Abstract
Precision tissue diagnostics rely on high quality input specimens so that assay results are not affected by artifact, but advances in collection and processing of tissue specimens have lagged behind innovations in diagnostic assay development. Therefore, we have designed and evaluated a novel surgical tissue collection device that maintains and monitors sample temperature and motion throughout transport so that the major preanalytical variable of tissue temperature can be controlled and measured. This device, in combination with an improved cold–hot tissue fixation protocol affords optimal biomarker preservation in less overall time, thereby simultaneously improving diagnostic quality and turnaround time. We collected 50 primary and metastatic liver tumors using a novel transport device. Tissue was fixed using a rapid cold–hot fixation protocol and immunohistochemical assays were used to assess the performance of the device, in comparison to control tissue preserved using standard clinical fixation protocol. Two pathologists evaluated the IHC studies in a blinded fashion to determine the immunophenotype of each tumor. The observed IHC staining intensities and the clinical impressions of the immunophenotypes did not differ between tissue collected with the novel device and control tissue, while improvements in processing time were achieved. The novel cold transport device and rapid fixation protocol can be successfully and safely combined and used to monitor specimen conditions, thus preserving the diagnostic utility of specimens and improving the overall turn-around time of the diagnostic process.
Highlights
Modern cancer therapeutics target specific proteins and pathways in biochemical networks, forming the backbone of ‘‘Precision Medicine.’’ Effective precision medicine relies on clinical diagnostic tests to guide the choice of specific therapeutics, and such tests must be performed on high-quality tissues in which the pathophysiologic derangement responsible for the disease in question are preserved in a state that can be measured accurately (Twomey et al 2017)
There is evidence that cold formalin fixation improves the preservation of biochemical markers especially within signaling networks such as phosphoproteins (Chafin et al 2013; Theiss et al 2014), and that cold formalin fixation has been shown to aid in the preservation of nucleic acids (Bussolati et al 2011), but ideal fixation conditions for all tissue assays have not yet been established, and the lack of current fixation monitoring technology means that even if optimal tissue fixation conditions are established for specific assays, it may be difficult to ensure that every single clinical specimens receives this optimal treatment
Most tissue samples were loaded onto the tissue processor to complete the cold fixation step before 2-h incubation was complete, meaning that the cold formalin fixation step was completed on the tissue processor followed by a 2 h fixation in hot formalin (45 °C)
Summary
Modern cancer therapeutics target specific proteins and pathways in biochemical networks, forming the backbone of ‘‘Precision Medicine.’’ Effective precision medicine relies on clinical diagnostic tests to guide the choice of specific therapeutics, and such tests must be performed on high-quality tissues in which the pathophysiologic derangement responsible for the disease in question are preserved in a state that can be measured accurately (Twomey et al 2017). There is evidence that cold formalin fixation improves the preservation of biochemical markers especially within signaling networks such as phosphoproteins (Chafin et al 2013; Theiss et al 2014), and that cold formalin fixation has been shown to aid in the preservation of nucleic acids (Bussolati et al 2011), but ideal fixation conditions for all tissue assays have not yet been established, and the lack of current fixation monitoring technology means that even if optimal tissue fixation conditions are established for specific assays, it may be difficult to ensure that every single clinical specimens receives this optimal treatment.
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