Clinical Study

Optimizing Her2 Testing In Oncologic Pathology: A Comparative Analysis Of Ihc, Ish, And Ngs

Posted Date: Mar 19, 2025

  • Investigator: Rachel Jug
  • Specialties: Gynecologic Oncology, Pathology
  • Type of Study: Observational/Survey

HER2/Neu is a growth factor receptor protein encoded by the proto-oncogene ERBB2. It is a well-known prognostic and therapeutic biomarker in breast cancer diagnosis and treatment. Studies have shown high concordance rate above 90% between HER2 IHC and CISH test in breast cancers. 2018 ASCO/CAP streamlined laboratory testing of HER2 status in breast cancer with the consensus that CISH will be performed only in IHC 2+ cases where there is lower concordance rate between IHC and CISH. In recent years, HER2 testing has gained popularity in gynecological cancers such as endometrial serous carcinoma and gastrointestinal cancers such as gastro-esophageal adenocarcinoma. Targetable therapy such as trastuzumab has been added to standard chemotherapy for HER2-overexpression entities. With the growing interest to understand HER2 status in other cancer patients, HER2 testing algorithm has not been characterized in non-breast carcinomas. Within breast carcinomas, there is still a gap in testing algorithms now that NGS is increasingly being performed potentially resulting in redundant costly testing. Our study will evaluate NGS test performance of ERBB2, MSS/MSI and P53 mutations by comparing with corresponding IHC and CISH or FISH to determine if NGS alone would be sufficient to detect these diagnostic biomarkers in various cancers, including endometrial cancer, breast cancer, and GI cancers. Our results will add to literature to support the development of consensus HER2, MSS/MSI and P53 testing protocols in various cancers.

Criteria:

Null

Keywords:

Her2, Ngs, Molecular

For More Information:

Rachel Jug
NULL
jugrl@ucmail.uc.edu