The need for faster turnaround and greater accuracy is driving adoption of next generation tests for infectious disease. The Inaugural Advanced Diagnostics for Infectious Disease conference will highlight trends in developing innovative tests and their
adoption that will directly impact patient outcomes and reduce costs in healthcare delivery. It will cover molecular diagnostics, point-of-care testing and sequencing of pathogens, as well as mass spec and genome analysis.
WEDNESDAY, 15 APRIL
13:00 Chairperson’s Opening Remarks
Gyorgy Abel, M.D., Ph.D., Director, Molecular Diagnostics, Immunology & Clinical Chemistry, Laboratory Medicine, Lahey Hospital & Medical Center, United States
»13:05 KEYNOTE PRESENTATION: A Paradigm Shift of Diagnostic Medical Microbiology: Will it Finally Happen?
Herman Goossens, Ph.D., Professor, Medical Microbiology, University Hospital Antwerp,
A more personalized approach identifying those patients who really need treatment is needed. Unfortunately, many of the currently available diagnostic methods are too slow. We have seen a technological revolution with the development of numerous
complex diagnostic assays. These systems can decrease the time required for detection of biomolecules, like proteins and nucleic acids, from a few hours to a few minutes and should greatly improve medical diagnostics. However most of these
technologies have not yet permeated clinical diagnostic laboratories. Is the paradigm shift likely to happen?
13:35 New European IVD Regulations – Update and Analysis
David E. Barton, Ph.D., Chief Scientist, National Centre for Medical Genetics, Ireland
The IVD Directive regulates the market for diagnostic tests within the EU. The current system is inflexible, unresponsive and does not do a good job of protecting patients. New regulations are being developed, which will radically alter the landscape
for IVDs in Europe. The regulations will have major implications for IVD manufacturers and for laboratory-developed tests. This presentation will bring the audience up to date on the latest developments.
14:05 The ESGMD Roadmap of Bringing New Technologies into the Clinic
Eric C.J. Claas, Ph.D., Associate Professor, Molecular Medical Microbiologist, Medical Microbiology, Leiden University Medical Center, The Netherlands
14:35 Solid Phase Multiplexed Electrochemical Quantitative Isothermal Amplification
Ciara K. O’Sullivan, Ph.D., ICREA Research Professor, Chemical Engineering,
Universitat Rovira i Virgili, Spain
An overview of different approaches for electrochemical quantitative isothermal amplification will be provided. The use of post-amplification detection vs. real-time detection will be compared using a model system of Francisella tularensis. The
optimised parameters applied to multiplexed detection of bioterrorist agents will then be outlined and future potential discussed.
15:05 Refreshment Break in the Exhibit Hall with Poster Viewing
15:45 Challenges of Integrating Functionalities in Diagnostic Devices for the Detection and Management of Infectious Diseases
Jesús M. Ruano-López, Ph.D., International Project Manager, Microsystems,
IK4-Ikerlan and CIC microGUNE, Spain
This talk will describe barriers and future opportunities of In Vitro Diagnostic (IVD) devices from the microfluidic innovation point of view in the field of infectious diseases. The microfluidic community is also facing opportunities: an incipient
technological maturity in microfluidic strategies for infectious diseases, the impact of the new IVD regulation on Laboratory Developed Tests (LDT), and the niche market left between liquid handling robotic systems and the point-of-care solutions.
This presentation will unfold these IVD hurdles and chances.
16:15 Evaluation of Novel Commercial Assays for Molecular Diagnosis of Infectious Disease
Peter Muir, Ph.D., FRCPath, Consultant Clinical Scientist, Specialist Virology Centre, Public Health
England, United Kingdom
Prior to adoption into clinical service, it is important to confirm that new commercial assays are fit for purpose. This presentation will describe some case studies in performance evaluation, which aims to demonstrate adequate analytical performance,
and clinical evaluation, which seeks to determine if a new assay can deliver a significant clinical or economic benefit when compared to existing practice.
16:45 Networking Reception in the Exhibit Hall with Poster Viewing
17:45 Close of Day
THURSDAY, 16 April
8:30 Breakfast Presentation (Sponsorship Opportunity Available) or Morning Coffee
9:00 Chairperson’s Remarks
Till T. Bachmann, Ph.D., University of Edinburgh, United Kingdom
9:05 Molecular Diagnostics of Antimicrobial Resistance at Point-of-Care
Till T. Bachmann, Ph.D., Reader, Personalised Medicine in Infectious Disease; Deputy
Head, Division of Infection and Pathway Medicine, College of Medicine and Veterinary Medicine, University of Edinburgh, United Kingdom
Antimicrobial resistance has become a threat of global dimension for healthcare systems and societies as it substantially diminishes our chances to fight bacterial infections with the current portfolio of drugs. Rapid diagnostics and especially
Point-of-Care Testing can help tackling this problem by giving healthcare professionals the needed information to choose the best therapeutic interventions where they most need them. Ultimately, the aim is to tackle antimicrobial resistance
by personalised approaches to administer the right treatments at the right time to the right patients as well as facilitating new drug developments using companion diagnostics for antibiotic therapies.
9:35 POC Molecular Testing in Resource-Limited Settings: The Landscape, The Opportunities, The Challenges
Maurine A. Murtagh, MBA, JD, CEO, International
Diagnostics Centre, London School of Hygiene & Tropical Medicine
Access to diagnostic testing in resource-limited settings is often limited, especially outside of urban centers. Centralized testing has been a limiting factor. As a result, there is great interest in implementing molecular tests that can
be used at or near the point of patient care, and there is a robust pipeline for such tests. However, implementation of POC testing platforms in resource-limited settings can be difficult. The challenges must be overcome in order to maximize
the potential of POC molecular testing.
Improving Infectious Disease Diagnostics: A Simple Biochip-Based Approach for Rapid, Targeted Multiplex Detection
Scott McKeown, Ph.D., Product Manager, Molecular, Randox Biosciences
Randox has developed multiplex microbiology panels for the detection of common infections from a single patient specimen. The technology has positive implications for the patient treatment pathway; appropriating antibiotic use and improving
use of resources within the healthcare system.
Current Requirements in the World of Point of Care Applications: A Short Overview
Spricigo, Ph.D., OEM Manager, QIAGEN Lake Constance
Healthcare professionals are looking for faster patient evaluation and efficient diagnosis. Rapid point-of-care tests are therefore becoming increasingly important as they provide precise quantitative results. The presentation will cover the
requirements for POC devices for lateral flow and isothermal amplification applications.
10:35 Coffee Break in the Exhibit Hall with Poster Viewing
11:15 Global Perspective on Clinical Utility and Cost-Effectiveness of New Technologies
Gyorgy Abel, M.D., Ph.D., Director, Molecular Diagnostics, Immunology & Clinical Chemistry,
Laboratory Medicine, Lahey Hospital & Medical Center, United States
The main drivers of point of care testing (POCT) are clinical demand and utility, and technological advances in molecular chemistry, microfabrication, miniaturization, microfluidics, nanochips, biosensors, lateral flow, paper-based devices,
and wireless communication. POCT in major hospitals is resource intensive and expensive, which may be offset by savings due to better outcomes and lower cost of overall care. Advancements in POCT are most spectacular in the fight against
infectious diseases, both in industrialized nations and resource-poor developing countries. The presentation highlights the major global technological and utilization trends in infectious disease POCT, and the related costs and clinical
11:45 Point-of-Care Microdevices for Virus Analysis
Siyang Zheng, Ph.D., Assistant Professor, Biomedical Engineering, The Pennsylvania State University,
Point-of-care microdevices can provide sensitive, accurate, rapid and low-cost virus analysis for a large population. As a useful platform, it must not only pursue single performance characteristics, but also excel at multiple performance
parameters. Throughout the past decades, tremendous progress has been made in point-of-care biomedical microdevices. The focus of the talk will be on lab-on-a-chip systems for viral infectious diseases.
12:15 Session Break
12:45 Luncheon Presentation (Sponsorship Opportunity Available) or Enjoy Lunch on Your Own
13:15 Session Break
14:15 Chairperson’s Remarks
Vanya Gant, Ph.D., FRCP, FRCPath, Divisional Clinical Director, Infection, Microbiology, UCLH NHS Foundation Trust, United Kingdom
14:20 The Diagnosis of Infectious Diseases by Whole Genome Next-Generation Sequencing
Marc Eloit, Ph.D., Chairman and CSO, PathoQuest; Head, Laboratory for Pathogen Discovery, Institut
The availability of next-generation sequencing (NGS) techniques is about to revolutionize diagnostics of infectious diseases by using a single test, based on microbe whole-genome NGS (WG-NGS) , which takes advantage of improvement in sample
preparation, availability of sequencers and optimized pipeline for taxonomic assignation. The presentation will show power and pitfalls of WG-NGS, and will illustrate its use in routine diagnosis.
14:50 Infectious Disease Applications of Next-Generation Sequencing
Vanya Gant, Ph.D., FRCP, FRCPath, Divisional Clinical Director, Infection, Microbiology, UCLH NHS
Foundation Trust, United Kingdom
There remains a significant gap between what is possible with NGS for detection of infectious diseases, and what is implemented at the front line of clinical service. This talk will explore some reasons why this might be, and offer some possible
15:20 Full Genome Virus Deep-Sequencing for Detection and Monitoring Transmission
Matthew Cotten, Ph.D., Senior Staff Scientist, Virus Genomics, Wellcome Trust Sanger Institute,
The presentation will cover topics such as: the methods of deep sequencing of RNA viruses, virus discovery methods and the utility of virus full genome data for diagnostics, for transmission studies and for monitoring zoonotic risks. Examples
will be provided from the work of our group on MERS coronavirus, rotavirus, norovirus and RSV transmission.
15:50 Designing Point of Care Instruments: Challenges and Proven Tools for Success
David James, Senior
Vice President, Diagnostics, Invetech
Developing market-leading instruments and consumables to meet the demanding requirements of Point of Care infectious disease markets requires specialist skills and experience. Product development stakeholders with competing priorities are
often challenged to find a method to agree on the "critical few" requirements that will provide the best product solutions. In this session you will learn about valuable tools and processes that are critical to first defining a winning
design and them delivering a robust and competitive final product in the shortest possible time to market.
16:20 Refreshment Break in the Exhibit Hall with Poster Viewing
17:00 Technical Features of MALDI-TOF Mass Spectrometry Systems for the Identification of Bacterial, Mycobacterial and Fungal Pathogens
Christine C. Ginocchio, Ph.D., MT (ASCP), Professor of Medicine,
Hofstra North Shore-LIJ School of Medicine; Vice President, Global Microbiology Affairs, bioMérieux, United States
Technical features and performance characteristics of the bioMérieux VITEK MS and Bruker MALDI BioTyper CA Systems for detection of bacteria, yeast and mycobacteria will be presented. Database development, methods for spectral analysis,
sample isolate preparation and results interpretation will be explained. Direct specimen testing from positive blood cultures will be reviewed. Impact of rapid results on laboratory workflow and clinical decision making will be discussed.
17:30 The RADICAL Trial: How the Iridica PCR/MS Device Performs in Critical Care
David Brealey, Ph.D., MRCP, FRCA, FFICM, Consultant in Intensive Care Medicine, University College London Hospitals NHS Foundation Trust, United Kingdom
The management of sepsis has changed little over the decades; multiple potential therapies have come and gone. Management still relies on rapid identification of the pathogen and initiation of appropriate antibiotics. Unfortunately current
techniques for bacterial detection are slow and frequently negative. The newer molecular techniques offer us an opportunity to change all this. The RADICAL study assessed a new PCR + Electrospray ionization mass spectrometry device
against standard hospital culture techniques in a critically ill population. We discuss the trial and whether the results are applicable.
18:00 Close of Conference