Predictive assays: Analytic validation, clinical validation and clinical utility
Predictive assays are a key element of personalized healthcare because these assays aid physicians in selecting individuals who are most likely or least likely to benefit from specific therapies. In addition to analytical validation, predictive assays require clinical validation to establish their clinical utility. Krista Acosta, Manager, CDx Pharma Services Assay Development, Nicole Schechter, PSM, PMP, CDx Director, Project Leader and Alton Yates PhD, Senior Manager, Clinical Sciences Management, will address the development and performance differences between predictive assays developed under in vitro diagnostic regulations and laboratory developed tests.
RecordedAug 25 201655 mins
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Dr. Sonja Klebe of SA Pathology and Flinders University, Australia, will share data from two recently published studies investigating immunohistochemistry using various TTF-1 clones for diagnosis of lung cancer and metastases of other origins. She will discuss the sensitivity and specificity of the different TTF-1 clones and the resulting implications in identifying lung, prostate, and colorectal adenocarcinomas.
The Lopez-Rios lab and their colleagues throughout Spain have published a very informative study (The ROSING Study) on ROS1 in Journal of Thoracic Oncology. Dr. Fernando Lopez-Rios will be presenting the data from the manuscript and be available for questions following his live presentation.
In this webinar, Dr. Konnick will discuss the biology, background and
rationale for targeting TRK fusions. You will learn about the clinical
evidence for TRK inhibitors and issues implementing pan-tumor assays,
specifically pan-TRK assays.
Panel Discussion-Prioritizing Testing in the Context of Predictive Markers hosted by Dr. Paul A. Bunn Jr, MD. Panel participants include Dr. Philippe Taniere, MD, PhD, Dr. Erik Thunnissen, FBJM, and Dr Emd (Ed) Schuuring, Prof Dr.
Panel Discussion-Making Appropriate Diagnosis in Lung Cancer with Dr. Paul A. Bunn Jr, MD,as your host. The panel includes Dr. Corrado D'Arrigo, MBChB, PhD, FRCPath, Dr. Mark Kockx, MD, PhD, and Dr. Erik Thunnissen, FBJM.
Panel Discussion-Collaboration and Partnership between Oncologists and Pathologists with Dr. Paul A. Bunn, MD, as your host. Panel participants include Prof Dr. EMD (Ed) Schuuring, Prof Dr. HJM (Harry) Groen, and Dr. Corrado D'Arrigo, MBChB, PhD, FRCPath
The Dangers of Using a Laboratory-Developed Test as a Companion Diagnostic presented by Keith Miller, FIBMS, Director, UK National External Quality Assessment Scheme for Immunohistochemistry and in Situ Hybridization
Prof Dr EMD (Ed) Schuuring and Prof Dr HJM (Harry) Groen
ALK IHC vs ISH and ALK Inhibitors in Treatment of ALK-Positive Advanced NSCLC presented by Prof Dr. EMD (Ed) Schuuring, Clinical Scientist in Molecular Pathology, University Medical Center Groningen The Netherlands and Prof Dr. HJM (Harry) Groen, Pulmonologist, University Medical Center Groningen The Netherlands.
Prof Dr EMD (Ed) Schuuring & Prof Dr HJM (Harry) Groen
Join Dr. Ed Schuuring and Dr. Harry Groen, University Medical Center Groningen, The Netherlands, to explore the role of immunohistochemistry (IHC) in the assessment of ALK rearrangements in non-small cell lung cancer (NSCLC), with a focus on the binary algorithm and comparison with fluorescence in situ hybridization (FISH). Clinical implications for ALK IHC vs. FISH and treatment options for ALK inhibitors will be discussed including side effects and overall as well as intracranial efficacy.
In this webinar, Dr. Flores will summarize the PD-L1 testing assays currently available on market and address the importance of understanding the different scoring algorithms developed for their respective PD-1/PD-L1 immunotherapies. You will learn about a system approach to testing and where to find further information on how to appropriately interpret the specific PD-L1 assay you are working with.
There is an ever increasing need to understand the role of the Tumor Microenvironment (TME) in Cancer Immunotherapy. In this webinar, Drs. Lei Tang, PhD and Mehrnoush Khojasteh,PhD of Roche Tissue Diagnostics (Ventana Medical Systems, Inc.), present their work on multiplex immunofluorescence staining and digital pathology analysis in a CAP/CLIA certified laboratory. Multiplexed immunohistochemistry (IHC) enables the spatial characterization of TME immune cells and tumor cells by detecting multiple biomarkers while preserving tissue morphology. Co-expression of multiple biomarkers and relative spatial relationships requires whole slide digital pathology image analysis algorithms that are tailored to individual assays and their intended uses. The process described in this presentation demonstrates how multiplexing and digital pathology enable biotech and pharmaceutical research and development teams to explore the potential medical value of specific biomarkers,
Professor Keith Kerr, MB, ChB, FRCPath, FRCPE, Consultant Pathologist, Department of Pathology, University of Aberdeen, Aberd
Immunotherapy is changing the cancer care paradigm: for a small but significant group of patients, cancer has become a chronic disease and immunotherapy biomarkers like PD-L1 play an important role. In this presentation, Professor Kerr will provide a summary of the immunotherapy treatment landscape, address what makes immunotherapy biomarkers unique compared to biomarkers like HER-2 and ALK, describe the function (physiologic and as a biomarker) of PD-L1 and other biomarkers relevant to the PD-1/PD-L1 pathway. He will also address the role of emerging immunotherapy biomarkers that are independent of the PD-1/PD-L1 pathway.
Zin Htway, PhD, MBAHM, CT (ASCP, IAC), Maria Magana, Danielle Westfall, MD, Los Robles Hospital and Medical Center
Surgical procurement of adequate tissue can be challenging. This presentation will be an in-depth look at rapid on-site evaluation of tissue biopsies from various sites. Best practices for handling, grossing and histology sectioning of tissue biopsies for companion diagnostics will be discussed. This will be followed by a brief overview of this approach applied to immunohistochemistry stains and fluorescence in situ hybridization.
CDx Insights is a series brought to you by Roche. We are committed to providing you with educational content, from key opinion leaders, related to personalized diagnostics. We aim to ensure on ongoing conversation is taking place in this evolving area of healthcare.
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