Cambridge Healthtech’s 3rd Annual

Emerging Technologies at the Point-of-Care

Enabling Clinicians with Cutting Edge Technology to Improve Patient Health Outcomes at the Point-of-Care

August 21-22, 2019

 

Point-of-care testing (POCT) allows clinicians to make rapid decisions to improve clinical outcomes, cost and patient satisfaction. Join us at Emerging Technologies at the Point-of-Care as we discuss the newest technologies in the fastest growing sectors of diagnostics to improve clinical care and their path to clinical use.

Final Agenda

WEDNESDAY, AUGUST 21

10:30 am Registration


11:30 Plenary Keynote Session

11:30 Chairperson’s Remarks

Charles Mathews, Principal, ClearView Healthcare Partners

 

 

 

 

 

11:40 Plenary Keynote Presentation: FDA Updates: Now and Looking to the Future

Tim Stenzel, MD, PhD, Director, Office of In Vitro Diagnostics and Radiological Health, Center for Devices and Radiological Health, U.S. Food and Drug Administration

Introduction and background of the new Office Director of OIR and updates on precision medicine and other initiatives at the FDA.

12:10-1:05 pm Plenary Keynote Discussion: Proposals and Solutions for Diagnostic Reform Including Oversight of Laboratory Developed Tests (LDTs)

Moderator:
Cynthia A. Bens, Senior Vice President, Public Policy, Personalized Medicine Coalition

 

 

 

 

  • How are stakeholders influencing congressional activity on the Verifying Accurate Leading-edge IVCT Development (VALID) Act?
  • How will the VALID Act change the current oversight landscape for diagnostics, including LDTs?
  • How are policymakers addressing the role of CMS and CLIA in the VALID Act?
  • How will increased regulatory and oversight activities at the FDA affect the diagnostics industry?
  • What impact will changes in diagnostics regulation and oversight have on patient care?

Panelists:

Julie Khani, MPA, President, American Clinical Laboratory Association (ACLA)

 

 

 

 

 

Donald E. Horton, Jr., Senior Vice President, Global Government Relations & Public Policy, Laboratory Corporation of America Holdings

 

 

 

 

 

Susan Van Meter, Executive Director, AdvaMedDx

 

 

 

 

 

1:05 pm Luncheon Presentation (Sponsorship Opportunity Available) or Enjoy Lunch on Your Own

1:35 Ice Cream & Cookie Break in the Exhibit Hall with Poster Viewing


KEYNOTE PANEL SESSION:

WHAT MAKES EMERGING TECHNOLOGY ATTRACTIVE?

2:05 Chairperson’s Opening Remarks

David Deetz, Co-Founder, CTO, Ativa Med

2:10 Keynote Panel Discussion: What Makes Emerging Technology Attractive?

Moderator: David Deetz, Co-Founder, CTO, Ativa Med

Panelists: Manish Deshpande, PhD, Vice President, R&D, Point of Care BU, Siemens Healthcare

Prasad V. A Pamidi, PhD, Director, Sensor Development, R&D, Instrumentation Laboratory, A Werfen Company

Matt Bates, Head of R&D, Abbott

Nina Menezes, Head, Marketing Innovation, Abbott

  • Analysis of the latest trends in lab testing
  • Identification of hot new tests and the value they create
  • Creating new uses for established tests by adding in new tech

3:40 Sponsored Presentation (Opportunity Available)

4:10 Refreshment Break in the Exhibit Hall with Poster Viewing

ADVANCING POINT-OF-CARE WITH CONNECTIVITY

4:55 Chairperson’s Remarks

Matt Quinn, MBA, Senior Advisor, Health Technology, HRSA

5:00 Advancing Use of Innovative Health Technologies in the Safety Net

Matthew_QuinnMatt Quinn, MBA, Senior Advisor, Health Technology, HRSA

The Health Resources and Services Administration (HRSA), an agency of the U.S. Department of Health and Human Services, is the primary federal agency for improving healthcare to people who are geographically isolated, economically or medically vulnerable. This session will describe how HRSA advances the use of health technologies to achieve its mission of improving health and achieving health equity through access to quality services, a skilled health workforce and innovative programs.

5:30 Smart and Connected Molecular Diagnostics at the Point-of-Care

Liu_ChangchunChangchun Liu, Associate Professor, Biomedical Engineering Department, University of Connecticut, UConn Health

Smartphones have a growing and pervasive influence on our daily life. Especially, with the rapid development of microfluidics technology, the incorporation of microfluidics technology with smartphone-based detection technology will create a new paradigm shift towards affordable, smart and connected health monitoring. In this talk, I will introduce our synergistically enhanced colorimetric molecular detection method, molecular diagnostic chips, smart connected systems and their applications in early cancer screening (e.g., HPV-associated cancer) and infectious disease detection (e.g., Zika virus, HIV virus) at the point-of-care.

6:00 Q-POC – Molecular Diagnostics Point-of-Care 2.0

oHalloran_JonathanJonathan O’Halloran, CSO, QuantuMDx Group Ltd

QuantuMDx has developed a novel, low-cost sample to answer molecular diagnostics device aimed at both low and high resource settings. The device performs both qPCR and end-point PCR followed by a microarray, all within a single ultra-low-cost disposable. The company’s first assay is an HPV assay, due for launch in 2020, that individually genotypes 13 high-risk sub-types of the virus, directly from a swab sample in under 30 minutes.

6:30 Close of Day

6:30 Dinner Short Course Registration


6:45 - 9:15 pm Recommended dinner Short Course*

SC15: Microfluidics and Lab-on-a-Chip Devices for POCT: Technologies and Commercialization

Myatt_ChrisChris Myatt, Founder & CEO, MBio Diagnostics, Inc.

Additional Speakers to be Announced

This short course will provide an overview of microfluidic techniques, including valved and valve-less devices, pumped systems, and capillary flow approaches. Practical examples will keep the discussion grounded in the realization of commercializable devices. We will discuss engineering approaches to enhance the advantages and minimize the challenges. Throughout, the science will be linked to the commercial case for these devices, including a full discussion of a recent success story of a centrifugal microfluidic molecular assay system.

*Separate registration required.

thursDAY, AUGUST 22

7:15 am Registration


7:30 Problem Solving Breakout Discussions with Continental Breakfast

Validating New POCT TEchnologies

8:25 Chairperson’s Remarks

Jonathan O’Halloran, CSO, QuantuMDx Group Ltd

8:30 Clinical Needs, Validation and Implementation Strategies for Novel Point-of-Care Technologies

Wang_PingPing Wang, PhD, DABCC, Chief, Clinical Chemistry, Director, Core Laboratory Hospital of University of Pennsylvania

The field of point-of-care technologies has witnessed strong growth, as evidenced by new clinical or consumer products, or research and development directions. Only when combined with appropriate strategies for clinical needs assessment, validation and implementation, these technologies may significantly impact care delivery and associated outcomes and costs. In this presentation, I will discuss clinical needs, validation and implementation strategies for novel point-of-care technologies from two perspectives: as a practicing clinical laboratory director, and as a technology researcher and developer.

9:00 Diagnostic Workstation: A New Approach to Diagnosing Primary-Care Patients Enables New Processes

Deetz_DavidDavid Deetz, Founder, CTO, Ativa Med

Ativa’s Diagnostic Workstation integrates a synergistic array of breakthrough diagnostic and AI technologies that has the potential to disrupt the current process of primary care because it facilitates:


  • Much faster diagnoses - It permits healthcare personnel to run the major blood/urine panels immediately themselves, which enables the provider to diagnose a patient within moments, rather than hours or days
  • Improved diagnoses – Its cloud-based AI enables protocol-driven test selection and provides meaningful interpretation to improve diagnoses
  • Expanded ability to detect serious diseases in primary care

9:30 Sponsored Presentation (Opportunity Available)

10:00 Coffee Break in the Exhibit Hall with Poster Viewing

LATERAL FLOW IMMUNOASSAYS AND PAPER DIAGNOSTICS

11:00 Chairperson’s Remarks

Karl Poterack, MD, Medical Director, Applied Clinical Informatics, Mayo Clinic

11:05 Catalytic Nanoparticles as Labels in Lateral Flow Immunoassays

Mulvaney_ShawnShawn Mulvaney, PhD, Section Head, Surface Nanoscience and Sensor Technology Section, Chemistry, US Naval Research Laboratory

Lateral-flow immunoassays (LFIs of LFIAs) are widely used point-of-care technology. Visually-read, LFIAs typically use colloidal gold or colored latex as the reporter elements for the antibody-antigen binding event. Due to their visual extinction coefficients, the intensity of these labels are limited which ultimately limits the sensitivity of the assay. We have substituted specially-prepared, colloidal palladium for the traditional labels and use it as a chemical catalyst to produce an easily-observable, stable, blue dye that localizes at the capture line. Importantly, the catalyst is heat stable, functions at room temperature, under physical conditions, and results in up to a 500-fold increase in sensitivity with only five additional minutes of development.

11:35 Paper Devices for Medical Self-testing at Home: Opportunities and Challenges

Christodouleas_DionysiosDionysios Christodouleas, PhD, Assistant Professor, Department of Chemistry, University of Massachusetts Lowell

Diagnostic devices for home use should operate with minimal user involvement, be able to analyze untreated samples, and have low cost. Paper devices are inexpensive and, if they are designed carefully, could be capable of analyzing untreated samples and be fully integrated. In this presentation, I will discuss examples of paper devices that allow biochemical testing without user involvement and point toward areas of future research in paper diagnostics to address current challenges.


12:05 pm Paper-Based Surface-Enhanced Raman Scattering Lateral Flow Strips for Point-of-Care Applications

Wu_NickNianqiang (Nick) Wu, Professor, Mechanical and Aerospace Engineering, West Virginia University

This presentation will present our effort to develop plasmonic nanostructures for amplifying surface-enhanced Raman scattering (SERS) signals. It will also show how to incorporate SERS sensors into paper-based lateral flow strips (PLFS) as point-of-care tools. The PLFS is composed of the on-chip sample pretreatment, flow control and detection components. Moreover, this talk will demonstrate measurement of the traumatic brain injury (TBI) protein biomarkers in clinical samples by the SERS-based PLFS.

12:35 Sponsored Presentation (Opportunity Available)

1:05 Luncheon Presentation (Sponsorship Opportunity Available) or Enjoy Lunch on Your Own

1:35 Dessert Break in the Exhibit Hall with Poster Viewing

DEVELOPING APPS FOR DIAGNOSTICS

2:15 Chairperson’s Remarks

Wilbur A. Lam, MD, PhD, Associate Professor, Wallace H. Coulter Department of Biomedical Engineering and Department of Pediatrics, Aflac Cancer and Blood Disorders Center of Children’s Healthcare of Atlanta, Georgia Institute of Technology and Emory University School of Medicine

2:20 AMA Guideline’s on Mhealth Apps

Michael L Hodgkins, MD, MPH, Chief Medical Information Officer, AMA

2:50 Development of a Smartphone App for Non-Invasive Detection of Anemia Using Only Patient-Sourced Photos

Lam_WilburWilbur A. Lam, MD, PhD, Associate Professor, Wallace H. Coulter Department of Biomedical Engineering and Department of Pediatrics, Aflac Cancer and Blood Disorders Center of Children’s Healthcare of Atlanta, Georgia Institute of Technology and Emory University School of Medicine

We introduce a paradigm of non-invasive, on-demand diagnostics for hematologic diseases using only a smartphone app and photos. We initially targeted anemia, characterized by low blood hemoglobin levels, which afflicts >2 billion people. Our app estimates hemoglobin levels by analyzing color and metadata of fingernail smartphone photos and screens for anemia (hemoglobin levels <12.5 g/dL) with a 97% sensitivity (n = 100 subjects). Moreover, with personalized calibration, this system achieves an accuracy of ±0.92 g/dL compared to gold standard hemoglobin levels (n = 16 subjects), empowering chronic anemia patients to serially monitor their hemoglobin levels instantaneously and non-invasively.

FUTURE ASPECTS OF CLINICAL DX - WEARABLES AND BEYOND

3:20 Wearable Monitors in Health Care: Signal or Noise?

poterack_karlKarl Poterack, MD, Medical Director, Applied Clinical Informatics, Mayo Clinic

Widely used wearable devices like activity trackers and smart watches continuously measure physiologic data during everyday activities. Utilizing this data requires a paradigm shift for health care, since traditionally this data was only collected during patients’ healthcare visits. This presentation will cover the types of data that can be collected, the associated technical challenges, as well as the system changes required in order to be able to utilize this data to improve care and outcomes.

3:50 Future Trends in POC Diagnostics

Sackrison_JimJim Sackrison, Consultant

This talk will discuss the future trends in POC diagnostics and where the field may be in the next 5, 10, 20 years.


4:20 End of Summit