Cambridge Healthtech Institute’s Tenth Annual
Molecular Diagnostics for Infectious Disease
Novel Technologies and Advances to Improve Clinical Outcomes
August 22-23, 2018 | 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. Novel technologies continue to emerge, significantly reducing the time it takes to diagnose infectious diseases. The tenth annual Molecular Diagnostics for Infectious Disease conference will showcase emerging technologies from both the clinical and research perspectives. The advancement of molecular testing for emerging and re-emerging human pathogens will be featured. Novel technologies, including NGS and multiplex molecular panels for identification of pathogens, will be highlighted as well as point-of-care and rapid testing methods to guide definitive therapeutic decisions that have the potential to significantly improve clinical outcomes. Special consideration will be given to antimicrobial resistance, antibiotic stewardship, and sepsis.
Final Agenda
SC6: Rapid Diagnostics for Antimicrobial Stewardship
Jennifer Dien Bard, PhD, D(ABMM), Director, Microbiology and Virology, Children’s Hospital Los Angeles; Associate Professor, Pathology and Laboratory Medicine, Keck School of Medicine, University of Southern California
April Abbott, PhD, D(ABMM), Director, Microbiology, Deaconess Health System
Amanda Harrington, PhD, Associate Professor, Pathology; Medical Director, Microbiology, Loyola University Medical Center
*Separate registration required
WEDNESDAY, AUGUST 22
7:45 am Registration and Morning Coffee (Independence Foyer)
8:25 Chairperson’s Opening Remarks
Charles Chiu, MD, PhD, 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
8:30 Diagnostic Stewardship: When Less Is More
Kevin Messacar, MD, Assistant Professor, Pediatrics, University of Colorado/Children’s Hospital Colorado, Section of Infectious Diseases
Emerging diagnostic technologies for infectious diseases allow more rapid, accurate identification of organisms, but can create confusion and wasted resources if utilized in low-pre-test probability situations. Clinical impact and cost-effectiveness are ranked highly by health care facilities when considering uptake of new diagnostic technologies. This session will outline key strategies of diagnostic stewardship to target testing using new diagnostics towards high-yield patient populations, thereby maximizing clinical impact and cost-effectiveness.
9:00 Diagnostic Stewardship for Clostridium difficile Testing
Christopher Polage, MD, MAS, Medical Director, Duke University Health Systems Clinical Microbiology Laboratory; Associate Processor, Duke University Medical Center
The inability of Clostridium difficile diagnostic tests to distinguish between infection and colonization in patients makes proper patient selection before testing of paramount importance. Diagnostic stewardship is a pre-analytic intervention to minimize testing of patients with low likelihood of C. difficile infection and reduce overdiagnosis caused by detection of C. difficile DNA (or toxins) in patients without clinically significant C. difficile disease. The rationale and approaches to diagnostic stewardship for C. difficile testing will be discussed.
9:30 Implementing Outpatient Antimicrobial Stewardship in a Community Pharmacy
Michael Klepser, PharmD, FCCP, Professor, Pharmacy Practice, Ferris State University College of Pharmacy
Approximately 60%-80% of antibiotic use occurs in the outpatient setting, and it has been estimated that more than half of this use is inappropriate. The government has set a goal of reducing inappropriate outpatient antibiotic use by 50%. Several investigators have described development of physician /pharmacist collaborative care models that incorporate the use of CLIA-waived point-of-care test to identify patients with various infections. Data from these models reveal reduction in the inappropriate use of antibiotics by >50% over historical controls for conditions such as acute pharyngitis and influenza.
10:00 Performance and Genotyping Results from the BD Onclarity™ HPV Assay
Jeff Andrews, MD, FRCSC, Worldwide Medical Director, Women’s Health Center, BD Life Sciences
The assay is FDA-approved for ASC-US-reflex, co-testing with cytology, and primary HPV paradigms. Results from the USA clinical trial of 33,858 women will be presented. Performance of the BD Viper™ LT system will be described. Assay throughput can be extended using the next generation high throughput system, BD COR™ system.
10:15 Multiplex Detection of Acute & Chronic Respiratory Infections Using the Biochip Array Technology
Claire Huguet, PhD, Head, Biomarker Services, Randox Bioscience
10:30 Coffee Break in the Exhibit Hall with Poster Viewing (Independence Ballroom)
11:15 Real-Time Whole-Genome Sequencing of MDROs for Hospital Antimicrobial Stewardship and Infection Control
Guiqing (Hank) Wang, MD, PhD, Chief of Labs, Pathology and Clinical Laboratories, Westchester Medical Center & New York Medical College
Real-time monitoring of multidrug-resistant organisms (MDROs) using whole-genome sequencing (WGS) provides unprecedented resolution, dynamic population genetics and precise actionable results against resistant organisms in a healthcare setting. We started real-time WGS analysis of ESKAPE organisms at a tertiary medical center in November 2016. Integrated bacterial genomics from more than 2,000 unbiased MDRO strains with other laboratory and clinical data have been used successfully to guide hospital antimicrobial stewardship program and precision infection control practice.
11:45 Molecular Approaches to Diagnosing Meningitis and Encephalitis
Jennifer Dien Bard, PhD, D(ABMM), Director, Microbiology and Virology, Children’s Hospital Los Angeles; Associate Professor, Pathology and Laboratory Medicine, Keck School of Medicine, University of Southern California
Meningitis and encephalitis are associated with significant morbidity and mortality. Traditional approaches may be suboptimal to recover certain pathogens. Emerging molecular technologies have shifted the diagnostic paradigm. This session will provide an overview of the current approaches to the laboratory diagnosis of meningitis/encephalitis, with a focus on molecular technologies. The clinical utility and potential impact on patient management and outcome will also be discussed.
12:15 pm Clinical Outcome Benefits of Rapid Diagnosis of Meningitis and Encephalitis
Nathan Ledeboer, PhD, Associate Professor of Pathology and Medical Director, Medical College of Wisconsin
Syndromic panels were first FDA-approved for detection of respiratory pathogens in 2008. Since then, other panels have been approved by the FDA and most recently the FilmArray Meningitis/Encephalitis panel (BioFire, Salt Lake City, UT) has become available. Several studies have reported both false-positive and false-negative results with this test and all agree the cost is significant. Little has been published on the outcome benefits this technology offers in management of patient admission and antimicrobials. This session will explore the outcome benefits of this technology when coupled with active antimicrobial stewardship.
12:45 Luncheon Presentation: Analytical and Clinical Validation of a Microbial Cell-Free DNA Assay for Pathogen Detection
Tim Blauwkamp, PhD, CSO, Karius
Microbial cell-free DNA sequencing offers great potential to non-invasively identify a wide range of pathogens, but a number of challenges associated with such comprehensive testing must be addressed. We share our experience developing and validating a next-generation sequencing test that identifies and quantifies microbial cfDNA in plasma from 1,250 clinically relevant pathogens. .
1:15 Session Break
1:45 Chairperson’s Remarks
Christopher Polage, MD, MAS, Medical Director, Duke University Health Systems Clinical Microbiology Laboratory; Associate Processor, Duke University Medical Center
1:50 Harnessing the Host Molecular Response to Health and Disease
Ephraim L. Tsalik, MD, MHS, PhD, Associate Professor, Medicine, Duke University School of Medicine; Founder, Predigen, Inc.
Rapid and reliable identification of infection and pathogen class can mitigate inappropriate antibiotic use and antimicrobial resistance. Measuring the transcriptional and proteomic response of the host provides a powerful, unbiased means of distinguishing disease states. However, this approach is only clinically useful when signatures are developed for the right question and when measured using rapid and reliable technology that delivers an answer at the point of need. Host Response, Inc. has translated host response molecular signatures onto diverse use-case dependent diagnostic platforms and is poised to transform clinical management of infectious and non-infectious disease.
2:20 Rapid Molecular Diagnostics for Sepsis
Esther Babady, PhD, Director, Clinical Microbiology Operations, Memorial Sloan Kettering Cancer Center
Sepsis remains a significant cause of morbidity and mortality in hospitalized patients. The current gold standard, blood culture, is limited by a slow turn-around time to results. Molecular methods for rapid diagnosis directly from blood samples are emerging. Additionally, several options for rapid diagnosis from positive blood cultures are now available. This presentation will review current and future options for rapid diagnosis of sepsis and discuss utility in patient care.
2:50 Lab in a Drop: An All-in-One Cartridge System for Point-Of-Care Multiomic Assays
Matt Trau, PhD, Professor of Chemistry; Director, Centre for Personalised Nanomedicine, University of Queensland; and Co-Founder, Xing Technologies
Modern medicine is currently transitioning to a new paradigm of precision and personalized care, where patients will be comprehensively screened and monitored for the detailed molecular abnormalities that characterise their specific disease. In the past decade, nanotechnology has provided new tools (e.g., next-generation sequencing) with unprecedented power to comprehensively interrogate genetic, transcriptomic and epigenetic information. Xing Technologies is focused on translating these new technologies into a clinical setting, whilst simultaneously developing the next generation of point-of-care diagnostic technologies to further empower personalised and precision medicine. To enable this, Xing Technologies has developed its “Lab in a Drop” technology for automated nucleic acid analysis within a single droplet of fluid, with minimal equipment and human interaction. This talk will feature the “Lab in a Drop” approach, along with future applications in proteomic, exosome and CTC analysis.
3:20 Refreshment Break in the Exhibit Hall with Poster Viewing (Independence Ballroom)
4:00 Clinical Needs and Current Challenges to Implementation of Point-of-Care and Rapid Testing to Improve Antimicrobial Stewardship in the Emergency Department
Larissa May, MD, MSPH, MSHS, Professor, Emergency Medicine; Director, Emergency Department Antibiotic Stewardship, University of California Davis
There has been an explosion in the development and availability of rapid tests to diagnose infectious diseases in acute care settings. Unfortunately, their promise has not yet been realized. While there are significant opportunities to implement these rapid tests for clinical use, their implementation must take into consideration alignment with clinical operations and workflows and provide a better solution to guide clinical decision making and improve patient safety and outcomes.
4:30 Metagenomic Sequencing for Infectious Disease Diagnosis and Surveillance
Charles Chiu, MD, PhD, 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) can enable detection of any pathogen – virus, bacteria, fungus, or parasite – in a single test. Applications of the mNGS approach include clinical diagnosis of infections (meningoencephalitis, sepsis, and pneumonia) in hospitalized patients and public health surveillance of emerging viruses. Efforts are underway to apply machine learning and deep learning approaches to diagnose infections on the basis of host response RNA-seq data.
5:00 Mixed Microbial DNA Reference Material for Metagenomics
Jason Kralj, PhD, Staff Scientist, Complex Microbial Systems Group, Biosystems and Biomaterials Division, Material Measurements Laboratory, NIST
Translating rapid advances in metagenomics to the fields of environmental, clinical, biomanufacturing, and biodefense applications requires rigorous characterization of the underlying technologies—informatics, sequencing, and sample preparation. NIST has engaged stakeholders in government, academia, and industry to help develop candidate reference materials (RM) that will help regulators, developers, and end-users evaluate metagenomics tools’ fitness for purpose. To deliver on that goal, the DNA from approximately 20 bacteria have been collected to form the basis of the RM. These DNA have been sequenced and quantified, the genomes assembled to improved high-quality drafts, and long-term stability analysis is underway. I will detail the methods and results of this characterization, and discuss potential methods of use and future areas for RM development.
5:30 Networking Reception in the Exhibit Hall with Poster Viewing (Independence Ballroom)
6:30 Close of Day
THURSDAY, AUGUST 23
7:15 am Registration (Independence Foyer)
7:30 Problem Solving Breakout Sessions with Continental Breakfast (Independence F-I)
Comparison of Reference Standards and Technologies for Clinical Next-Generation Sequencing in Infectious Diseases
Moderator: 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
- What are the advantages and disadvantages of various NGS platforms for infectious disease applications?
- When should NGS approaches be used, and when are faster and streamlined approaches (e.g. multiplex PCR, most appropriate)?
- What controls and standards need to be included?
- What bioinformatics programs and computational approaches be included?
Developing an Implementation Toolkit for Clinical Roll-Out of a New Diagnostic Test
Moderator: Kevin Messacar, MD, Assistant Professor of Pediatrics, University of Colorado/Children’s Hospital Colorado, Section of Infectious Diseases
- What strategies have been successful to help health care facilities implement new diagnostic technologies?
- How can you target a high-impact patient population for testing?
- What electronic medical record strategies have been successful for ordering and reporting?
- Who are key stakeholders to include in implementation?
- What are successful strategies to integrate new diagnostic technologies with antimicrobial stewardship teams and efforts?
Moderator: 
Heike Sichtig, PhD, Principal Investigator and Team Lead, Microbiology Devices, Center for Devices (CDRH), FDA
8:25 Regulatory Perspective
Eric F. Donaldson, PhD, Clinical Virology Reviewer, Co-Chair of the FDA Genomics Working Group Division of Antiviral Products, Office of Antimicrobial Products, Office of New Drugs, Center for Drug Evaluation and Research, Food and Drug Administration
8:35 Assay Development Perspective
Timothy D. Minogue, PhD, Chief, Molecular Diagnostics Department, Diagnostic Systems Division, USAMRIID
8:45 Clinical Implementation Perspective
Gary W. Procop, MD, Director, Molecular Microbiology, Parasitology, Virology Laboratories; Co-Chair, Enterprise Laboratory Stewardship Committee, Medical Operations; Processor of Pathology, Cleveland Clinic Lerner College of Medicine, Cleveland Clinic
8:55 Bioinformatics Perspective
Tom Slezak, Distinguished Member of the Technical Staff, Global Security Program, Lawrence Livermore National Lab
9:05 PANEL DISCUSSION
- What is the status of quantitative NGS as it is being used in the clinic?
- What is the role of bioinformatics?
- How to mitigate the issue of long, expensive assays
- Point-of-care
- Antimicrobial resistance
9:30 Implementing a Prior Auth Program – Choosing the Right Strategy for Your Lab
Walt Williams, Director, Revenue Optimization & Strategy, Revenue Cycle Services, Quadax
Policies have changed and understanding these changes is critical to choosing the right prior auth strategy for your lab. This presentation will compare the prior auth service models offered by a variety of vendors and, explore their impact on the claims adjudication and revenue cycle process for genetic/molecular claims subject to the prior authorization programs of Anthem and UnitedHealthcare. We will explore strategies for navigating prior auth that are most likely to get you paid, with the least disruption to your current processes. We will share analytic insights based on actual reimbursement trends that compare claims processing both with and without prior auth (including the increasing failure rate of appeals and overall reduction in reimbursement). The presentation will also highlight the latest payer trends including policy changes. New data and information is now available as these programs continue to evolve..
10:00 Coffee Break in the Exhibit Hall with Poster Viewing (Independence Ballroom)
11:15 am Chairperson’s Remarks
11:20 am - 12:00 pm TECHNOLOGY PANEL: Disruptive Technologies in Lab Medicine
Moderator: Gregory J. Tsongalis, PhD, HCLD, CC, Professor, Pathology; Director, Laboratory for Clinical Genomics and Advanced Technology (CGAT), Department of Pathology and Laboratory Medicine, Dartmouth Hitchcock Medical Center and The Audrey and Theodor Geisel School of Medicine at Dartmouth
- What is appropriate test utilization?
- How do you ensure both user and patient safety?
- How are tests implemented in the clinical setting?
- How do they get regulated?
- How do results get reported?
- How do you enforce quality control in implementation?
- How does it impact emerging applications such as liquid biopsies, infectious disease outbreaks, and POC diagnostics?
Panelists:
Rakesh Nagarajan, MD, PhD, Chief Biomedical Informatics Officer, PierianDx
Greg Richard, Chief Commercial Officer, Interpace Diagnostics
Crystal R. Icenhour, PhD, CEO, Aperiomics, Inc.
Additional Panelists to be Announced
12:00 - 12:45 pm Changing Approaches to Sustainable Funding in Diagnostics
Moderator: Bruce Quinn, MD, PhD, Principal, Bruce Quinn Associates
Today, many innovators in the diagnostics industry struggle for funding, and yet news of large scale acquisitions or large (over $30M) funding rounds pops up regularly. How can innovators better understand the changing dynamics of the funding environment to succeed? How can investors know if they are getting exposed to the potentially best investments? Whether government or private, what drives the final difficult decisions and how can companies raise their chances of success? This session features leaders from several different channels of funding for innovators, including the NIH, other federal programs, and corporate and traditional venture investors.
Panelists:
Alex DeWinter, PhD, Managing Director, GE Ventures
Tyler Merkeley, BARDA’s CARB-X Program Manager, Health Scientist, Division of CBRN Countermeasures, BARDA
Todd Haim, PhD, Program Director, National Cancer Institute SBIR Development Center
Wouter Meuleman, PhD, Director, Venture Investments, Illumina Ventures
12:45 pm Luncheon Presentation: Lyophilized qPCR Reagents: Advancing the Future of Molecular Testing (Farragut/Lafayette)
Junko Stevens, PhD, Senior Research & Development Director, Life Science Solutions Group. Research & Development, 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.
1:15 Close of Molecular Diagnostics for Infectious Disease
Recommended Dinner Short Course*
SC9: Microfluidics and Lab-on-a-Chip Devices for POCT: Technologies and Commercialization
Chris Myatt, Founder & CEO, MBio Diagnostics, Inc
Marta Fernandez Suarez, Daktari Diagnostics & FIND
Additional Instructors to be Announced
*Separate registration required