Breast cancer is the most common cancer diagnosed in women and the second leading cause of female cancer death in the United States. In the last 25 years, the number of therapeutic options for breast cancer has increased, improving survival for breast cancer patients. Selecting appropriate targeted therapy for breast cancer patients starts with pathology. The pathologic diagnosis and testing for breast biomarkers, estrogen receptor, progesterone receptor, and HER2, are essential for determining the need for additional tumor testing and for selecting appropriate therapy that will give each breast cancer patient the best chance at improved survival. 

Learning Objectives:

• Classify breast cancer based on biomarker status. 
• Associate targeted therapies for breast cancer with the pathways driving tumor growth that these drugs block. 
• Identify key items in the pathology report that are important for selecting appropriate therapy and ordering additional tests for breast cancer. 
• Review challenges that pathology faces, past and present, in breast cancer testing. 

The practice of pathology is rapidly undergoing a transformation in which multiple tools such as digital imaging, advanced artificial intelligence algorithms, and computer-aided diagnostic techniques are being linked with molecular pathology resulting in increased diagnostic power based on the ability of modern-day pathologists to use these new tools and to interpret the data generated by them. 

Automated whole slide imaging (WSI) scanners are now rendering diagnostic quality, high-resolution images of entire glass slides and combining these images with innovative AI-based decision support tools that are making it possible to integrate imaging into all aspects of pathology reporting including anatomical, clinical and molecular pathology. The recent approvals of WSI scanner for primary diagnosis by FDA as well as the approval of prostate Al algorithm has paved the way for starting to incorporate this exciting technology for use in primary diagnosis Once the slides are digitized, artificial intelligence and computational pathology tools will serve as a platform for innovations and advances in anatomical and clinical pathology in the future. This talk will describe where we are in the journey towards utilizing these tools for clinical diagnostics and what are the possibilities, once fully implemented.

Learning Objectives:

• Outline an overview of the evolution of digital pathology and AI and its current state for clinical diagnostics, research and education
• Identify the challenges and opportunities for implementing digital pathology and AI in the clinical areas using OSU as an example
• Assess the future directions of Digital Pathology /Artificial Intelligence technology’s role in advanced diagnostics

Worldwide gastric cancer is the 5th most common cancer and the 4th leading cause of cancer deaths. Its highest incidence rates are in east Asia and eastern Europe with low incidence rates in North America and Northern Europe. Overall, gastric cancer has a poor prognosis and often demonstrates regional spread to lymph nodes (in about a quarter of the patients) and distant spread (metastatic disease), in about a third of the patients at the time of diagnosis.

Over the past several years, there have been increasing requests for biomarker testing in gastric and gastroesophageal junction (GEJ) adenocarcinomas. The standard first line treatment for patients with locally advanced inoperable or metastatic gastric adenocarcinoma has been chemotherapy, with a median overall survival of 1 year. Combining targeted therapies with chemotherapy can improve survival. In patients with Her2 positive gastric and GEJ adenocarcinoma, trastuzumab has been approved in combination with chemotherapy. In these patients, assessment of HER2 overexpression in the tumor using immunohistochemistry or in-situ hybridization is recommended by the National Comprehensive Cancer Network (NCCN). All patients with newly diagnosed gastric cancer should also undergo biomarker testing for identification of MSI-H/dMMR gastric adenocarcinoma in consideration for administration of immunotherapy. Checkpoint inhibitor therapy is utilized in combination with chemotherapy as first line therapy in some countries, however, efficacy is mainly in patients with a PD-L1 CPS score of 5 or more. For patients who have HER2 negative disease, and who have a PD-L1 CPS less than 5, an emerging therapeutic target is high Claudin-18 isoform 2 (CLDN18.2) expression.

Learning Objectives:

• Describe current recommendations for biomarker testing in gastric and GEJ adenocarcinomas.
• Review guidelines for testing and interpretation of HER2 by immunohistochemistry and in-situ hybridization.
• Review the current recommended guidelines MSI-H/dMMR testing and PD-L1 with challenges in interpretation of scoring
• Describe the utility of CLDN18.2 as a biomarker in the management of gastric and GEJ adenocarcinoma.  

Lung cancer is still responsible for most cancer-related deaths for both genders in the United States. Traditionally, diagnosis and management of patients has been based on tissue biopsy to identify the major lung cancer categories. Although early stages of lung cancer are mainly managed surgically, it has become more evident in the past 10-15 years that the management of metastatic and advanced cases of lung cancer are based on a combination of pathologic findings, molecular profiling and clinical staging. The traditional molecular testing for EGFR, ALK and ROS1 has been expanded in view of newly developed targeted therapies, and the availability of Next Generation Sequencies and liquid biopsies. Immunotherapies targeting the PD-1/PD-L1 are also part of current treatment arsenal available for lung cancer. This presentation will review the recommended molecular testing for lung cancer, biopsy and tissue guidelines as well as current methologies.

Learning Objectives:

• Describe the current recommendations for molecular testing for non-small cell carcinoma
• Review the guidelines for tissue biopsy handling for lung cancer diagnosis and molecular testing
• Review current guidelines for testing and interpretation of companion and complementary PD-L1 by immunohistochemistry
• Summarize recent outcomes of lung cancer patients treated with a precision medicine approach

The field of Precision Medicine is rapidly advancing, revolutionizing cancer diagnostics with molecular biomarkers that enable diagnostic classification, prognostic risk stratification, and therapeutic risk prediction. However, this progress is accompanied by several challenges that demand innovative solutions. This plenary lecture aims to explore the hurdles encountered in Precision Medicine and propose strategies to overcome them.

Learning Objectives:

• Summarize the reasons for growth of Precision Medicine-based testing

• Review challenges that are impacting the growth of Precision Medicine

• Identify opportunities to enhance clinically appropriate testing to enhance the practice of Precision Medicine