Cambridge Healthtech Institute’s Ninth Annual
Molecular Diagnostics for Infectious Disease: Novel Technologies & Advances
August 16-17, 2017 | Grand Hyatt Washington | Washington, DC
In the current diagnostics market, molecular diagnostics for infectious disease testing offers one of the brightest areas for growth and innovation. The infectious disease space is the most dominant and profitable sector and is expected to continue to grow. Novel molecular technologies continue to evolve and improve, significantly reducing the time it takes to diagnose infectious disease. The Molecular Diagnostics for Infectious Disease conference, now in its ninth year in Washington, DC, will showcase emerging technologies from both clinical and research laboratories. The development of point-of-care molecular assays for the detection of infectious diseases will be featured along with the advancement of molecular testing for respiratory diseases, and for emerging and re-emerging human viral diseases. Technologies, including NGS for detection of ID, will be highlighted as well as novel diagnostics to detect resistance mechanisms and to guide definitive therapeutic decisions that have the potential to significantly improve antibiotic use. Several talks will cover antibiotic stewardship.
Final Agenda
SC16: NGS for Infectious Disease Diagnostics
*Separate registration required
WEDNESDAY, AUGUST 16
10:30 am Registration
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
2:05 Chairperson’s Opening Remarks
Ephraim L. Tsalik, M.D., Ph.D., Assistant Professor, Medicine, Duke University School of Medicine
2:10 Implementation of Rapid Infectious Disease Molecular Diagnostics: The Role of Diagnostic and Antimicrobial Stewardship
Kevin Messacar, M.D., Assistant Professor of Pediatrics, University of Colorado/Children’s Hospital Colorado, Section of Infectious Diseases
New rapid molecular infectious disease diagnostics have potential to greatly impact clinical care when implemented using principles of diagnostic and antimicrobial stewardship. Diagnostic stewardship involves selection of appropriate technologies to implement in the clinical setting and directs testing towards appropriate patients. Antimicrobial stewardship ensures prompt, appropriate clinical response translating rapid results in the laboratory into improved outcomes at the bedside.
2:40 Host Response Transcriptomics at the Point-of-Care
Ephraim L. Tsalik, M.D., Ph.D., Assistant Professor, Medicine, Duke University School of Medicine
Rapid and reliable discrimination of bacterial, viral, and non-infectious illness can mitigate inappropriate antibiotic use and antimicrobial resistance. Host response transcriptomics provides a powerful, unbiased means of distinguishing disease states. However, there is no existing platform for transcriptomic analysis that is rapid, simple, and reliable. Supported by the ARLG and in partnership with BioFire Diagnostics, we are developing a rapid, sample-to-answer host response test that accurately distinguishes bacterial, viral, and non-infectious etiologies of acute respiratory illness.
3:10 Metagenomic NGS for Infectious Disease Diagnosis
Charles Chiu, M.D., Ph.D., Associate Professor, Laboratory Medicine and Medicine/Infectious Diseases, Director, UCSF-Abbott Viral Diagnostics and Discovery Center, Associate Director, UCSF Clinical Microbiology Laboratory, UCSF School of Medicine
Metagenomic next-generation sequencing (mNGS) allows the detection of the full spectrum of infectious microbes that cause disease (viruses, bacteria, fungi, and parasites) in a single assay. We have validated an mNGS assay to identify infectious causes of meningitis and encephalitis from cerebrospinal fluid in a clinically licensed (CLIA) laboratory, which is now available as a clinical reference test for acutely ill hospitalized patients. We will report the results of a multi-hospital, nationwide clinical study to evaluate the utility, performance, and cost-effectiveness of a Metagenomic next-generation sequencing (mNGS) assay relative to standard microbiological testing in diagnosis of these neurological infections. We will also describe new technologies and diagnostic approaches, including host response profiling to discriminate infectious versus non-infectious causes, antibiotic resistance determination, and nanopore sequencing, and how they can be incorporated into clinical diagnostic testing.
3:40SeqLL Technology Advantage and Diagnostics Potential
Tisha Elizabeth Jepson, Co-Founder and CEO, True Bearing Diagnostics, Inc.
3:55 Building a Comprehensive Syndromic Panel Menu Using High Multiplex qPCR Technologies
Helen Roberts, Ph.D., President, Seegene Technologies
Using proprietary DPO, TOCE and MuDT technologies, Seegene obtained a 510(k) clearance for its HSV types 1 & 2 assay and is focused on developing a comprehensive menu of high multiplex qPCR assay panels for clinical research and additional FDA submissions on Thermo's QS5 as well as POC instruments.
4:10 Refreshment Break in the Exhibit Hall with Poster Viewing
5:00 Universal Pathogen Detection by Next-Generation Sequencing in Routine Diagnostic Practice
Robert Schlaberg, M.D., MPH, Medical Director, ARUP Laboratories, Assistant Professor of Pathology, The University of Utah
Routine tests often fail to provide etiologic diagnoses in common diseases like pneumonia and encephalitis/meningitis. Early etiologic diagnosis is critical for effective treatment and reduces morbidity and mortality. NGS strategies can provide universal pathogen detection and improved diagnostic yield. However, complex workflows and long turnaround times have hindered adoption. We have developed and validated tools for rapid NGS-based universal pathogen detection providing results within 48 hours.
5:30 Pathogen Detection Standards for NGS and Metagenomics
Jason Kralj, Ph.D., Staff Scientist, Complex Microbial Systems Group, Biosystems and Biomaterials Division, Material Measurements Laboratory, NIST
We will describe development of the mixed pathogen DNA reference material for use in NGS-based metagenomics applications, and explore its role in evaluating the sensitivity and specificity of pathogen detection within analysis workflows.
5:50 Validation of an Average Nucleotide Identity Assay for Bacterial Identification in a Public Health Laboratory
Maryann Turnsek, Microbiologist, National Enteric Reference and Outbreak (NERO) Team, NCEZID/DFWED/EDLB, Centers for Disease Control and Prevention (CDC)
Laboratory standards for NGS methods have not yet been established for clinical and public health laboratories. Compliance with existing regulatory and quality standards can be especially challenging for NGS assay validation because the traditional definitions for performance characteristics do not readily translate. This presentation will detail the validation plan of a NGS-based assay using the Average Nucleotide Identity (ANI) method for bacterial identification within a public health laboratory regulated under the Clinical Laboratory Improvement Amendments (CLIA) of 1988, and address the most recent developments on the implementation of best practices and quality guidelines for NGS methodologies.
6:10 Metagenomics for Rapid Pathogen Detection and Characterization of the Microbiome in Health and Disease
Rita Colwell, Ph.D., Distinguished Professor, University of Maryland at College Park and Johns Hopkins University Bloomberg School of Public Health
Next-gen sequencing, combined with high-resolution metagenomic analysis, offers a new powerful method for diagnosis of infectious diseases. We applied this in several clinical studies, including a retrospective case control study comprising samples of known and unknown etiology, as well as samples from healthy individuals. The results are promising and demonstrate that microbiome analysis could potentially differentiate healthy, diseased, and asymptomatic carriers, including individuals in the early stages of infection and disease.
6:30 Close of Day
6:30 Dinner Short Course Registration
6:45 – 9:15 pm Recommended Dinner Short Course(s)*
SC15: Use of CLIA-Waived Point-of-Care and Rapid Diagnostic Tests in Community Pharmacies
SC16: NGS for Infectious Disease Diagnostics
*Separate registration required
THURSDAY, AUGUST 17
7:30 am Problem-Solving Breakout Discussions with Continental Breakfast
Point-of-Care Dx for ID
Moderator: Nathan Ledeboer, Ph.D., Associate Professor of Pathology and Medical Director, Medical College of Wisconsin
- How to evaluate the impact of rapid diagnostic tests on clinical decision making
- What is the impact and outcome benefit seen today of rapid diagnostic tests on clinical decision making?
- What is the benefit of POC testing to antimicrobial stewardship?
Rapid Diagnostic Testing and Antimicrobial Stewardship
Moderator: Erin McElvania TeKippe, Ph.D., D(ABMM), Assistant Professor of Pathology and Pediatrics, University of Texas Southwestern Medical Center, Director of Clinical Microbiology, Children’s Health
- How much impact is rapid testing having on microbial stewardship and clinical outcomes?
- What is the clinical impact of real-time antimicrobial stewardship?
- What are the challenges still faced in antimicrobial stewardship?
8:25 Chairperson’s Opening Remarks
Nathan Ledeboer, Ph.D., Associate Professor of Pathology and Medical Director, Medical College of Wisconsin
8:30 Molecular Detection of C. difficile - Clinical Significance and Utility
Ferric C. Fang, M.D., Professor of Laboratory Medicine, Microbiology and Medicine, University of Washington School of Medicine
The development of nucleic acid amplification tests (NAATs) for Clostridium difficile has improved analytical sensitivity but created new concerns about the potential for over-diagnosis. Dr. Fang will review current controversies in C. difficile diagnosis, consider various proposals for testing algorithms, and suggest how NAATs can be best utilized for patient care and infection control.
9:00 Diagnostic Testing for C. difficile Infection (CDI): Why Toxin Tests Still Matter
Christopher R. Polage, M.D., MAS, Associate Professor of Pathology and Infectious Diseases, University of California, Davis School of Medicine
Current nucleic acid amplification tests (NAATs) are sensitive for Clostridium difficile DNA but unable to distinguish colonization from infection. Dr. Polage will review key studies showing the value of toxin tests to minimize over-diagnosis and unnecessary treatment by identifying patients with a low likelihood of infection who need more evaluation before treatment. New European diagnostic guidelines will also be discussed.
9:30 Development of Cell-Based Full-Process Control Samples That Mimic Patient Samples for Molecular Diagnostic Testing
Matthew Sobansky, Ph.D., Research & Development, Senior Scientist, Molecular Technology, Streck
The increased clinical use of molecular tests for disease identification has required development of complete and improved process controls for use in these diagnostic tests. This talk will describe the use of proprietary stabilization chemistry to provide improved cellular controls within a biological matrix. These controls mimic patient samples and are used to monitor the accuracy and precision of the entire analytical process for a molecular diagnostic system resulting in increased compliance with regulatory requirements.
10:00 Coffee Break in the Exhibit Hall with Poster Viewing
11:00 The Application of Rapid Molecular Diagnostic Testing to Improve Patient Care in Acute Care Settings
Larissa S. May, M.D., Associate Professor, Department of Emergency Medicine, University of California, Davis
This talk will focus on the opportunities as well as challenges of implementing rapid molecular diagnostic tests in acute care settings. Application of potential diagnostic testing strategies will be discussed through a review of published and ongoing studies as well as through case-based format. Participants will understand the importance of appropriate integration into the clinical environment including workflow assessment, alignment with clinical operations, and antimicrobial stewardship and patient safety goals. The need for additional studies focused on the impact of diagnostic testing on patient care outcomes, and cost effectiveness will be highlighted.
11:30 Striving for Better Patient Outcomes: The Role of Rapid Diagnostic Testing and Antimicrobial Stewardship
Erin McElvania TeKippe, Ph.D., D(ABMM), Assistant Professor of Pathology and Pediatrics, University of Texas Southwestern Medical Center, Director of Clinical Microbiology, Children’s Health
There has been an explosion of rapid diagnostic testing introduced into the clinical microbiology laboratory, but data on its ability to improve patient outcomes has been lacking. This talk will discuss how rapid diagnostic testing in conjunction with real-time antimicrobial stewardship can maximize the impact of these tests to affect care and improve patient outcomes.
EMERGING TECHNOLOGIES
12:00 pm Identification of the Bacteria Direct from Specimen by MALDI-TOF-MS of Microbial Membrane Glycolipids
Robert K Ernst, Ph.D., Professor and Vice Chair, Department of Microbial Pathogenesis, University of Maryland – Baltimore
Pathogen identification from single colonies by MALDI-TOF-MS analysis of high abundance proteins is gaining popularity in clinical laboratories. We present a novel and complementary approach that utilizes essential microbial glycolipids for identification of individual Gram-positive and -negative bacterial species alone or in mixtures using a single optimized protocol that allows identification direct from specimens such as urine and blood.
12:30 A Novel Host Protein-Based Assay and POC Platform for Rapidly Distinguishing between Bacterial and Viral Infections
Eran Eden, Ph.D., Co-founder and CEO, MeMed
We have developed a novel assay integrating host protein measurements (TRAIL, IP-10, CRP) as an aid to differentiate bacterial from viral infection; its diagnostic performance was demonstrated in 3 independent clinical studies (n = 2376). The assay is being mounted on a user-friendly platform that provides results within 15 minutes.
12:45 Adventures in Zika Diagnostics
Benjamin Pinsky, M.D., Ph.D., Assistant Professor, Departments of Pathology and Medicine, Stanford University School of Medicine; Medical Director, Clinical Virology Laboratory, Stanford Health Care and Stanford Children’s Health
Zika virus (ZIKV) is an Aedes mosquito-borne flavivirus that emerged in Brazil in 2015 and then rapidly spread throughout the tropical and subtropical Americas. Based on clinical criteria alone, ZIKV cannot be reliably distinguished from infections with other pathogens that cause an undifferentiated systemic febrile illness, including infections with two common arboviruses, dengue virus and chikungunya virus. This talk details molecular methods that are available to diagnose ZIKV infection.
1:00 Luncheon Presentation: Mobilizing Genomics & Diagnostics for Pathogen Detection & Biosurveillance
Jonathan Jacobs, Ph.D., Senior Advisor, Global Health and Surveillance, MRIGlobal
1:30 Session Break
2:00 Chairperson’s Remarks
Elena Grigorenko, Vice President, Research and Development, Diatherix, Eurofins Clinical Diagnostics, LLC
2:05 One Size Does Not Fit All – Individualized Approaches Are Needed to Optimize Rapid Diagnostic Test Impact and Integration into Stewardship Programs
Ritu Banerjee, M.D., Ph.D., Associate Professor, Pediatric Infectious Diseases, Vanderbilt University Medical Center, Director of Pediatric Antimicrobial Stewardship, Monroe Carell Jr. Children’s Hospital at Vanderbilt
The clinical impact of rapid diagnostic tests for infectious diseases is maximized when testing is integrated with antimicrobial stewardship interventions. The ideal approach to diagnostic testing and implementation strategies will vary between healthcare institutions, and will be based on local microbiology, prevalence of resistance mechanisms, laboratory workflow, antimicrobial prescribing patterns, and antimicrobial stewardship activities.
2:35 The Challenges of Rapid Diagnostics for Infectious Diseases, Is Anyone Paying Attention?
Nathan Ledeboer, Ph.D., Associate Professor of Pathology and Medical Director, Medical College of Wisconsin
Over the past few years, several point-of-care and near point-of-care molecular assays have been developed for detection of influenza and S. pyogenes. These new assays are CLIA-waived and offer the ability to perform testing during a physician office visit. However, few studies have evaluated the impact of rapid diagnostic tests on clinical decision-making. This session will evaluate the antimicrobial stewardship and outcome benefits of POC testing for infectious agents.
3:05 Using CLIA-Waived POCT for Outpatient Antimicrobial Stewardship
Michael Klepser, Pharm.D., FCCP, Professor, Pharmacy Practice, Ferris State University College of Pharmacy
The White House has published a national action plan to combat antibiotic-resistant bacteria. Central to the plan is the use of POC diagnostics. This talk will review the goal of the action plan and review data regarding the use of CLIA-waived POCT to improve antibiotic use in the outpatient setting. Areas of future needs will be discussed.
3:35 The Role of Molecular Diagnostics in Antibiotics Stewardships Programs and Challenges Associated with Implementation of Genotypic Assays for Detection of Multi-Drug Resistant Organisms
Elena Grigorenko, Vice President, Research and Development, Diatherix, Eurofins Clinical Diagnostics, LLC
The increasing threat of antibiotic resistance is of worldwide public health concern. Empirical therapy for treatment of infectious diseases has helped create bacterial strains with multiple antibiotic resistance mechanisms. Rapid molecular testing can offer a change in paradigm for susceptibility testing and can have a significant impact on patient care. The direct testing for genes associated with resistance to 4 major classes of antibiotics with a high-throughput PCR platform is a powerful screening tool that can be utilized in clinical settings to lower healthcare costs, reduce unnecessary antibiotic use, and improve patient care.
4:05 Close of Conference
4:30 Symposia & Short Course Registration
5:00 – 7:30 pm Dinner Short Courses
Recommended Dinner Short Course(s)*
SC20: Bioinformatics Bootcamp: NGS for Forensic Scientists
*Separate registration required
RECOMMENDED CONFERENCE SYMPOSIUM:
Advances in Microbiome Diagnostics
Separate registration required