08:00 | Conference Registration, Materials Pick-Up, Morning Coffee and Breakfast Pastries |
| Session Title: Emerging Technologies and Innovation in Point-of-Care (POC) Diagnostics |
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09:00 | | Keynote Presentation Printable Paper-Based Point-of-Care Aptasensors for Biomedical Monitoring John Brennan, Professor and Director, Biointerfaces Institute, McMaster University, Canada
The talk will focus on the development of printable components to produce easily manufactured bioactive paper sensors with a range of capabilities, including integrated sample preparation, aptamer-based biorecognition, isotrhermal DNA amplification and text-based readout technologies. Examples will be provided to demonstrate multi-step reactions on paper for ultra-sensitive detection of infectious organisms and cancer biomarkers. |
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09:30 | | Keynote Presentation Shortening Development Time and Improving Performance of Rapid Diagnostic Tests Bernhard Weigl, Director, Center for In-Vitro Diagnostics, Intellectual Ventures/Global Good-Bill Gates Venture Fund, United States of America
Lateral flow and similar rapid diagnostic assays (LFAs) are easy to use and manufacture, low cost, rapid, require little or no equipment to operate, and do not need to be refrigerated. However, they are generally not considered to be very sensitive or able to provide a quantitative result. This lack of sensitivity is not a fundamental property of LFAs but rather a consequence of the way they are developed, manufactured, and marketed. Historically, most lateral flow tests were developed and optimized by relatively small manufacturers with limited R&D capabilities and budgets, and were generally used only for analytical targets prevalent at high concentration in patient’s samples that were relatively easy to measure.In contrast, our group’s mission is to develop LFA-based assays for use in global health applications that are as sensitive as the best conventional diagnostic assays (in some cases even better) while retaining all their cost, simplicity, and usability advantages. We have developed a 3D modeling platform for paper-based assays and are using it to determine the theoretical limit of a particular assay variant, as well as a rapid array-based empirical optimization system for lateral flow assays. Together, these approaches allow the development of more sensitive assays with shortened development time. In this presentation we will describe the assay optimization methods we employ, as well as several assays under development, including ones for malaria, and TB. |
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10:00 | | Keynote Presentation Programmable Bio-Nano-Chip Platform: A Point-of-Care Biosensor System with the Capacity to Learn John T McDevitt, Professor, Division of Biomaterials, New York University College of Dentistry Bioengineering Institute, United States of America
The combination of point-of-care (POC) medical microdevices and machine learning has the potential transform the practice of medicine. In this area, scalable lab-on-a-chip (LOC) devices have many advantages over standard laboratory methods, including faster analysis, reduced cost, lower power consumption, and higher levels of integration and automation. Despite significant advances in LOC technologies over the years, several remaining obstacles are preventing clinical implementation and market penetration of these novel medical microdevices. Similarly, while machine learning has seen explosive growth in recent years and promises to shift the practice of medicine toward data-intensive and evidence-based decision making, its uptake has been hindered due to the lack of integration between clinical measurements and disease determinations. In this talk, recent developments in the programmable bio-nano-chip (p-BNC) system, a biosensor platform with the capacity for learning will be highlighted. The p-BNC is a ‘platform to digitize biology’ in which small quantities of patient sample generate immunofluorescent signal on agarose bead sensors that is optically extracted and converted to antigen concentrations. The platform comprises disposable microfluidic cartridges, a portable analyzer, automated data analysis software, and intuitive mobile health interfaces. The single-use cartridges are fully integrated, self-contained microfluidic devices containing aqueous buffers conveniently embedded for POC use. A novel fluid delivery method was developed to provide accurate and repeatable flow rates via actuation of the cartridge’s blister packs. A portable analyzer instrument was designed to integrate fluid delivery, optical detection, image analysis, and user interface, representing a universal system for acquiring, processing, and managing clinical data while overcoming many of the challenges facing the widespread clinical adoption of LOC technologies. We demonstrate here the p-BNC’s flexibility through the completion of multiplex assays within the single-use disposable cartridges for numerous clinical applications including prostate cancer, ovarian cancer, and acute myocardial infarction. Toward the goal of creating ‘sensors that learn’, we have developed and describe here the Cardiac ScoreCard, a clinical decision support system for a spectrum of cardiovascular disease. The Cardiac ScoreCard approach comprises a comprehensive biomarker panel and risk factor information in a predictive model capable of assessing early risk and late-stage disease progression for heart attack and heart failure patients. |
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10:30 | Coffee Break and Networking in the Exhibit Hall |
11:15 | Facilitating Point of Care Technology (POC) Development for Sexually Transmitted Infections (STI) Joany Jackman, Senior Scientist, Technical Lead, Technology Development Core, Johns Hopkins Center for Point-of-Care Technologies Research for Sexually Transmitted Diseases, The Johns Hopkins University Applied Physics Laboratory, United States of America
The Johns Hopkins University Center for Point of Care Technology (POCT) for Sexually Transmitted Diseases (STD) is one of three collaborating centers in the Point-of-Care Technology Research Network (POCTRN) hosted by the National Institute of Health (NIBIB). The purpose of our Center is to assist developers of POCT along the process of commercialization. Similar to other Centers in the POCTRN, the mission of the JHU Center for POCT for STD is to facilitate technology development by providing a number of tools and resources to enhance POCT performance. These resources include 1)access to subject matter experts, 2) technical design reviews, 3)information on best practices, market characteristics and end user needs, 4) provide patient samples at no cost, 5) evaluate devices in clinical settings and at low resource sites, 6) access to our Technology Watch Database and 7) targeted funding for key developmental concepts. 86% of the technologies funded through the Center have been successful in obtaining additional funding to sustain their advancement towards commercialization. |
11:45 | | Keynote Presentation Advances in Paper-Based and 3D Printed Microfluidics for Emerging Disease Detection Charles Henry, Professor and Chair, Colorado State University, United States of America
There is a continuing interest in the development of low-cost fabrication methods and materials to create microfluidic devices for applications ranging from point-of-care monitoring to in vitro studies of disease biology. Two newer methods for fabricating devices include paper-based microfluidics and 3D printed devices. This talk will discuss novel aspects of both types of microfluidic devices and their use for detecting pathogenic bacteria and viruses. Paper-based analytic devices have been used for centuries but a renewed interest in the substrate as a material for microfluidics started a decade ago when patterned paper was used to carry out multiplexed chemical analysis of urine samples. Recent results from our groups has focused on detecting bacteria, including anti-microbial resistant bacteria, as well as emerging viral pathogens. We have shown that chemistry can be developed with a range of selectivity from very specific (immunoassay and DNA-based) to general (enzyme-based). Use of the system to detect antimicrobial resistance in surface water will be presented as an effort towards understanding horizontal transfer of resistance within the environment. We have also developed an electrochemical paper device that can detect virus particles from complex sample matrices. While paper-based devices have utility for point of care measurements, there is also interest in the use of 3D printed microfluidic devices for this application. Development of a reusable 3D printed microfluidic system for virus and bacteria detection will be presented. |
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12:15 | Networking Lunch in the Exhibit Hall -- Meet the Exhibitors and View Posters |
| Session Title: Applications of POC Diagnostics in Rapid Testing and Global Health |
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13:30 | | Keynote Presentation Nanopore Sequencing for Real-Time Pathogen Identification Kamlesh Patel, R&D Advanced System Engineering and Deployment Manager, Sandia National Laboratories, United States of America
Effective global health response to emergent infectious disease requires a rapidly deployable, universal diagnostic capability. We will present our ongoing work to develop a fieldable device for universal bacterial pathogen characterization based on nanopore DNA sequencing. The relative small-size, portability, long-read lengths, and real-time informatics makes this commercially available technology a game-changer for bacterial pathogen identification. We will present our latest results in integrating a microfluidic front-end for rapid sample preparation and a unique bioinformatics strategy for sequencing the entire 16S to 23S ribosomal DNA locus for species level identification. |
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14:00 | | Keynote Presentation Tackling Global Health Issues Using a Simple Saliva Test Chamindie Punyadeera, Associate Professor, Institute of Health and Biomedical Innovation, Queensland University of Technology, Australia
There is increasing evidence linking oral health to systemic diseases. As such, human saliva is gaining momentum as a diagnostic fluid for the future. Saliva is an ideal diagnostic medium due to the ability to collect it non-invasively. We have been investigating the utility of saliva in diagnosing heart failure patients, and have detected cardiac specific NT-proBNP proteins in saliva (76.8 pg/mL), as well as cardiac troponin-I. The common acute phase inflammatory protein, C Reactive Protein, was also detected in saliva from controls (285 pg/mL) and in cardiac patients (1680 pg/mL) (p<0.01). Oral cavity cancers are more prevalent in emergent economies, whereas the incidence of oropharyngeal cancers is rapidly increasing in the western world. About 50% of these patients die within five years of initial diagnosis due to high burden, aggressive disease and intensive treatment. Diagnostics tools for early detection of these head and neck cancers (HNCs) are desperately needed, in order to reduce disease and treatment-related mortality and morbidity. DNA methylation changes are a hall mark of tumorigenesis. In this study, we have measured DNA methylation levels of RASSF1, p16INK4a, TIMP3, PCQAP 5’ and PCQAP 3’ in healthy control and HNC patient saliva. The results obtained with this particular panel indicate a sensitivity of 71% and a specificity of 80% in discriminating healthy controls (n=122) from HNC patients (n=133). A separate panel measuring nine salivary miRNA biomarkers demonstrated a sensitivity of 95% and a specificity of 93% (AUC = 0.98) when discriminating HNC patients (n=100) from pre-cancer patients (n=29). Significant salivary miRNA changes were observed when detecting patients with early stage tumours vs patients with advanced stage tumours, highlighting the potential clinical utility as a screening tool. In addition, we have also developed a non-invasive method to detect human papillomavirus (hpv-16) in salivary oral rinses; with our test showing a sensitivity of 90% and specificity of 100%. The non-invasive and simple, rapid nature of saliva collection, coupled to serial sampling and cost-effectiveness, makes saliva as an attractive biological fluid for both emerging and developed world. Expansion and implementation of saliva testing for cancer and heart failure provides a window of opportunity for earlier interventions and prevention strategies. |
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14:30 | | Keynote Presentation Rapid Sample to Answer Antibiotic Susceptibility Testing for Bacteremia Alexis Sauer-Budge, Biotechnology Managing Scientist, Exponent, Inc., Adjunct Research Assistant Professor, Biomedical Engineering Dept, Boston University, United States of America
Disease causing microbes that have become resistant to drug therapy are an increasing public health problem. Factors contributing to the rise in antibiotic resistance include widespread and inappropriate prescription of broad-spectrum antibiotics and patient non-compliance to antibiotic regimens. Bloodstream infections, which can lead to sepsis are of particular concern as they represent a serious and growing health burden (9% of all deaths in the US). Despite exhaustive research and development into rapid diagnostics, the leading technologies still require significant time from blood draw to susceptibility results. The major challenge of diagnosing blood-borne pathogens and prescribing the appropriate antibiotic is that the microbes are present in low concentrations in blood (often 10 CFU/mL). Hence, amplification and isolation of the pathogens prior to drug susceptibility testing is required. This talk will describe a novel and rapid sample preparation methodology that efficiently isolates microorganisms directly from whole blood and entirely circumvents the need for traditional blood culture. The process takes about 30 min and maintains the viability of the pathogens for downstream live processing while reducing the 10 mL blood sample into a less than 30 µL volume. Additionally, we have developed a microfluidic platform with which we have shown that shear stress can cause irreparable damage to susceptible but not resistant strains. Thus, we are able to accurately assign antibiotic susceptibility profiles without waiting for bacterial growth (entire assay 1-2.5 h depending on the antibiotic tested). |
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15:00 | Afternoon Coffee Break in the Exhibit Hall |
15:45 | Technology Spotlight: Design and Development of Appropriate Field Deployable Lateral Flow Immunoassay Systems Brendan O' Farrell, President, DCN Diagnostics
Lateral flow technology has evolved to where these devices can be designed to serve the full spectrum of application requirements. In this presentation, the design of high performance lateral flow devices for any application are discussed. The principles of user centric cassette and sample application device design, the architecture of the assay and the manufacturing processes will be discussed and illustrated using case studies of successfully deployed products developed for DCN’s client base. |
16:15 | Technology Spotlight: Optimizing POC Development through Design, Usability and Clinical Research John Zeis, CEO, Toolbox Medical Innovations
Toolbox Medical Innovations brings the unique advantage of offering engineering and product development services combined with a full clinical research and usability organization. These respective disciplines and services directly complement one another enabling optimized products, technologies and solutions. |
16:45 | Highly Integrated Sample-to-Answer Microfluidic Cartridges for Diagnostic and Life Science Applications Holger Becker, Chief Scientific Officer, Microfluidic ChipShop GmbH
In order to generate true “lab-on-a-chip” devices which contain a fully integrated diagnostic workflow from sample-in to result-out, specific strategies during development and for manufacturing. This talk will highlight the specifics of such integrated cartridge product development and solutions for scalable manufacturing including reagent storage and valving. |
17:15 | | Keynote Presentation Feasibility of Specimen Collection by Non-Specialists, Including Patients, at the Point-of-Care Ellen Jo Baron, Executive Director, Medical Affairs, Cepheid, United States of America
How can specimen procurement be simplified to take advantage of the expanding number of simple platforms able to perform fast molecular tests at the point of care? Successes in self-collected vaginal swabs for sexually-transmitted infections and HPV, reliability of fingerstick samples for HIV and HCV viral load, and other potential POC or alternative patient location collection systems will be presented. |
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17:45 | Networking Cocktail Reception with Beer, Wine and Appetizers in the Exhibit Hall. Engage with Colleagues and Visit the Exhibitors |
19:30 | Close of Day 2 of the Conference. |