HER2 over-expression/gene amplification is present in 15-20% of breast cancer and is recognized as an important prognostic and predictive biomarker associated with a more aggressive clinical course of disease. This observation led to the development of therapies that target the HER2 pathway which have demonstrated remarkable clinical efficacy in clinical trials and clinical practice. In this webinar, we will review the role of the pathology lab and the basis of HER2 testing, what steps can be taken to help insure accurate and reliable results and some of the ongoing challenges faced by pathologist and oncologist in determining a reliable and action HER2 status in patients with breast cancer.
Additionally, we will review the role of the core lab and how Serum HER-2/neu levels can be used to monitor metastatic breast cancer patients whose status determined by tissue testing is either HER/2/neu positive or HER-2/neu negative. Serum HER-2/neu levels can be used to aid in monitoring metastatic breast cancer patients treated with chemotherapy, hormonal therapy, radiotherapy, and HER-2/neu–targeted therapies.1-4
Learning objectives:
- Explain the role of the pathologist in the diagnosis and treatment planning for patient with a diagnosis of invasive breast cancer
- Explain how HER2 testing is performed on diagnostic breast cancer biopsies and what steps need to be taken to help ensure the accuracy, reproducibility, and reliability of testing results
- Explain what is new in HER2 testing and some of the challenges with providing accurate and reliable HER2 testing results
- Explain the role of the core lab in monitoring treatment for patient with HER2+ metastatic breast cancer
Speakers
Dr. David G. Hicks
Director, IHC/ISH Laboratory & Chief of the Breast Subspecialty Service - University of Rochester Medical Center
Dr. Hicks' innovative approaches to improving efficiency and quality in surgical pathology have been highlighted in publications and invited lectures sponsored by national pathology organizations. His organizational interests are in the development of a subspecialty-based surgical pathology system, combining disease-specific diagnostic and prognostic expertise with translational research based on organ systems and disease categories. Dr. Hick’s current research interests focuses on the molecular genetic profiling of clinical samples from patients with cancer. Dr. Hicks served as a member of the ASCO/CAP consensus panel for both the ER/PR and HER2 testing guidelines. He has presented numerous workshops and platform presentations for at the ASCP, USCAP and the CAP annual meetings over the years.
Steven A. Noel, PhD (DABCC), MT (ASCP)
Vice President of Lab Operations - Drugscan, Inc., Warminster, PA
Dr. Noel is a board-certified Clinical Chemist, receiving his doctorate from The Ohio State University. He has served in different capacities in laboratory medicine throughout his 40-year career. As a Clinical Chemist, Dr. Noel served as Technical Director in hospital and commercial laboratories. He is currently the as the VP of Operations at Drugscan. He has also worked for Siemens as a clinical consultant. Dr. Noel has published on clinical laboratory immunoassay topics across multiple disease states.
