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Updated: May 31, 2026
Biobank for Translational Medicine: Standard Operating Procedures for Optimal Sample Management
Published on: November 30, 2022
The challenge and importance of standardizing pre-analytical variables in surgical pathology specimens for clinical
1Department of Pathology and Laboratory Medicine, University of Rochester Medical Center, 601 Elmwood Avenue, Box 626, Rochester, NY 14642, USA. David_hicks@urmc.rochester.edu
Abstract:
The introduction of targeted cancer therapies into clinical practice, in which patients are selected for novel treatments based on results of companion molecular testing of their tumor specimens, has created significant new challenges for the surgical pathology laboratory. These include standardization of tissue handling and sample preparation with accurate documentation to ensure optimal quality of clinical samples to reduce the risk of errors in molecular biology tests. The assay of tumor tissues for biomarkers that can provide predictive data for prognosis or treatment should enable selection of the most appropriate therapies (Yaziji et al. 2008, Hicks and Kulkarni 2008). Major advances have been made in the ability to profile clinical samples for research at the DNA, RNA and protein levels. To translate this new information into the clinical setting, however, the quality of the starting material, in this case the tumor tissue, determines the accuracy and reliability of companion diagnostic assay results and therefore optimal therapeutic strategies. Inaccurate results owing to compromised tissue quality can lead to false positive or false negative results with therapeutic consequences that can harm patients and affect their eventual outcome.
Insights
Companion molecular testing for targeted cancer therapies presents challenges for pathology labs. Ensuring high-quality tumor tissue is crucial for accurate diagnostic results and effective patient treatment strategies.
Area of Science:
- Oncology
- Pathology
- Molecular Diagnostics
Background:
- Targeted cancer therapies require companion molecular testing of tumor specimens for patient selection.
- This necessitates standardized tissue handling and sample preparation in surgical pathology labs.
- Advances in molecular profiling (DNA, RNA, protein) require high-quality starting material for clinical translation.
Purpose of the Study:
- To highlight the challenges in surgical pathology laboratories introduced by companion molecular testing.
- To emphasize the critical role of tumor tissue quality in companion diagnostic assay accuracy.
- To underscore the impact of tissue quality on patient outcomes and therapeutic strategies.
Main Methods:
- Review of current practices in surgical pathology for molecular testing.
- Analysis of the impact of tissue handling and sample preparation on molecular assay reliability.
- Discussion of the link between tissue quality and the accuracy of predictive biomarker data.
Main Results:
- Standardization of tissue handling and documentation is essential to reduce errors in molecular tests.
- Compromised tissue quality can lead to inaccurate diagnostic results (false positives/negatives).
- Accurate companion diagnostic assays are vital for selecting appropriate, effective cancer therapies.
Conclusions:
- Optimal quality of tumor tissue is paramount for reliable companion diagnostic testing.
- Ensuring tissue integrity is critical to avoid therapeutic consequences and improve patient outcomes.
- Surgical pathology laboratories face new challenges in meeting the demands of molecularly guided cancer treatment.
