The evaluation of erb-b2 receptor tyrosine kinase 2 (ERBB2 or HER2) gene amplification status through Dual in Situ Hybridization (DISH) currently relies on manual assessment by pathologists. There are several deep learning-based algorithms for H&E or ISH analysis. However, DISH analysis tools are still lacking.

We developed a fully automated deep learning-based quantification system to assist pathologists in identifying the most relevant cells throughout the entire DISH image. In the comparison between pathologists and the auto-quantification system, the overall percentage agreement (OPA) by case was 88. 9% (80/90).

These results demonstrate that each image, with a processing time of approximately 1 minute, achieves similar results compared to pathologists’ assessments, while the manual procedure will take 10-20 times longer to examine the same specimen.

This approach offers a versatile system for bright-field HER2 DISH image analysis. The system provides faster, cheaper, standardized, and versatile diagnostic tools to aid pathologists in the HER2 DISH diagnostic process.

The authors have declared no competing interest.

This study was funded by National Science and Technology Council

I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained.

Yes

The details of the IRB/oversight body that provided approval or exemption for the research described are given below:

Ethics IRB of Medical Ethics and Institutional Review Board of Taoyuan General Hospital, Ministry of Health and Welfare gave ethical approval for this work.

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Yes

I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance).

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I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable.

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All data produced in the present study are available upon reasonable request to the authors

Due to privacy protections for patient histopathology image data and patient clinical data, we are unable to make all data public.