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Updated: Mar 17, 2026

Building Up a High-throughput Screening Platform to Assess the Heterogeneity of HER2 Gene Amplification in Breast Cancers
Published on: December 5, 2017
Novel method for rapid in-situ hybridization of HER2 using non-contact alternating-current electric-field mixing
Yoshitaro Saito1, Kazuhiro Imai1, Ryuta Nakamura2
1Department of Thoracic Surgery, Akita University Graduate School of Medicine, 1-1-1 Hondo, Akita, Akita 010-8543, Japan.
Abstract:
Human epidermal growth factor receptor 2 (HER2)-targeted agents are an effective approach to treating HER2-positive breast cancer patients. However, the lack of survival benefit in HER2-negative patients as well as the toxic effects and high cost of the drugs highlight the need for accurate and prompt assessment of HER2 status. Our aim was to evaluate the clinical utility of a novel rapid dual in-situ hybridization (RISH) method developed to facilitate hybridization. The method takes advantage of the non-contact mixing effect of an alternating current (AC) electric field. One hundred sixty-three specimens were used from patients diagnosed with primary breast cancers identified immunohistochemically as HER2 0/1(+), (2+) or (3+). The specimens were all tested using conventional dual in-situ hybridization (DISH), DISH with an automated slide stainer, and RISH. With RISH the HER2 test was completed within 6 h, as compared to 20-22 h needed for the standard protocol. Although RISH produced results more promptly using smaller amounts of labeled antibody, the staining and accuracy of HER2 status evaluation with RISH was equal to or greater than with DISH. These results suggest RISH could be used as a clinical tool to promptly determine HER2 status.
Insights
A new rapid dual in-situ hybridization (RISH) method significantly speeds up Human Epidermal growth factor Receptor 2 (HER2) testing for breast cancer. This faster RISH method provides accurate HER2 status evaluation, crucial for effective treatment decisions.
Area of Science:
- Oncology
- Molecular Pathology
- Biotechnology
Background:
- Human Epidermal growth factor Receptor 2 (HER2)-targeted therapies are vital for HER2-positive breast cancer.
- Accurate and prompt HER2 status assessment is critical due to limited benefits in HER2-negative cases and drug toxicities/costs.
- Current diagnostic methods for HER2 status can be time-consuming.
Purpose of the Study:
- To evaluate the clinical utility of a novel rapid dual in-situ hybridization (RISH) method for HER2 status assessment.
- To determine if RISH can provide accurate and timely results compared to conventional methods.
- To assess the feasibility of RISH as a clinical diagnostic tool.
Main Methods:
- Development of a novel RISH method utilizing an alternating current (AC) electric field for enhanced hybridization.
- Testing of 163 primary breast cancer specimens previously characterized by immunohistochemistry (HER2 0/1(+), (2+), or (3+)).
- Comparison of RISH results with conventional dual in-situ hybridization (DISH) and automated DISH.
Main Results:
- The RISH method completed HER2 testing within 6 hours, a significant reduction from the 20-22 hours required for standard protocols.
- RISH used smaller quantities of labeled antibody.
- HER2 status evaluation accuracy and staining quality with RISH were comparable or superior to conventional DISH.
Conclusions:
- RISH offers a rapid and accurate alternative for HER2 status determination in breast cancer.
- The method's speed and comparable/superior accuracy suggest its potential as a valuable clinical tool.
- Prompt HER2 assessment via RISH can facilitate timely treatment decisions for breast cancer patients.
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