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Updated: Apr 18, 2026

Protocol for HER2 FISH Using a Non-cross-linking, Formalin-free Tissue Fixative to Combine Advantages of Cryo-preservation and Formalin Fixation
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Short formalin fixation and rapid microwave processing do not affect HER2 testing.

Isabella Sassi1, Francesca Invernizzi, Claudio Doglioni

  • 1Department of Pathology, San Raffaele Scientific Institute, Università Vita-Salute San Raffaele, Milan, Italy.

Recent Results in Cancer Research. Fortschritte Der Krebsforschung. Progres Dans Les Recherches Sur Le Cancer
|February 1, 2015
PubMed
Summary
This summary is machine-generated.

Shortening formalin fixation time to 30 minutes and using microwave technology for processing allows for accurate and reproducible HER2 testing in breast cancer. This rapid method ensures reliable results for guiding patient therapy and prognosis.

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Area of Science:

  • Oncology
  • Pathology
  • Biotechnology

Background:

  • Accurate immunohistochemical testing for estrogen and progesterone receptors, HER2, and Ki67 is crucial for breast cancer therapy selection and prognosis.
  • Preanalytic factors, such as fixation time and type, significantly impact the reliability of these diagnostic assays.
  • Current ASCO-CAP guidelines recommend a minimum of 6 hours fixation for HER2 testing, but scientific evidence supporting this specific duration is limited.

Purpose of the Study:

  • To investigate the feasibility of achieving adequate and reproducible HER2 assessment using a significantly reduced fixation time.
  • To evaluate the impact of rapid processing with microwave technology on HER2 testing accuracy.
  • To compare the reliability of HER2 evaluation with short fixation protocols against standard longer fixation times.

Main Methods:

  • Breast carcinoma biopsies were subjected to a short fixation protocol (30 minutes).
  • Rapid tissue processing was performed using microwave (MW) technology (69 minutes).
  • HER2 status was assessed and compared to results from corresponding surgical specimens processed with standard 24-hour formalin fixation.

Main Results:

  • A short fixation time (30 minutes) combined with rapid microwave processing achieved adequate and reproducible assessment of HER2 status.
  • HER2 evaluation results from the short-fixation protocol were comparable to those obtained from routine 24-hour formalin fixation.
  • The findings suggest that reduced fixation times are viable for reliable HER2 testing.

Conclusions:

  • Shortening formalin fixation time to 30 minutes is sufficient for reliable HER2 assessment in breast cancer.
  • Microwave technology enables rapid processing, maintaining the accuracy of HER2 immunohistochemistry.
  • These findings challenge the current 6-hour minimum fixation guideline and offer a faster diagnostic pathway.