The cancer research question, analytic technique, or national ethical, legal, and social implications (ELSI) may dictate the use of 10% neutral buffered formalin fix, paraffin-embedded (FFPE). This decision may also be governed and governed by sample availability and access policies. Common tumors will likely be biobank. However, not all samples will have treatment and outcome data.
Although millions of FFPE archival materials are available in pathology departments around the world, there are still challenges to access them. Many research departments have questions about how the storage time of FFPE blocks affects quality. This is a crucial quality control step. Different tissue processing and fixation methods can lead to quality variations when samples are sourced from different pathology departments.
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Quality management is crucial for sample preparation and optimizing the quality extracts for proteomics research. Unpredictable failures including those not published are likely to be due to pre-analytical and unstable molecular targets, biological sampling factors that can be associated with certain tissue types, or poor quality management of pathology archives.
Pre-analytical phases standards are essential for molecular in vitro diagnostics for DNA, RNA, and, in particular, extracted protein. Reproducible results can only be achieved if the pre-analytical phases standards are adhered to. The future of medicine will be influenced by FFPE from pathology archives as there are more FFPE samples available.
Recognizing that FFPE samples can have greater quality variation than frozen samples, for a variety of reasons including variations in fixation, tissue processing, and other factors, it is important that FFPE results are validated provided that a cohort of frozen tissue samples are available.