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Next Generation Dx Summit Goes Virtual Offering Even More Content, Opportunities

August 6, 2020 | The Next Generation Dx Summit is going virtual later this month, offering a rich content experience with even more opportunity to learn through on demand sessions, live panel discussions, and plenty of digital networking events including a robust exhibit hall.  

Preparing for a virtual event through the Next Generation Dx Virtual platform is a bit different from our in-person conferences. Now we’re not limited by which room we’re in; we can flag talks across content areas getting even more learning out of the experience.  

Here are some of the sessions we’ve added to “My Agenda” so far. All times listed here are Eastern, but one you log in to the platform times should be local. –the Editors.  

Wednesday’s plenary session on ultrasensitive SARS-CoV-2 protein assays for precision clinical decisions will be delivered by David Walt, Harvard Medical School and Brigham and Women’s Hospital. Walt will report assays that can detect both active virus and prior infection and have been tested in thousands of individuals, including patients and healthcare workers. August 26, 11:15  

Following Walt’s presentation, a panel will outline lessons learned for diagnostic testing during the COVID-19 pandemic including how to address supply chain challenges, how to navigate and validate multiple platforms, issues of reimbursement, how to develop sustainable testing protocols, and the value of the tests currently available: PCR vs. antigen vs serology. Susan Hsiao, Columbia University Medical Center, moderates. Walt; Alex Greninger, University of Washington; and Jordan S. Laser, Northwell will discuss. August 26, 11:40 

Joe Wiencek, University of Virginia School of Medicine, says that the excitement of point-of-care testing technologies is often lost because of an assortment of practical obstacles. He will outline the challenges and practical solutions in implementing point-of-care testing. August 25, 9:25 

James Nichols, Vanderbilt University School of Medicine, will look at risk management for point-of-care testing, pinpointing errors that can come from a number of sources, including the instrument, the operator, the reagent, and the environment. Nichols will discuss the common sources of POCT error, describe how manufacturers are engineering their products to prevent errors, and will identify ways that institutions can design their quality control programs to minimize error. August 25, 10:10 

Individualized Quality Control Plans (IQCP) provides laboratories with flexibility in customizing quality control (QC) policies and procedures for non-waived testing, based on the test systems in use and the unique aspects of each laboratory. Jelani Sanaa, US Department of Health & Human Services, will explain how laboratories can achieve compliance by following manufacturer’s guidelines and all CLIA QC regulations as written. If those guidelines are less stringent than CLIA, or if the manufacturer does not provide guidelines, the laboratory must implement an IQCP. August 25, 10:50 

Šeila Selimović, Program Manager of the Early Notification to Act, Control, and Treat (ENACT), Division of Research, Innovation, and Ventures (DRIVe), Biomedical Advanced Research and Development Authority (BARDA), US Department of Health & Human Services, will explain how the ENACT Program within BARDA/DRIVe aims to protect Americans and save lives via pre-symptomatic technology. ENACT seeks pathogen and insult agnostic technologies to identify, characterize, and adapt signatures (biological, biometric, behavioral, and physiological) that can inform on health security threats or exposures prior to symptom onset to facilitate treatment and prevent subsequent cascading effects where possible. The program is exploring discovery and validation of biomarkers suitable for non-invasive or minimally invasive collection and other health signatures and tools, Selimović says, empowering individuals to take initial steps to determine health changes that assist clinician care by determining appropriateness of antibiotic vs. antiviral treatment and CBCs from remote settings, including the home. August 25, 12:45 

Jeanne Mumford, Johns Hopkins University, will look at point-of-care testing from the care coordinator’s perspective. While the ability to give access to testing to patient populations that may be underserved or underinsured is important and valuable, there are still concerns about quality assurance from the medical technologists who oversee point of care testing. August 25, 2:30 

Nations are not prepared for the adverse personal, societal, economic, and cultural impact of outbreaks, antimicrobial resistance, and disasters, says Gerald Kost, University of California, Davis. But Kost argues that point-of-care strategies can mitigate risk, reduce harm, and improve crisis standards of care. Global solutions integrate national POCT policy and guidelines and distribute financial burden and reasonable business models. August 26, 9:05  

Detecting early-stage recurrence of non-small cell lung cancer would allow clinicians to adapt or change therapy within a curative window, argues Lydia Sohn, Berkeley, greatly improving outcomes and mortality rates. Sohn will report on her group’s sensitive, simple-to-use, platform based on exogenous labeling that could detect tumor-derived extracellular vesicles in blood and saliva for patient monitoring. August 25, 10:50  

There is significant interest in determining to what extent non-invasive liquid biopsies reflect the gold standard solid biopsy. Peter Kuhn, University of Southern California, shares his approach for measuring patient-specific circulating and solid cell concordance by introducing tumor touch preparations to the high-definition single-cell analysis workflow for high-resolution cytomorphometric characterization. Patient-specific levels of concordance can readily be measured to establish the utility of circulating cells as biomarkers and define biosignatures for liquid biopsy assays. August 26, 10:10  

Diagnostic tools developed using machine learning must be evaluated using a 3-step process of deriving, validating, and establishing the clinical effectiveness of the tool. But how to assess if that process was done well? Yun Liu, Google Health, will explore how to read articles in the medical literature that use machine learning. Several key considerations are appropriate machine learning methods used for the type and size of data, proper tuning of pre-specified settings (called hyperparameters) on a dataset independent of the final validation set, and a rigorous reference standard. August 26, 1:50 

Breast cancer screening by mammography, which began in the U.S. about 40 years ago, has led to significant increases in the incidence of early-stage breast cancers, including ductal carcinoma in situ (DCIS), also called precancer or stage 0 disease. However, the expected reciprocal decrease in subsequent late-stage breast cancers was not found. It is now clear that some screen-detected breast “cancers” are indolent lesions without significant malignant potential. Alexander Borowsky, University of California, Davis, will explore the problem of breast cancer overdiagnosis and the precancer problem. August 27, 11:00 

Bruce Quinn, Bruce Quinn Associates, will explain how CMS drafts and finalizes national decisions (NCDs), and successful and unsuccessful approaches to public comment. For the MolDx program, he will analyze recent local decisions (LCDs), assess how to make effective comments, explain how LCDs are revised, and what timelines to expect. He will also outline how long it takes MolDx LCDs to be adopted across the 29 states in the MolDx program, and how the Master Edit File works. August 25, 11:10 

Access and reimbursement are key factors in a successful diagnostic product go-to-market strategy. For a companion diagnostic, the complexity increases based on pharmaceutical partner(s)’ drug access timeline, regulatory considerations, and fast changing or opaque in-country diagnostic access framework. Maude Champagne, Illumina, will paint a roadmap for companion diagnostic access. August 26, 9:50  

As a national medical practice, the goal at Genome Medical is to facilitate genomic testing and downstream care for those whose clinical findings, family history, or interest in finding out their risk of actionable genetic disease indicates a need for genetic care. Huntington Willard will explain how Genome Medical establishes key partnerships with testing laboratories, employers, health systems, and treatment centers that optimize access across a range of value-based products in both primary care and specialty care pathways. August 26, 1:50 

When launching new diagnostic tests, many factors converge including product performance, regulatory approval, insurance coverage and reimbursement. LabCorp, BioMérieux, Foundation Medicine, and Guardant Health all share some of their own approaches to new product launch.  

  • Jim Almas, LabCorp, says the current paradigm for coverage and reimbursement—seeking a code and seeking reimbursement from government payers, and then transitioning to the commercial and managed care settings—is unsustainable and won’t achieve value-based reimbursement for advanced diagnostics. He will explore other options for seeking more reasonable reimbursement for advanced diagnostics, particularly for COVID-19 diagnostics. August 25, 2:30 

  • Charudutt Shah, BioMérieux, says performance requirements, clinical validations, and regulatory approvals are only step one. He’ll cover several factors that drive successful commercialization and market access efforts required to make your product launch a success. August 27, 10:40 

  • Tesh Khullar has spent two decades in oncology. He will outline Foundation Medicine’s patient-centered commercialization strategy and will focus specifically on his team’s efforts to expand access to precision medicine for cancer patients through the company’s portfolio of comprehensive genomic profiling assays. August 27, 10:50 

  • And Daniel Simon, Guardant Health, will share Guardant’s current planning and strategy enter the companion diagnostic test market. August 27, 11:00 

Tiffani Lash, National Institutes of Health, will discuss the federal resources for early-stage companies that fall into the research portfolios of biosensors, platform technologies, and mHealth programs at NIH. She will explain the NIBIB Point-of-Care Technologies Research Network, which consists of three centers charged with developing point-of-care diagnostic technologies through collaborative efforts that merge scientific and technological capabilities with clinical need. August 27, 12:30 

The Department of Defense, Chemical and Biological Technologies Department is managing a disruptive portfolio developing algorithms to deliver warning of an acute exposure to a pathogen or toxic chemical prior to overt signs and symptoms using non-invasive biomarkers. Edward Argenta, Defense Threat Reduction Agency, will describe successes in both animal and human exposure studies and how the program plans to pursue advancing the research to provide early identification of exposure. August 26, 1:50 

Healthcare is transitioning from a fee-for-service model to one focused on value-based care. As a key component of patient care and the value-based equation, clinical laboratories will need to be an active participant in the development of diagnostic stewardship programs, so that healthcare providers are guided towards the “right test, for the right patient, at the right time.” Matthew Binnicker, Mayo Clinic and Chair, ASM’s Professional Development Subcommittee, will outline how to establish an effective diagnostic stewardship program, and provide examples of how healthcare providers can be guided towards appropriate testing and result interpretation. He will review specific cases and demonstrate how diagnostic stewardship can lead to increased efficiency, reduced cost, and improved patient care. August 26, 3:35 

Even though the global threat of antibiotic-resistant microorganisms is significant, many patients demand antibiotics and doctors are far too willing to provide them. Norman Moore, Abbott, will reveal how the relationship between us and our bacteria is more important than previously thought. Disrupting that balance can cause a host of medical issues. August 27, 11:00 

Hakan Sakul, Pfizer, moderates a panel asking why we still haven’t cracked the companion diagnostics nut and whether healthcare providers outside of oncology are actually ready to implement personalized medicine. Panelists include Wendy Rubinstein, FDA and Mark Curran, Janssen R&DAugust 25, 2:50 

Asaf Rotem, Dana Farber Cancer Institute, and others have been developed tools to uncover the transcriptomes of patient-derived single cells. Rotem will explain how this cutting-edge approach, complimented with other technologies, will help understanding tumors by creating detailed atlases. August 26, 1:50 

GeneChip Resequencing microarrays have been advanced for infectious disease agent detection and identification from Ebola to Zika. Next-generation sequencing with the highly mobile and cost-effective nanopore sequencing device is challenging the supremacy of the microarray in rapid point-of-need pathogen detection. Robert Duncan, Center for Biologics Evaluation and Research (CBER), FDA, will present results of side-by-side application of these two platforms for detection in pathogen-spiked blood samples and compare their performance. August 27, 9:05 

The progress of immunotherapy has been remarkable for patients with lung cancer, but Fred Hirsch, Icahn School of Medicine, Mount Sinai, argues that it is time to look into the role of “combined” biomarkers or assays for the most optimal selection of patients who benefit from immunotherapy. The current role of PD-L1 and TMB as predictive biomarkers will be discussed as well as potential new biomarkers for immunotherapy, such as genomic classifiers and the role of the microbiome for immunotherapy of lung cancer. August 26, 3:15 

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