Recent advances in technology have rapidly changed the landscape of infectious disease diagnostics. Novel technologies (and new uses for already standard technologies!) such as next-generation sequencing (NGS) and mass spectrometry are changing the way that researchers perform rapid diagnostics and detect antimicrobial resistance. The Fourth Annual Advanced Diagnostics for Infectious Disease will bring together leaders in the field to showcase the latest in technologies for diagnosing, monitoring, and managing infectious disease outbreaks and emerging pathogens. Special consideration will be given to emerging pathogens and the potential role of the microbiome in infectious disease diagnostics.
Final Agenda
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Recommended Short Course*
SC1: Technologies, Applications and Commercialization of Point-of-Care Diagnostics [View Detailed Agenda]
Holger Becker, PhD, Founder & CSO, microfluidic ChipShop GmbH, Germany
This short course will provide an overview on the technological aspects of POC system developments. It will introduce current technologies such as microfluidics, sensors, paper- and smartphone-based approaches and discuss their trends and limitations. The course will discuss a variety of POC systems in different stages of their development, from early stage to established diagnostic systems in the clinical routine. Market aspects of POC systems as well as practical examples of commercialization for molecular diagnostic, immunological and clinical tests will be presented.
*Separate Registration required.
TueSDAY, 22 MAY
08:00 Registration and Morning Coffee
09:00 Chairperson’s Remarks
François Jean, PhD, Associate Professor, Department of Microbiology and Immunology, University of British Columbia, Team Leader, NCE IC-IMPACTS Grant in Next Generation Molecular Diagnostics for Emerging Viral Diseases, and CIHR Grant in Anti-Flavivirus Drug Discovery, Canada
09:05 KEYNOTE PRESENTATION: An Overview on the Emergence of Arbovirus Epidemics in the World and Their Consequences
Pedro Fernando da Costa Vasconcelos, MD, PhD, Medical Virologist, Director, Evandro Chagas Institute, Ministry of Health, Brazil
Zika virus (ZIKV) can be transmitted to humans by different mechanisms. Since the traditional Aedes aegypti mosquito infected bite through congenital and sexual routes has been used by ZIKV. Many different studies have demonstrated that ZIKV is predominantly neurothropic, and infection can result in encephalitis, which is especially severe among fetus and neonates whose mothers were infected during pregnancy. The fetus infection occur through placenta cells and ZIKV reaches the central nervous system probably through the blood and depending of the time of infection is before the formation of or break the blood brain barrier. On the other side, other studies showed that ZIKV is associated with severe disease for people with immunologic disorders as well. For neonates and immunodeficient/immunosuppressive adult’s patients, an important involvement of innate and adaptive immune responses is critical in the host response and pathogenesis of disease caused by ZIKV. On the other hand, the development of a live attenuated ZIKV vaccine was aimed to prevent the microcephaly and other congenital defects associated with ZIKV infection during pregnancy. In this presentation, the participation of immune cells and cytokine/chemokine expression and changes in target organs and the approach used for the development of a live-attenuated ZIKV vaccine will be addressed and discussed taking into account the pivotal role of immune system in the pathogenesis of ZIKV infection, disease presentation and outcome.
10:05 Pushing the Frontiers of Clinical Proteomics: Absolute Quantification of Circulating Infectious Virus Particles by MRM-MS
François Jean, PhD, Associate Professor, Department of Microbiology and Immunology, University of British Columbia, Team Leader, NCE IC-IMPACTS Grant in Next Generation Molecular Diagnostics for Emerging Viral Diseases, and CIHR Grant in Anti-Flavivirus Drug Discovery, Canada
The four serotypes of dengue virus (DENV-1/2/3/4) impose a significant global health burden, with 3.9 billion people living in endemic areas and 390 million cases annually. An important risk factor for developing life-threatening severe dengue is a prior infection with a heterologous DENV serotype, which includes the maturation state of the DENV particles since it modulates the functional outcome of interactions with pre-existing anti-DENV antibodies. Therefore, accurate serotype-specific diagnoses of all 4 DENVs and their maturation states are important. Here we report novel multiplexed multiple reaction monitoring-mass spectrometry (MRM-MS) assays, i.e., N-terminal acetyl (NTAc) labeling MRM assays, for determining the absolute numbers of DENV pre-membrane (prM) and cleaved M-anchored surface glycoproteins on circulating virions. Our multiplexed NTAc-MRM assays are the first DENV-targeted MRM-MS assays for detecting and quantitating the degree of maturity (“infectiveness”) of all four circulating DENV particles in biological samples. (Funded by NCE IC-IMPACTS and CIHR)
10:35 Coffee Break in the Exhibit Hall with Poster Viewing
11:15 Highly Pathogenic Polyomavirus Strains and Viral MicroRNA Expression
Eeva Auvinen, PhD, Senior Laboratory Supervisor, Department of Virology and Immunology, Helsinki University Hospital Laboratory, Finland
Rearrangements in the JC polyomavirus genome are required for development of PML, a fatal brain disease. We have shown by massive parallel sequencing of complete viral genomes that several rearranged JC strains may be found in the brain of PML patients. However, in BK nephropathy and in the rare JC nephropathy, viral strains harbor few rearrangements in the regulatory region. Viral microRNAs are frequently expressed and have biomarker potential. Viral strain variations may be associated with altered viral microRNA expression.
11:45 Matrix-Assisted Laser Desorption/Ionization Time-of-Flight (MALDI-TOF) Mass Spectrometry Applied to Virus Identification
Adriana Calderaro, MD, PhD, Associate Professor, Clinical Microbiology, Unit of Microbiology and Virology, Department of Medicine and Surgery, University Hospital of Parma, Italy
The innovative application of MALDI-TOF mass spectrometry to virology, recently performed in our laboratory for the identification and/or serotyping of different viruses infecting humans including polioviruses, respiratory viruses, adenoviruses was described. Moreover, a preliminary application to HBV/HCV positive serum samples will be described.
12:15 Recent Advances in qPCR Reagent Lyophilization
Junko Stevens, Senior Director, Research & Development, Genetic Sciences Division, Thermo Fisher Scientific
The use of qPCR for detecting infectious diseases has become routine practice in recent years due to the simple workflow, sensitivity and cost. Molecular Diagnostics companies are seeking solutions to overcome thermo labile properties of standard qPCR reagents. We have developed various lyophilization-ready (lyo-ready) polymerase and reverse transcriptase formulation. In addition to lyo-ready components, we will showcase lyo-ready 1 step RT-PCR Master Mix and lyophilized Multiplex PCR assays for infectious disease detection.
12:45 Enjoy Lunch on Your Own
14:15 Chairperson’s Remarks
Matthew Cotten, PhD, Senior Staff Scientist, Viroscience, Erasmus Medical Center, the Netherlands
14:20 Challenges of Using Next-Generation Sequencing for Diagnostic Applications
Matthew Cotten, PhD, Senior Staff Scientist, Viroscience, Erasmus Medical Center, the Netherlands
Advances in next generation sequencing (NGS) allow investigators to quickly generate detailed sequence data from a variety of clinical samples. These methods can provide viral genomic sequences from clinical samples and these sequence data are useful for tracking viruses through the community, for monitoring antigenic changes in the viruses and for detecting novel viral agents. The typical concentration of viral nucleic acid relative to total nucleic is often low in clinical samples. Classification algorithms are needed that can rapidly detect and classify low frequency virus sequences amidst a high sequence background. The new technologies are also sensitive to contamination and new algorithms to detect and set thresholds for contamination are being developed. I will discuss some the challenges faced as we apply NGS to viral diagnostics and describe how we are meeting these challenges with examples from our work on Ebola virus, MERS coronavirus, norovirus and respiratory syncytial virus.
14:50 Selected Poster Presentation: Cross Platform Comparison of PCR Assay for Detection of H. pylori and Mutations
Erin Beckman, Research Assiciate, Meridian Bioscience, United States
Clarithomycin is a first-line drug of choice for treatment in Helicobacter pylori infection; as such there is increasing importance for detecting resistance strains. In addition, testing for these resistant strains with a biopsy specimen requires an endoscopic procedure that carries its own risks. This talk will review a study that aimed to verify that the H. pylori genotyping assay from stool can be app lied to several real-time PCR platforms. Results show that the limit of detection and stool specimen performance is comparable across platforms when the appropriate parameters are applied. All platforms are capable of distinguishing genotype by the melt curve function.
15:20 New Opportunities in the Control of Infectious Diseases in an Era of European Clinical Microbiology Laboratories Consolidation
Olivier Vandenberg, MD, PhD, Professor, Microbiology, Laboratory Medicine, Laboratoire Hospitalier Universitaire de Bruxelles, Belgium
European clinical microbiology laboratories (CMLs) are currently undergoing a process of consolidation involving a shift towards laboratory amalgamation. The centralization of diagnostic services over a large geographical region gave rise to the concept of regional-scale “microbiology laboratories network.” In this lecture, we describe the range of opportunities that the changing landscape of CMLs in Europe can contribute towards improving the quality of patient care but also the early detection and enhanced surveillance of public health threats caused by infectious diseases.
15:50 PANEL DISCUSSION: Future Directions and Technologies for Virus Identification
Moderator: François Jean, PhD, Associate Professor, Department of Microbiology and Immunology, University of British Columbia, Team Leader, NCE IC-IMPACTS Grant in Next Generation Molecular Diagnostics for Emerging Viral Diseases, and CIHR Grant in Anti-Flavivirus Drug Discovery
Panelists: Adriana Calderaro, MD, PhD, Associate Professor, Clinical Microbiology, Unit of Microbiology and Virology, Clinical and Experimental Medicine, University Hospital of Parma, Italy
Eeva Auvinen, PhD, Senior Laboratory Supervisor, Department of Virology and Immunology, Helsinki University Hospital Laboratory, Finland
- Host-derived biomarkers to diagnose and monitor infectious disease
- Emerging techniques and technologies
- Advancements in mass spectrometry-based detection
- Rapid detection strategies
16:20 Refreshment Break in the Exhibit Hall with Poster Viewing
17:00 Breakout Discussions
Point-of-Care Testing and Issues with the Microbiome
Moderator: Norman Moore, Ph.D., Director of Scientific Affairs, Abbott Rapid Diagnostics
- Factors influencing doctors to prescribe antibiotics with or without diagnostic results
- Factors influencing patients to demand antibiotics
- Overall understanding of the benefits and disadvantages to the microbiome with current antibiotic/antibacterial prescribing habits
Rapid Testing
Moderator: Oliver Liesenfeld, MD, CMO, Inflammatix, United States
- Rapid molecular tests vs traditional diagnostic methods
- Benefits and disadvantages of rapid testing
- Pathogen detection vs. host response signatures
- Choosing the right method or test
- Barriers to clinical implementation
18:00 Welcome Reception in the Exhibit Hall with Poster Viewing
19:00 Close of Day
Day 1 | Day 2 | Download Brochure | Speaker Bios
wedneSDAY, 23 MAY
08:00 Registration and Morning Coffee
09:00 Chairperson’s Remarks
Till T. Bachmann, PhD, Reader, Personalised Medicine in Infectious Disease; Deputy Head, Division of Infection and Pathway Medicine, dinburgh Medical School, College of Medicine and Veterinary Medicine, University of Edinburgh, United Kingdom
09:05 Towards the Right Target Product Profiles for Rapid Diagnostics to Reduce Antimicrobial Resistance
Till T. Bachmann, PhD, Reader, Personalised Medicine in Infectious Disease; Deputy Head, Division of Infection and Pathway Medicine, Edinburgh Medical School, College of Medicine and Veterinary Medicine, University of Edinburgh, United Kingdom
Rapid diagnostics are urgently required to tackle the soaring problem of antimicrobial resistance. A wide range of technological approaches to address this need has been researched and subsequently, commercial tests have been developed. Unfortunately, a wide adoption of rapid tests to guide antimicrobial therapy is still lacking and the issue of AMR is escalating. The Transnational Working Group AMR Rapid Diagnostic Tests (AMR RDT) of the Joint Programming Initiative on Antimicrobial Resistance (JPIAMR) specifically reviewed the barriers for development and adoption of rapid diagnostics. The working group identified the absence of suitable and accessible Target Product Profile as a major barrier and proposed solutions how to overcome this which will be discussed in the presentation.
09:35 HostDx Sepsis: Diagnosing Presence, Type, and Severity of Acute Infections through Host Response
Oliver Liesenfeld, MD, CMO, Inflammatix, United States
Diagnostics for acute infections and sepsis typically focus on ‘finding the bug’, but most patients with infections never have pathogens in their bloodstream. HostDx Sepsis uses robust patterns of mRNA biomarkers from whole blood to determine the presence, type, and severity of any acute infection in an inpatient setting. We will present interim results from new prospective trials, including comparisons with known biomarkers such as procalcitonin. HostDx Sepsis is being translated into a < 60-minute turnaround point-of-need test.
10:05 Beyond Antibiotic Resistance: Consequences of Overtreating Infectious Disease
Norman Moore, PhD, Director, Scientific Affairs, Abbott, United States
Antibiotics not only kill pathogens, but disrupt a person’s microbiome. Changes in the microbiome have now been linked to obesity, mood disorders, autoimmune diseases, and a host of other issues. This lecture will go through the latest data on diseases associated with imbalances in the human microbiome.
10:35 Recent Advances in Manufacturing Technologies of Microarrays for Diagnostic of Infectious Diseases
Wilfried Weigel, PhD, Vice President, Research & Development, Scienion, Germany
Planar microarrays are cost effective tools for the multiplexed detection of pathogens in infectious diseases. Key steps in development and high throughput production of these microarrays, are the printing and immobilization of probes on the different supports materials, such as microtiter plates, lateral flow strips, slides or biosensors.
10:50 Sponsored Presentation (Opportunity Available)
11:05 Coffee Break in the Exhibit Hall with Poster Viewing
11:35 Plenary Introduction
John Carrano, CEO, Paratus Diagnostics, LLC, United States
11:45-12:15 The New EU IVD Regulation – What Will It Mean for Your Lab?
David E. Barton, PhD, Chief Molecular Geneticist, National Centre for Medical Genetics, Our Lady’s Hospital for Sick Children, Ireland
In May 2017, Europe passed a new Regulation on in vitro Diagnostic Devices (IVDs). The regulation sets up a framework for controlling the market for diagnostic tests within the EU, setting out standards for the design and manufacture of in-vitro diagnostic devices (IVDs) and providing mechanisms for the oversight of these standards. This presentation will outline the content of the new regulations, with a particular focus on molecular diagnostics, and highlight the new requirements for clinical laboratories.
12:15-12:25 Introduction: Medicinal Product Regulators Point of View: Scientific-Regulatory Aspects of Companion Diagnostics and Challenges for Validation during Clinical Co-Development (Quality-Related Aspects)
Jörg Engelbergs, PhD, Scientific Expert and Assessor Biomedicines (Quality, Non-Clinic & Personalized Medicine), Section Mono- and Polyclonal Antibodies, Paul-Ehrlich-Institut, Federal Institute for Vaccines and Biomedicines, Germany
In Europe, the legislation for marketing of medicinal products (MP) and IVDs including predictive biomarker-based assays (Companion Diagnostics, CDx) are not directly linked which is challenging for co-development. The new IVDD involves MP regulators in the CDx review process for CE marking. This presentation will outline from the perspective of MP regulators the scientific-regulatory challenges for technical validation of CDx. Differences between exploratory assays and assays used for patient stratification, as well as aspects for complex assays will be addressed.
12:25-13:30 PANEL DISCUSSION: Changing Landscape for IVDs in the EU
Moderator:
Charlotte Ryckman, Covington & Burling LLP, Belgium
Panelists:
David E. Barton, PhD, Chief Molecular Geneticist, National Centre for Medical Genetics, Our Lady’s Hospital for Sick Children, Ireland
Jörg Engelbergs, PhD, Section Mono- and Polyclonal Antibodies, Scientific Expert Biomedicines, Quality, Non-Clinic & Personalized Medicine (Biomarker/CDx), Paul-Ehrlich-Institut, Federal Institute for Vaccines and Biomedicines, Germany
Maria Judite Neves, Health Products Director, Health Products Directorate, INFARMED – National Authority of Medicines and Health Products, Portugal
Sue Spencer, Global Service Director, Regulatory, UL, United Kingdom
Andreas F. Stange, PhD, Vice President, MHS Global IVD, TÜV SÜD, Germany
Doris-Ann Williams, MBE, Chief Executive, British In Vitro Diagnostics Association (BIVDA), United Kingdom
- Practical impact of the new IVD Regulation
- Regulatory aspects of companion diagnostics
- Challenges for validation
- Role of IVDs in the market
13:30 Close of Advanced Diagnostics for Infectious Disease
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