Economical and Organizational Impact of Adopting Different in Situ Hybridization Technologies to Assess HER2 Gene Amplification in Breast Cancer

Abstract

Human epidermal growth factor receptor 2 (HER2) status identification is established by immunohistochemistry and in situ hybridisation (ISH). Silver in situ hybridisation (SISH) is an alternative technique to the fluorescence in situ hybridization (FISH). Both methods are recommended by American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) 2013 guidelines. The primary aim of this analysis is to evaluate the economical and organizational impact by adopting FISH or SISH test for HER2 testing. We conducted an analysis to evaluate costs, times (laboratory personnel working hours) and laboratory-space to process a sample using the manual method (FISH) compared to the automated system (SISH). The analysis was performed from the pathology laboratory’s perspective. We analysed the complete workflow (laboratory personnel and medical resource used) to perform the two tests (FISH and SISH) during pathology laboratory standard working days. The time required to test one sample was timed for each methodology separately and the pertaining costs were calculated. The working dimension of the two technologies and of the instruments needed was also measured. The hands-on time for SISH was 76.25% lower than the implementation of FISH and the dedicated spaces needed to carry out the SISH test was 45.27% less than FISH. Lastly, the costs of using an automated SISH system were lower than FISH. As a consequence of a significant reduction of laboratory personnel working hours, medical resources used and pathology laboratory spaces, the use of SISH technique to identify HER2 status is a cost-saving alternative to FISH from the perspective of the pathology laboratory.