Economic evaluation of the organizational impact of adopting different in situ hybridization technologies to assess HER2 gene amplification in breast cancer

Valutazione Economica Dell'impatto Organizzativo di Differenti Tecniche di Ibridazione in Situ per la Determinazione Dello Stato di HER2 nel Carcinoma Alla Mammella

Abstract

Objective Human epidermal growth factor receptor 2 (HER2) status identification is established by immunohi-stochemistry and in situ hybridization (ISH). Silver in situ hybridization (SISH) is an alternative technique to the fluorescence in situ hybridization (FISH). The American Society of Clinical Oncology (ASCO) and College of American Pathologists (CAP) 2013 guidelines recommend both methods. The primary aim of this analysis is to evaluate the economical and organizational impact of adopting FISH or SISH methods for HER2 testing. Methods We conducted an analysis to evaluate costs, staff times (laboratory 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 perspective. We analysed the complete workflow (laboratory per-sonnel 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. Results The hands-on time for SISH was 80% lower than for FISH and the dedicated space needed to carry out the SISH test was 45% less than FISH. Finally, the costs of laboratory personnel (operator + pathologist) using an automated SISH system were lower than FISH (-58%). Conclusions As highlighted by the significant reduction of laboratory staff 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.