Preanalytics: The Imprecision in Precision Medicine

Recorded On: 10/15/2020

Registration Closed

Precision medicine is beset with an insidious imprecision: namely, the control of the preanalytical steps that impact the quality and integrity of patient biospecimens from which all molecular data is derived. All procedures, practices and environmental factors to which the biospecimen is subjected prior to a laboratory analysis are known as preanalytical factors. Artefactual alterations caused by these factors may skew the data from molecular analyses, render the analysis data uninterpretable or even preclude analysis altogether if the quality of specimen is severely compromised. As a result, patient care and safety may be affected¹and medical research dependent on patient samples may be compromised. Despite these issues, there is no requirement to control or document preanalytical variables in routine clinical practice in pathology with the single exception of the guidelines for breast cancer tissue jointly developed by the American Society of Clinical Oncology (ASCO) and the College of American Pathologists (CAP) and are included in the Accreditation Checklist of the CAP Laboratory Accreditation Program (LAP).

Recognizing the widespread and growing importance of molecular data derived from patient specimens, especially those from cancer patients, the Personalized Healthcare Committee (PHC) of the CAP established the Preanalytics for Precision Medicine Project Team (PPMPT) to develop a basic set of evidence-based recommendations for preanalytics for both tissue and blood specimens that could be implemented in routine pathology practice. In a 5-year effort, the PPMPT reviewed all relevant scientific data on the impact of preanalytical steps on nucleic acids and proteins in human tissue and blood specimens. This work informed a set of evidence-based practice recommendations for key preanalytical factors for tissue and for blood. If these recommendations are widely employed, the preanalytical factors having the strongest detrimental effect on the molecular integrity of patient biospecimens would be both controlled and documented and the fitness for molecular analysis of patient specimens would be assured. The PPMPT is currently revising the CAP LAP checklists to include requirements for control and documentation of key preanalytics. The revised checklists then will be approved by the relevant CAP committees and leadership and piloted for six months before becoming LAP requirements. It is envisioned that this historical step will elevate the molecular quality of patient specimens and assure their integrity for both clinical care and translational research.

Ref: Compton CC, Robb JA, Anderson MW, et al. Preanalytics and precision pathology: Pathology practices to ensure molecular integrity of cancer patient biospecimens for precision medicine. Arch Pathol Lab Med 2019; 143:1346-1363.

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Carolyn Compton, MD, PhD, FCAP

Professor, Life Sciences

Arizona State University

Carolyn Compton, MD, PhD is an academic pathologist specializing in gastrointestinal disease. She is a Professor of Life Sciences at Arizona State University, a Professor of Laboratory Medicine and Pathology at the Mayo Clinic School of Medicine, and a Professor of Pathology at the Johns Hopkins Medical Institutions. She is the Chief Medical Officer of both the National Biomarker Development Alliance and an Affiliated Scholar in the ASU Healthcare Delivery and Policy Program. Since February 2020, she has been the Medical Director of the ASU Biodesign Clinical Testing Laboratory. She is the Chair of the Precision Medicine Core of the AJCC and the Chair of the Preanalytics for Precision Medicine Project Team of the College of American Pathologists. She serves as the editor-in-chief of the Nature review journal Current Pathobiology Reports. She is a former Professor of Pathology at Harvard Medical School, Chief of Gastrointestinal Pathology at Massachusetts General Hospital, and Pathologist-in-Chief of the Boston Shriners Children’s Hospital. More recently she has served as the CEO and President of the Critical Path Institute (2012), the Director of the Office of Biorepositories and Biospecimen Research and the Director of the Innovative Molecular Analysis Technologies program at the National Cancer Institute (2005-2011), and the Strathcona Professor and Chair of the Department of Pathology at McGill University and Pathologist-in-Chief of the McGill University Health Center.