Point-of-Care and Mobile Health Diagnostics Technologies
Point-of-Care and Mobile Health Diagnostics Clinical-Consumer Interface
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The fastest-growing segment of the IVD market is point-of-care testing, and the abundance of health apps for mobile devices will vastly change how healthcare is delivered. The opportunity for remote monitoring, measuring drug response, tools for drug development and companion diagnostics have not been fully exploited but promise to offer unlimited new possibilities. Areas to be watched include molecular diagnostics at the point-of-care and management of chronic or infectious disease. Cambridge Healthtech Institute’s “Part 1: Point-of-Care and Mobile Health Diagnostics Technologies: Molecular Diagnostics, Sensors, Disease Management” will address how rapid testing can enable improved clinical decision making and quality of care while lowering the cost of healthcare. Advances are changing the current treatment paradigm for cardiac, HIV, influenza, and a spectrum of infectious disease testing. Hear experts discuss the landscape of point-of-care testing and the tools being developed to change healthcare delivery.
Scientific Advisory Board
Avraham Rasooly, Ph.D., Program Director, National Cancer Institute, NIH
Gerald J. Kost, M.D., Ph.D., MS, Professor, Pathology and Laboratory Medicine; Director, Clinical Chemistry and Point-of-Care Testing; Faculty, Biomedical Engineering and Comparative Pathology, University of California, Davis
TUESDAY, NOVEMBER 4
11:00 am -12:00 pm Short Course Registration
12:00- 5:00 pm WS: Commercialization Boot Camp: Manual for Success in Diagnostics*
4:00 - 6:00 pm Main Conference Registration
5:30 - 8:00 pm SC1: Technologies and Applications for Point-of-Care Testing for Infectious Disease*
*Separate registration required
WEDNESDAY, NOVEMBER 5
7:15 - 8:15 am Registration & Morning Coffee
8:15 Conference Director’s Welcome Remarks
8:20 Chairperson’s Opening Remarks
Gerald J. Kost, M.D., Ph.D., MS, FACB, Professor, Pathology and Laboratory Medicine; Director, Clinical Chemistry and Point-of-Care Testing; Faculty, Biomedical Engineering and Comparative Pathology, University of California, Davis
8:30 KEYNOTE PRESENTATION
Developing Miniature Imaging Systems to Enable Better Screening for Oral, Esophageal, and Cervical Cancer at the Point-of-Care in Low Resource Settings
Rebecca Richards-Kortum, Ph.D., Stanley C. Moore Professor & Chair, George R. Brown School of Engineering, Rice University
This talk will describe efforts to engineer appropriate high-performance, low-cost biophotonics technologies to identify cancer and precancer at a stage where it can be treated in low-resource settings. We will describe results of clinical studies in the US, China, Brazil, and Botswana.
9:00 Low Cost Point-of-Care Detection Technologies
Hugh A. Bruck,Ph.D., Professor, Mechanical Engineering, University of Maryland
This presentation will review the various prototypes of low-cost optical technologies that have been developed at the FDA’s Office of Science and Engineering laboratories and the University of Maryland Multi-scale Measurements Laboratory. The following four technologies will be discussed, for example(1) a webcam-based multi-wavelength fluorescence plate reader, (2) a lens-free optical detector (3) a Lab-on-a-chip (LOC), and (4) a wide-field flow cytometer.
9:30 Implementing Point-of-Care Testing to Improve Outcomes in Primary Care
Kent Lewandrowski, M.D., Associate Chief, Pathology; Director, Pathology Laboratories and Molecular Medicine, Massachusetts General Hospital; Professor, Pathology, Harvard Medical School
Point-of-care testing (POCT) offers reduced turnaround time and facilitates more timely medical decision making. Improved outcomes resulting from POCT may include better medical outcomes, financial outcomes and outcomes resulting from improved clinical operations. Primary care practices are facing increasing challenges relating to decreased reimbursement, pay for performance insurance contracts and increasing patient case loads. POCT offers one strategy to help alleviate these pressures. This presentation will review the literature on POCT in improving outcomes in primary care. We will also present data from at study at the Massachusetts General Hospital utilizing POCT in a primary care practice.
10:00 Coffee Break in the Exhibit Hall with Poster Viewing
CANCER MANAGEMENT AT THE POINT-OF-CARE
10:40 Chairperson’s Remarks
Avraham Rasooly, Ph.D., Health Scientist Administrator, Division of Cancer Treatment and Diagnosis, National Cancer Institute
10:45 Clinical Challenges and the Point-of-Care Needs in Breast Cancer Diagnosis
Jane E. Brock, MBBS, Ph.D., Assistant Professor, Harvard Medical School; Medical Director, Surgical Pathology Grossing Room; Associate Pathologist, Brigham & Women’s Hospital, Dana Farber Cancer Institute and Harvard Medical School
Breast cancer is a heterogeneous disease comprising different histological types with different responses to therapy and outcome requiring tailoring of treatments. POC diagnostic needs include rapid histopathologic diagnosis, provision of the current traditional prognostic factors such as tumor grade, ER, PR and Her2 status needed to guide treatment, and in the near future, evaluation of sensitivity/resistance information to treatment regimens and tracking of disease burden.
11:15 Smart Handheld Devices to Screen Melanoma and Other Skin Lesions
George Zouridakis, Ph.D., Professor, Engineering Technology, Electrical & Computer Engineering, Computer Science, University of Houston
Modern smartphones and tablets featuring multicore processors, dedicated microchips for graphics, high-resolution cameras, and wireless communication can run sophisticated software very fast. Such devices empower clinicians to make timely and accurate point-of-care diagnoses, while patients are treated in a more comfortable and less costly setting alternative to hospitalization. We present a smartphone digital dermoscopy application for screening melanoma and Buruli ulcer, a flesh-eating bacterial disease.
11:45 Sponsored Presentation (Opportunity Available)
12:15 pm Luncheon Presentations (Sponsorship Opportunities Available) or Enjoy Lunch on Your Own
1:15 Session Break
1:35 Point-of-Care Ultrasound Scanner for Breast Cancer Imaging
Paul E. Barbone, Ph.D., Professor, Theoretical Acoustics & Applied Mechanics, Mechanical Engineering, Boston University
New developments in ultrasound (US) imaging, especially elastography, have made US more useful than ever before in breast cancer imaging applications. Enabling this technology on point-of-care (POC) laptop platforms would make it available to low-resource communities. In this presentation, we discuss the potential role of POC US with advanced elastography capabilities in breast cancer management in diverse low-resourced settings.
2:05 Cancer Care at the Point-of-Care
Catherine Klapperich, Ph.D., Associate Professor, Biomedical Engineering; Director, NIBIB Center for Future Technologies in Cancer Care, Boston University
To address the current issues that (cancer) patients face in low resource settings in the developing world, the Center is focusing on the identification, prototyping and early clinical assessment of innovative point-of-care technologies for the treatment, screening, diagnosis and monitoring of cancers. This talk will address how our integrated multidisciplinary team, consisting of engineers, clinicians, public health practitioners, and technology transfer experts, is currently evaluating technologies in various stages of development for suitability across a range of primary care and non-traditional healthcare settings.
2:35 A Portable, Low Cost 3D Mechano-Transduction Mapping Device for Solid Tumor Detection
James K. Gimzewski, Ph.D., Ph.D. hc, DSc hc, FRS FREng, Distinguished Professor, Chemistry & Biochemistry, University of California, Los Angeles
Tissue biomechanics and heterogeneity may be a quantitative marker to predict the behavior of solid tumors such as breast and thyroid. I will provide an overview of our work on single cell/tissue cancer mechanics as well as introduce ongoing research on a portable, low cost, piezosensing FNE (Fine Needle Elastography) device to be used for profiling the biomechanics and tissue heterogeneity in tissues ex vivo.
3:05 Sponsored Presentation (Opportunity Available)
3:35 Refreshment Break in the Exhibit Hall with Poster Viewing
IMAGING TECHNOLOGIES AT THE POC
4:10 Chairperson’s Remarks
4:15 Portable Ultrasound in Remote, Resource-Poor, Disaster, and Emergency Settings
Anthony J. Dean, M.D., FAAEM, FACEP, Associate Professor, Emergency Medicine in Radiology; Director, Division of Emergency Ultrasonography, Department of Emergency Medicine, University of Pennsylvania Medical Center
Technical advances in the design and manufacture of ultrasound (US) equipment have resulted in the development of lightweight, battery-operated devices that produce high-quality images. Portability allows ultrasonography to be used in environments where no other imaging is available: for triage, evacuation decision-making, field management, and guidance for invasive procedures. A burgeoning body of literature is resulting in rapid improvement in the IT and infrastructural requirements for ultrasound by inexperienced operators telemedically guided by experts.
4:45 PANEL DISCUSSION: THE STATUS OF HOSPITAL POC TESTING AND ITS REGULATION
With the pending CMS ruling to outlaw POC glucose meters in hospitals as off-label use, unless operated as high complexity devices, there is interest in understanding the future of POCT regulation and the impact on hospitals. This panel will review the status of high complexity devices and regulation policies.
Moderator: Jeffrey A. DuBois, Ph.D., Vice President, Medical & Scientific Affairs, Nova Biomedical
Panelists: Marcy Anderson, Director, Development & Education, Clinical and Laboratory Standards Institute (CLSI)
Additional Panelists to Be Announced
5:45 Welcome Reception in the Exhibit Hall with Poster Viewing
6:45 Close of Day
THURSDAY, NOVEMBER 6
7:45 - 8:25 am Morning Coffee
MEASURING PHYSICAL AND PHYSIOLOGICAL PARAMETERS
8:25 Chairperson’s Opening Remarks
8:30 Options for Intermittent and Continuous Atrial Fibrillation Monitoring
Ki H. Chon, Ph.D., Professor & Head, Biomedical Engineering, Worcester Polytechnic Institute
We developed a smart phone application to measure heart rate interval series which can be used intermittently to detect AF in real time. For continuous monitoring of paroxysmal AF, we developed a wearable device with reusable ECG electrodes with a smart phone as a medium for data transfer. Hence, the seminar will discuss the development and clinical testing of both intermittent and continuous monitoring of AF.
9:00 Micro- and Nano-Scale Technologies for Applications in Medicine at the Point-of-Care
Utkan Demirci, Ph.D., Associate Professor, Medicine, Canary Center for Cancer Early Detection, Stanford University
In this talk, we will present an overview of our laboratory’s work in these areas focussed on applications in point-of-care and primary care settings including applications for ovarian cancer detection from urine, rapid CD4 counts for global health, multiple pathogen detection with a focus on viral load from unprocessed whole blood and bedside peritonitis detection for end-stage kidney disease patients going through peritoneal dialysis therapy. These emerging technologies could shape our future creating broadly applicable platforms for scientific discovery, providing clinical solutions for resource-constrained settings in the developing world as well as for primary care settings in the developed world.
9:30 Coffee Break in the Exhibit Hall with Poster Viewing
MOLECULAR DIAGNOSTICS AT THE POINT-OF-CARE
10:10 Chairperson’s Remarks
Miguel Ossandon, MS, Program Director, Cancer Diagnosis Program, Division of Cancer Treatment and Diagnosis, National Cancer Institute, NIH
10:15 Moving Molecular Diagnostics to the Point-of-Care
This presentation addresses sepsis, a challenge for molecular diagnostics. Learning objectives are to: define sepsis and the impact of bloodstream infections; introduce sepsis biomarkers, trend mapping, and algorithmic decision-making; compare/contrast molecular systems; address unmet needs; and understand potential impact of technologies on patient outcomes. We conclude that molecular systems focusing on early holistic diagnosis, management, and treatment, and new POC formats soon will make rapid response a reality in critically care.
10:45 A Handheld Point-of-Care Genomic Diagnostic System for HIV Detection
Luke P. Lee, Arnold and Barbara Silverman Distinguished Professor Bioengineering, Electrical Engineering & Computer Science, and Biophysics, University of California Berkeley
In this talk, I will present our integrated molecular diagnostic system (iMDx) for POC and mobile digital healthcare. The iMDx comprises a self-contained sample preparation from whole blood, multiplexed protein assays, and ultrafast nucleic acid amplification assays on chip with a sample-to-answer readout platform. Additionally, the iMDx features cell phone data connectivity and GPS sample geotagging, which can enable epidemiological surveying and remote healthcare delivery.
11:15 Point-of-Care Smartphone Detection of Salmonella
Jeong-Yeol Yoon, Ph.D., Associate Professor, Agricultural & Biosystems Engineering, Animal & Comparative Biomedical Sciences, and Biomedical Engineering, The University of Arizona
We report the use of 1) paper microfluidics and the smartphone-based optical detection towards food, water and medical applications, 2) droplet microfluidics (called “wire-guided droplet manipulations - WDM”) towards in situ monitoring of bloodborne pathogens and endocarditis, and 3) microfluidic-based, continuous bioreactor that will be seeded with mammalian (mostly human) cells, towards creating mock-up human organs (organ-on-a-chip).
11:45 Technology Challenges and Opportunities in POC and mHealth for Cancer Detection and Diagnosis in Low Resource Settings
Development in consumer electronic devices, microfabrication, cellular phone and hand-held devices has resulted in an explosion of POC and mHealth technologies. Due to the mobile nature, portability and potentially low cost, these technologists play an important role in low resource areas. However, development of POC/mHealth applications for cancer is lagging due in part to the complex nature of cancer. This talk will focus on the challenges of mHealth and POC technologies for cancer in low resource settings.
12:15 pm Close of Conference
Join us for PART 2 on Thursday and Friday: Point-of-Care and Mobile Health Diagnostics Clinical-Consumer Interface.
For questions or suggestions about the meeting, please contact:
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Part 1: Technologies
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