Cambridge Healthtech Institute’s Eleventh Annual
Enabling Point-of-Care Diagnostics
Delivering Rapid Results to Improve Outcomes
August 15-16, 2017 | Grand Hyatt Washington | Washington, DC
Developing rapid diagnostics that are easy to use and provide sample to answer solutions is a growing trend that will have significant impact on infectious disease outbreaks, global health, and diabetes monitoring, to name just a few applications. The combined power of microfluidics and smartphone technologies will result in a revolution not just in diagnostics, but in our understanding and treatment of disease. Non-invasive testing is transforming the clinical world by providing a means of early detection and monitoring of disease through the development of innovative and efficient healthcare delivery systems, and enabling a closed-loop system where rapid detection directly connects with a treatment regimen.
Final Agenda
Scientific Advisory Board
Holger Becker, Ph.D., Founder & CSO, microfluidic ChipShop GmbH
John C. Carrano, Ph.D., President & CEO, Paratus Diagnostics LLC
Eric van Gieson, Ph.D., Professor, University of Nebraska Medical Center
James H. Nichols, Ph.D., DABCC, FACB, Professor, Pathology, Microbiology and Immunology; Medical Director, Clinical Chemistry; Medical Director, POCT, Vanderbilt University School of Medicine
Recommended Short Course(s)*
SC3: Technologies, Applications and Commercialization of Point-of-Care Diagnostics
SC6: Rapid Diagnostics for Antimicrobial Resistance
*Separate registration required
TUESDAY, AUGUST 15
7:30 am Main Conference Registration & Morning Coffee
8:30 Chairperson’s Opening Remarks
James H. Nichols, Ph.D., DABCC, FACB, Professor, Pathology, Microbiology and Immunology; Medical Director, Clinical Chemistry; Medical Director, POCT, Vanderbilt University School of Medicine
8:40 KEYNOTE PRESENTATION: Consumer Laboratory Testing: Risks and Prevention
James H. Nichols, Ph.D., DABCC, FACB, Professor, Pathology, Microbiology and Immunology; Medical Director, Clinical Chemistry; Medical Director, POCT, Vanderbilt University School of Medicine
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? This presentation will cover the risks and errors that can occur with consumer diagnostics and ways that patients can ensure quality.
9:10 Reflections on Appropriate Studies to Validate Point-of-Care and Over-the-Counter Diagnostics
Alberto Gutierrez, Ph.D., Director, Office of In Vitro Diagnostics and Radiological Health, Food and Drug Administration
A discussion of the requirements under the Food Drug and Cosmetic Act and Clinical Laboratory Improvement Act will be presented and the speaker will explore available options including the traditional path of stepwise FDA clearance/approval followed by CLIA waiver, or whether a dual simultaneous path might create valuable time and study efficiencies. Similarly, the type of studies that are necessary for over-the-counter tests will be discussed.
9:40 POCT Diagnostics: What Is Missing and What Can Improve?
William Clarke, Ph.D., MBA, DABCC, Associate Professor, Pathology, Johns Hopkins School of Medicine
In this lecture, we will discuss the current state of POCT and where improvements can be made to increase the quality of results and positively impact patient outcomes. In addition, we will discuss where there are gaps in the technology relative to currently available POCT devices and assays. Lastly, we will discuss emerging technology that may become POCT products in the future.
10:10 Coffee Break in the Exhibit Hall with Poster Viewing
Chairperson’s Remarks
Cece O'Connor, Global Director, UX Strategy & Design, Invetech
11:00 The Role of the Pharmacist in Point-of-Care Testing
Donald G. Klepser, Ph.D., MBA, Associate Professor, Pharmacy Practice, College of Pharmacy, University of Nebraska Medical Center
Community pharmacists are uniquely accessible amongst health care providers. Community pharmacies provide CLIA-waived point-of-care testing (POCT) services under a number of different models. Recent research and regulatory changes have expanded the POCT opportunities for pharmacists as part of collaborative disease management programs. This session will describe the different approaches to providing POCT in a pharmacy and discuss the role pharmacists can play in a POCT service.
11:30 A Pilot Study for Detection of Circulating Tumor DNA Using a Hand-Held Diagnostic Testing Device: One Step Closer to Cancer Monitoring from Home?
Andrew H. Ko, M.D., Professor, Clinical Medicine, Division of Hematology/Oncology, Helen Diller Family Comprehensive Cancer Center, University of California, San Francisco
Detection and quantitation of circulating tumor DNA represents a minimally invasive approach that can be used to monitor treatment response and disease progression/relapse in patients with cancer. In this pilot study, a novel diagnostic testing platform developed by Two Pore Guys, consisting of a simple hand-held nanopore sensor device, was used to detect specific KRAS mutations in the blood and urine of patients with solid tumors harboring this target.
12:00 pm A New, Accessible Point-Of-Care Molecular System for Physician Offices
Hong Cai, CEO, Mesa Biotech
Technology keeps changing and the market continues to move towards molecular testing, point-of-care, and near patient testing solutions. In this presentation, Mesa Biotech will talk about its unique, rapid, POC molecular infectious disease testing system. The presentation will include a review of performance and ease of use information from this very accessible palm sized POC system.
12:30 Tips and Pitfalls in the Timely Development of Microfluidic Diagnostics for Real-World Applications
Erol Harvey, Ph.D., CEO, MiniFAB
Driven by the need for fast, convenient results, “consumerisation"of diagnostics is experiencing rapid growth, opening new markets. However poor early design decisions, or a misunderstanding of what really matters to end-users, can result in products that fail in the market place. We will present case studies and discuss lessons learnt.
12:45 A Multiplexed Platform for Point-of-Care Precision Medicine as Applied to Sepsis Diagnostics
Chris Myatt, CEO, MBio Diagnostics, Inc.
Sepsis and acute infections present complex disease states that require precision medicine results in real time. With multiple biomarkers, and often algorithmic approaches to analysis, a multiplex platform is essential to delivering the necessary data on-the-spot. We detail host response biomarker panels with applications in risk stratification and therapy optimization.
1:00 Luncheon Presentation: Designing for Humans in a Rapidly Changing Point-of-Care Ecosystem
Cece O'Connor, Global Director, UX Strategy & Design, Invetech
POC healthcare delivery is complex and evolving. Addressing this rapidly changing environment, IVD manufacturers cannot rely on designs and workflows that were applicable five years ago. Today, successful POCT integration into health systems incorporates a deep knowledge of the people involved. Human-centered experience design can uncover powerful insights into user needs, leading to innovative, intuitive workflows and digital interaction. We will outline how designing for users from the very beginning creates differentiated, successful diagnostic solutions.
1:30 Refreshment and Cookie Break in the Exhibit Hall with Poster Viewing
2:00 Chairperson’s Remarks
Eric van Gieson, Ph.D., Professor, University of Nebraska Medical Center
2:05 Supporting POC Testing with Qualified Relevant Data through Cognitive Support Tools
Todd A. Ritter, Vice President, Federal Solutions, Orion Health
Precision Medicine requires accurate data at the point-of-care and the need for cognitive support tools that locally integrate all available sources of data to provide real-time decisions. Integration tools provide the user the ability to proactively evolve a patient diagnosis before, during, and after patient encounters as new data becomes available. In addition to assessing existing diagnoses, heuristic patterns need to be incorporated into AI-based approaches to drive the use of additional diagnostics (when needed) to support patient care. This AI-based approach becomes especially valuable in austere settings where health professionals may not be available, as in military care situations in deployed settings. The disciplines of machine learning and large data integration will be major components of the most accurate assessment tools in the near future.
2:35 Genomic Sequencing in Clinical Care, When Will We Be There?
Colleen S. Kraft, M.D., Associate Professor, Pathology & Laboratory Medicine, Emory University School of Medicine
The advent of sequencing has revolutionized research and has influenced some clinical care. This talk looks at different platforms and where they are in actually being used for routine patient care in a healthcare setting, the goals, and limitations of this technology in the clinical setting.
3:05 Application of NGS to Real-Time Identification and Tracking of Emerging Infectious Diseases
Marilynn A. Larson, M.Sc., Ph.D., Assistant Professor, NSRI Chem/Bio Countermeasures Research Coordinator, Pathology and Microbiology, University of Nebraska Medical Center
The promise and potential of real -time sequencing is identification of “anything, anywhere, anytime”. Key to achieving that vision is aggregation of software into a complete system that can be operated by non-experts. We will share our strategy and progress toward this goal.
3:35 Design and Development of Appropriate Field Deployable Lateral Flow Immunoassay Systems
Brendan O' Farrell, Ph.D., 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.
4:05 Refreshment Break in the Exhibit Hall with Poster Viewing
4:45 Chairperson’s Remarks
John C. Carrano, Ph.D., President & CEO, Paratus Diagnostics LLC
4:50 KEYNOTE PRESENTATION: The Case for Real-Time Monitoring of Immunotherapy via Continuing Diagnostics
M. Allen Northrup, Ph.D., FRSC, CEO, MIODx
Ideally, a companion diagnostic would be 100% predictive to ensure that a therapy would work. It will save money, time and save patients – at least those that can be selected. As well, in clinical trials, it would be best to eliminate patients that won’t respond, smoothing the path to FDA approval. However, is there a simple gene or other marker to accurately predict a response to a therapy in such a complex and dynamic system as the human immune system? In the absence of a precise and predictive companion diagnostic, to prevent unforeseen negative effects or ineffective treatments, and to understand the immunological response, immunotherapies benefit from real-time patient/therapy monitoring.
5:20 A Point-of-Care Multiplexed Diagnostic Solution for Gastroenteritis in Low-Resource Setting
John C. Carrano, Ph.D., Chairman & CEO, Paratus Diagnostics, LLC
In this paper we will describe our work to develop a reliable, point-of-need diagnostic device that is field-deployable, appropriately sensitive, and specific, and can be easily adapted for detection of a variety of targets associated with gastroenteritis that are of interest to both the industrialized and the developing world.
5:35 Improved Healthcare through Rapid Detection of Sexually Transmitted Infections
John Clarkson, Ph.D., CEO, Atlas Genetics
This presentation will describe the patient, clinician and payor benefits of point-of-care tests for STIs, and discuss how these can be achieved using the Atlas Genetics rapid, fully integrated molecular diagnostics system. Clinical trials are underway for CT/NG, and the pipeline of tests includes Trichomonas, Mycoplasma and antibiotic resistance markers.
5:50 Wine & Cheese Pairing Welcome Reception in the Exhibit Hall with Poster Viewing
6:50 Close of Day
WEDNESDAY, AUGUST 16
7:15 am Registration
7:30 am Problem-Solving Breakout Discussions with Continental Breakfast
These interactive discussion groups are open to all attendees, speakers, sponsors, & exhibitors. Participants choose a specific breakout discussion group to join. Each group has a moderator to ensure focused discussions around key issues within the topic. This format allows participants to meet potential collaborators, share examples from their work, vet ideas with peers, and be part of a group problem-solving endeavor. The discussions provide an informal exchange of ideas and are not meant to be a corporate or specific product discussion.
Molecular Diagnostics at the Point-of-Care and at Home
Haim H. Bau, Ph.D., Professor, Mechanical Engineering and Applied Mechanics (MEAM), School of Engineering & Applied Science, University of Pennsylvania
- Is instrumentation-free molecular detection possible?
- Are biosensors that operate without enzymatic amplification simpler?
- The need for co-detection of multiple targets
Barriers to Point-of-Care Testing in the Community Pharmacy
Donald G. Klepser, Ph.D., MBA, Associate Professor, Pharmacy Practice, College of Pharmacy, University of Nebraska Medical Center
- How do differences in state laws slow implementation point-of-care testing in pharmacies?
- The challenges of finding a willing collaborator for pharmacy-based point-of-care testing
- Moving from an idea to a viable testing service
8:25 Chairperson’s Opening Remarks
Holger Becker, Ph.D., Founder & CSO, microfluidic ChipShop GmbH
8:30 Point-of-Care Screening and Monitoring of Sickle Cell Disease
Peter Galen, CIO, Hemex Health, Inc.
Sickle Cell Disease (SCD) affects 100,000 Americans and more than 14 million people globally, mostly in economically disadvantaged populations, and requires early diagnosis after birth and constant monitoring throughout life. Recently developed microtechnologies offer simple, rapid, and affordable screening of SCD and they may facilitate universal screening in resource-limited settings and developing countries. Use of novel microdevices for patient monitoring are essential in new clinical trial designs of emerging therapies.
9:00 Label-Free Magnetic Levitation Technologies for Monitoring Health and Disease
Utkan Demirci, Ph.D., Professor, Radiology, Canary Center for Cancer Early Detection, Stanford University School of Medicine
Emerging nano-scale and microfluidic technologies integrated with biology offer innovative possibilities for creating intelligent, mobile medical lab-chip devices that could transform diagnostics and monitoring, tissue engineering and regenerative medicine. In this talk, we will present an overview of our laboratory’s work in these areas focused on applications in magnetic levitation methods for assembling cells and label free sorting of rare cells from whole blood.
9:30 Point-of-Care Molecular Detection of Zika Virus and Other Vector-Borne Pathogens
Haim H. Bau, Ph.D., Professor, Mechanical Engineering and Applied Mechanics (MEAM), School of Engineering & Applied Science, University of Pennsylvania
We describe an inexpensive, simple, rapid platform for molecular detection of pathogens at the point-of-care. Our system isolates, concentrates, amplifies, detects, and quantify target nucleic acids and (optionally) interfaces with a smart phone. As a particular example, we describe detection of Zika virus in saliva. Our system can be extended to co-detect multiple pathogens in a sample with our newly developed two-step isothermal amplification strategy.
10:00 Qorvo Biotechnologies Novel Platform for Mobile and Point of Need Applications
Bryan Bothwell, Director- Strategy and Business Development, Qorvo Biotechnologies
Qorvo Biotechnologies has developed a biosensor platform that creates a paradigm shift in point of need testing. By combining novel multi-GHz bulk acoustic wave detection arrays with microfluidics and electronics integration, centralized lab results at the true point of need are enabled- breaking the technological barrier limiting ubiquitous deployment of liquid-based biosensors across all markets. Sample flexibility and performance across both Immunoassays and Molecular Dx make this a truly universal platform.
10:30 Coffee Break in the Exhibit Hall with Poster Viewing
1:05 pm Luncheon Presentation:10x Faster: Defeating the Universal Challenge of Microfluidic Mixing
Richard Spero, Ph.D., CEO, Redbud Labs
Sooner or later, virtually every next-generation point-of-care diagnostic will struggle with microfluidic mixing. This talk will explore the markets and methods where this humble technical challenge is the gating factor in commercial success. Mixing is key to achieving specifications like time-to-result, analytic precision, and limit of detection. We review the science that governs this design space, then survey generic solutions that can be combined with practical cartridge manufacturing and assembly methods.
1:35 Ice Cream and Cookie Break in the Exhibit Hall with Poster Viewing
1:35 Close of Enabling Point-of-Care Diagnostics