN-RECEPTOR;
D O I
10.5858/arpa.2019-0009-SA
中图分类号
R446 [实验室诊断]; R-33 [实验医学、医学实验];
学科分类号
1001 ;
摘要
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 a 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.
引用
收藏
页码:1346 / 1363
页数:18
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