Track 3: Cancer Tissue Diagnostics 

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Sunday, May 5

5:00-6:00 pm Conference Pre-Registration

Monday, May 6

7:30-8:30 am Conference Registration and Morning Coffee

8:30-8:40 Welcome Remarks from Conference Director

Julia Boguslavsky, Executive Director, Conferences, Cambridge Healthtech Institute

Whole-Slide Imaging and Digital Pathology 

8:40-8:45 Chairperson’s Opening Remarks

8:45-9:10 Validation of Whole Slide Imaging in Pathology

Liron Pantanowitz, M.D., Associate Professor, Pathology and Biomedical Informatics, University of Pittsburgh Medical Center

Validation of whole slide imaging (WSI) is important to ensure that digitized slides are at least equivalent to that of glass slides. The College of American Pathologists (CAP) Pathology and Laboratory Quality Center convened a panel to recommend validation requirements for WSI systems to be used for clinical diagnostic purposes employing a combination of evidence-based evaluation of the literature, expert consensus and public commentary. The recommendations are comprehensive and address technical, interpretation components and administrative issues related to WSI in pathology providing practical guidance for all types of laboratories who are using or plan to utilize WSI systems for diagnostic clinical work. This session will educate participants about WSI in pathology, the regulatory issues surrounding digital pathology, and review the validation guidelines developed by the CAP.

9:10-9:35 New Applications Utilizing Whole Slide Digital Imaging for Anatomic Pathology Inter- and Intra-Lab Peer Review and Benchmarking Quality Assurance

Mark Priebe, MT(ASCP)SBB, Managing Director, QualityStar Quality Consortium

Although application of Whole Slide Digital Imagining (WSI) for primary diagnosis is limited by the FDA at this time, WSI is a significant enabling technology for anatomic pathology (AP) quality assurance (QA) initiatives both inter- and intra-laboratory. This presentation will review current AP/QA programs and the application of WSI to a novel approach of gaining longitudinal benchmarking data for quality review. The presentation will focus on understanding design requirements for development and implementation, investment requirements, confidentiality considerations and methods to encourage pathologist participation and acceptance.

9:35-10:00 Label-Free Infrared Spectral Histopathology: Diagnostics and Prognostics

Max Diem, Ph.D., Professor, Chemistry and Chemical Biology, Northeastern University

Infrared spectral histopathology is a method in which the biochemical composition of a histopathological sample is used, rather than morphometric criteria, to diagnose disease. To this end, thousands of infrared spectra are collected from pixels about 10 µm on edge, and analyzed to produce spectral images that detect abnormality based on variations in composition. The accuracy of this method is comparable to multi-panel immunohistochemistry.

10:00-10:30 Networking Coffee Break

10:30-10:55 Tumor Heterogeneity Assessed by Immunohistochemistry of Multiplexed Protein Biomarkers

Steve Schmechel, M.D., Ph.D., Associate Professor, Pathology, University of Washington School of Medicine

Intratumoral heterogeneity of protein expression may be linked to the biological aggressiveness of tumors and selection of therapies. Analytical and statistical methods to quantify heterogeneity are needed, particularly for multiplexed assays. This presentation will discuss novel methods to measure tumor heterogeneity.

10:55-11:20 Application of WSI in Consensus Review for Clinical Trials

Stephen M. Hewitt, M.D., Ph.D., Clinical Investigator, Laboratory of Pathology, National Cancer Institute, NIH

Whole Slide Imaging is an enabling technology within pathology, altering all aspects of current practice. Consensus review processes for clinical trials have previously been expensive, slow, and complicated by issues of reproducibility. Whole Slide Imaging and distributed review overcome many of these issues, and provide new opportunities that have previously not been feasible.

11:50-1:20 pm Enjoy Lunch on Your Own

NGS in Clinical Use 

1:20-1:25 Chairperson’s Remarks

1:25-1:50 College of American Pathologists’ Standards and Proficiency Testing for Next-Generation Sequencing for the Clinical Laboratory

Nazneen Aziz, Ph.D., Director, Molecular Medicine, Transformation Program Office, College of American Pathologists

The rapid and ongoing advances in the genetic test market, spurred by the opportunities of Next-Generation Sequencing (NGS), necessitate many facets of the health care industry to work cohesively. Adoption of NGS as a clinical test requires the adoption of many processes and procedures, such as the analytic and clinical validation of the test, CLIA certification/CAP accreditation, standards for reference materials, availability for proficiency testing, genetic counseling, and questions regarding reimbursement, informed consent and incidental findings. This talk will focus on the laboratory requirements developed at CAP for CLIA/CAP accreditation and the plans for proficiency testing for NGS.

1:50-2:15 Assuring the Quality of Next-Generation Sequencing in Clinical Laboratory Practice

Ira M. Lubin, Ph.D., FACMG, Team Lead, Genetics, Division of Laboratory Science and Standards, Centers for Disease Control and Prevention

Integration of next-generation sequencing (NGS) into the clinical laboratory requires test validation, establishment of quality control procedures, and the independent assessment of test performance by proficiency testing or alternate approaches. Existing regulatory requirements and professional guidance do not adequately address these quality issues for clinical NGS testing. This talk will describe the outcomes of a national workgroup organized by the Centers for Disease Control and Prevention tasked to identify principles and develop guidance to promote good clinical laboratory practices for NGS and meet regulatory and professional standards.

2:15-2:40 Clinical NGS: Validation, Reporting and Economics

Seth Crosby, M.D., Director, Partnerships & Alliances, Washington University School of Medicine

As NGS enters the clinic, matters of analytic and clinical validation are just the start of the medical director’s worries. How should results be quickly generated and communicated to a physician in a meaningful and actionable manner? What are the new rules for billing and reimbursement?

2:40-3:40 Refreshment Break in the Exhibit Hall with Poster Viewing

3:40-4:05 Exome Sequencing in a Clinical Setting to Guide Patient Care

Madhuri Hegde, Ph.D., Executive Director, Emory Genetics Laboratory; Associate Professor, Human Genetics, Emory University School of Medicine

Advances in genomic medicine have made it necessary for clinical laboratories to rapidly implement new technologies to guide patient care. Exome sequencing is being rapidly being implemented across different specialties such as inherited diseases, cancer and infectious diseases. This talk will focus on the clinical utility of exome sequencing in patient care with real case examples.

4:05-4:30 Interpreting Clinical Next-Generation Sequencing Data: Current Challenges and Hope for the Future

Elaine Lyon, Ph.D., Medical Director, Molecular Genetics; Co-Medical Director, Pharmacogenomics, ARUP Laboratories; Associate Professor, University of Utah

With the complexity of genomic scale sequencing (next-generation sequencing or NGS) and the massive amounts of data obtained, informatics is essential. Two challenges in evaluating a variant are 1) is it real and 2) is it clinically significant. Informatics allow alignment and variant calling (differences from a reference sequence), and sifting of probable clinically insignificant variants. More challenging is prioritizing variants that are likely to be associated with the clinical symptoms. In addition to the symptom-guided analysis approach, NGS data can reveal variants in genes related to drug metabolism that may affect efficacy or response. This presentation will discuss approaches to prioritize symptom-related variants as well as the potential of NGS data for companion diagnostics or therapeutics.

4:30-5:00 Panel Discussion

Panelists to be Announced

5:00-6:00 Welcome Reception in the Exhibit Hall with Poster Viewing

6:00-9:00 Dinner Courses

Fit-for-Purpose Biomarker Assay Development and Validation
Next-Generation Sequencing as a Clinical Test

(Separate registration required)

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