June 19, 2017 | Once again Diagnostics World will be attending the Next Generation Diagnostics Summit. The summit, taking place in Washington, D. C., August 15-18, will cover diagnostics challenges, solutions, and advances. We are looking forward to covering the Summit and its 12 different conference programs. Here are just a few of the talks we have highlighted so far for #NGDx17.
Harry Glorikian, author of Commercializing Novel IVDs: A Comprehensive Manual for Success, will speak about how the most successful molecular diagnostics companies in the upcoming years are going to be the ones that have the science right, but have been able to break down silos and get the commercialization part right, too. August 16 @ 5:10
Consumers want to take charge of their health, and the market for laboratory self-testing is growing. Although consumers can direct-access laboratory testing in some states, many buy their tests at the grocery, pharmacy, or over the internet. But, how do customers know the quality of the test kits they are purchasing? James H. Nichols, Medical Director of Vanderbilt University School of Medicine will cover the risks and errors that can occur with consumer diagnostics and ways that patients can ensure quality. August 15 @ 8:40
Minimally invasive diagnostic procedures, such as needle core biopsies or fine needle aspiration (FNA) often provide adequate material for molecular analyses. One of the greatest advantages of cytology samples in molecular testing is that they are often collected in non–formalin-based fixatives, and provide superior quality of nucleic acids that is more amenable to accurate interpretation of genomic sequence data. Such interventional biopsies can be subject to the challenges of neoplastic cellularity and tumor heterogeneity. Advances in precision oncology are trending toward the interrogation of limiting amounts of genomic material to guide clinical and therapeutic decisions. Helen Fernandes of the Columbia University Medical Center will address the current challenges in using small and degraded samples for genomic testing. August 15 @ 8:40
The emergence of drug resistance is an important factor in the management of clinically significant viral infections, particularly HIV-1. Genotypic drug resistance testing by conventional Sanger sequencing has limited sensitivity for low-frequency drug resistance mutations, whereas NGS methodologies allow the detection of minority variants associated with virological failure. Benjamin Pinsky from the Stanford University School of Medicine will focus on the clinical application of NGS to genotypic antiviral resistance testing. August 16 @ 9:30
Hsian-Rong Tseng from the University of California Los Angeles will briefly introduce the development of three generations of NanoVelcro CTC Assays, and highlight the clinical applications of each generation for various types of solid cancers, including prostate cancer, pancreatic cancer, lung cancer, kidney cancer, liver cancer, and melanoma. August 15 @ 8:40
Today, immuno-oncology is one of the most competitive fields in pharmaceutical research, and with its power to characterize the status of the immune system, flow cytometry is a key technology in evaluating the immune status of a patient, and changes in response to treatment. Flow cytometry is traditionally a method between science and art, suited for discovery work, useful in pre-clinical work, and difficult in clinical studies. With fast new developments in the technologies used in flow cytometry, the road is open to shape flow cytometry to overcome the typical challenges in the clinic (most notably, sample stability and assay reproducibility). Anka G. Ehrhardt, Director, Clinical Cytometry, Translational Medicine at Bristol-Myers Squibb, will outline a strategy using the power of simple tools (such as selecting the right blood collection tube, standardization, and normalization) and disruptive new technologies for point-of-care walk-away sample analysis in bringing flow cytometry assays up to the level of robustness required under real-life conditions. August 15 @ 11
Kinases provide attractive new therapeutic targets in acute leukemia, but the challenge is to identify patients who will benefit from a particular targeted therapy. Furthermore, sub-clonal genetic diversity can drive treatment resistance and relapse, highlighting the need for single cell biomarkers. Cynthia Guidos, Senior Scientist, Program in Developmental & Stem Cell Biology, Hospital for Sick Children Research Institute, Peter Gilgan Centre for Research and Learning will discuss our use of phospho-flow and mass cytometry to identify biomarkers of aberrantly active, therapeutically targetable signaling pathways in clinical leukemia specimens with single cell resolution. August 15 @ 12
Jerry Conway from Foundation Medicine will discuss how the reimbursement of comprehensive genomic profiling in cancer has been a large challenge. This new diagnostic approach framed as precision medicine is a confounder for payers who have traditionally covered molecular testing in cancer on a gene and tumor type basis. Cancer is a disease of the genome, and a comprehensive genomic profiling strategy proposes to sequence many cancer genes at once regardless of tumor type in order to uncover the bio-mechanistic rationale for the use or avoidance of high impact targeted and immunotherapy treatments. Some payers have started to cover and pay for this new transformative approach, and this session will reveal unique insights on why and how reimbursement is getting traction. August 15 @ 11
Cecilia Schott will discuss Capability Building and how it is a scalable approach that enables organizations to rapidly identify, build, and sustain the targeted capabilities needed to continuously improve performance and deliver impact. Diagnostics is a pillar of precision medicine and its complex evolution requires different approaches to build strong capabilities to systematically identify gaps, that can be fulfilled and result in greatest impact on the drug development and patient’s healthcare. As part of this approach, AstraZeneca developed The Core Diagnostic Capabilities Learning program, which underpins and connects the best learning assets on diagnostics ensuring a flexible approach that can be adapted to meet all cross-functional diagnostic needs. August 15 @ 2:05
Healthcare consumers are increasingly visiting nontraditional settings for medical care. Retail clinics are exploring how Point-of-Care (POC) testing can deliver quality care to this population. CVS Health’s Alexander Sbordone will review the benefits and challenges of offering POC testing in a retail health environment. The discussion will cover the operational, financial and regulatory material that MinuteClinic considers when reviewing POC testing performed in our clinics. It will also contrast the differences we have discovered between testing in the clinic environment and in the retail pharmacy. August 16 @ 3:40
Rita Colwell will be presenting on how next-gen sequencing, combined with high-resolution metagenomic analysis, offers a new powerful method for diagnosis of infectious diseases. Johns Hopkins University Bloomberg School of Public Health applied this in several clinical studies, including a retrospective case control study comprising samples of known and unknown etiology, as well as samples from healthy individuals. The results are promising and demonstrate that microbiome analysis could potentially differentiate healthy, diseased, and asymptomatic carriers, including individuals in the early stages of infection and disease. August 16 @ 6:10
MedImmune’s David E. Tabor will discuss global bacterial surveillance studies that employed whole genome sequencing to understand the genetic diversity within specific bacterial species. This is analogous to investigating the diversity of bacterial species in microbiome studies, but drilling down a layer to investigate the genomic diversity within given species of bacteria. The use of next-generation sequencing to replace traditional methods will be highlighted. August 16 @ 3:10
Large-scale reference data sets of human genetic variation are critical for the medical and functional interpretation of DNA sequence changes. The ExAC dataset contains variants from over 120,000 individuals aggregated from a variety of large-scale sequencing projects. In this presentation, Massachusetts General Hospital Research Fellow Monkol Lek will provide a general overview of the production of the ExAC dataset, recent updates, and discuss examples of how the dataset has been used for the interpretation of rare variants and development of methods available to the community. August 17 @ 8:30
With the explosion of genomic information and novel gene discoveries, clinical laboratories are faced with critical challenges in data interpretation. Laboratories must develop strategies that can incorporate data in the interpretation of genetic variants and review that variant classification over time. In addition, for complex genetic tests such as exome sequencing in pediatric population, the clinical presentation of patient continues to evolve, therefore affecting the phenotype-driven analysis of genomic data. Using clinical cases as examples, The Children’s Hospital of Philadelphia’s Avni B. Santani will address these challenges and propose strategies that clinical laboratories can utilize for re-analysis of genomic data in exome sequencing. August 17 @ 2:05
Recent studies, such as those of The Tumor Genome Atlas (TCGA), have demonstrated the complexity of non-small cell lung cancer (NSCLC) at the genomic level, both differentiating it from less complex cancers as well as indicating a remarkable degree of inter- and intra-patient tumor heterogeneity. Although overall response rates in oncogene-driven NSCLC exceed 60%, eventual emergence of acquired resistance and progressive disease is universal. Methodologies for identifying treatable abnormalities defined by predictive biomarkers at both the time of initial diagnosis and after the development of progressive disease have evolved rapidly over the last 5 years. David R. Gandara from the University of California, Davis Comprehensive Cancer Center will discuss this evolution and the increasing complexity associated with therapeutic decision-making, including the use of next-generation sequencing in tissue and plasma. August 16 @ 2:10
Fred R. Hirsch, CEO of International Association for the Study of Lung Cancer (IASLC), will speak about how immunotherapy is very encouraging in lung cancer and approved therapy both for first line treatment as well as for patients, who previously have progressed on chemotherapy for advanced NSCLC. August 17 @ 11
We are also considering several of the Summit’s Friday symposia including microfluidics and lab-on-a-chip devices for point-of-care testing; microbiome diagnostics; emerging cancer biomarkers; digital PCR; and more.