Molecular testing technologies continue to evolve at a rapid pace. The field of clinical microbiology is undergoing rapid change with novel molecular technologies cutting the time needed to diagnose infections, enabling more precise and appropriate individualized therapies, improving patient care and optimizing clinical outcome. This field is on the cusp of the largest change in its history. The 2015 Molecular Diagnostics for Infectious Disease conference will highlight several emerging and cutting-edge technologies and discuss some of the hurdles for their regulation and integration into clinical practice. We will continue to track the progress of those working with NGS for ID and provide in-depth coverage of the challenge with diagnostic testing in sepsis.

WEDNESDAY, AUGUST 19

10:30 am Registration

12:40 pm Luncheon Presentation: Empowering In-Office Treatment Decisions with Point-of-Care Molecular Diagnostic Testing

Shana Kelley, Ph.D., CTO, Xagenic Inc.

Ihor Boszko, Vice President, Business Development, Xagenic Inc.

Point-of-care MDx testing is finally available in 2015, and it unlocks a huge opportunity for improvement of clinical outcomes and reduction of healthcare costs by delivering better diagnostic tools for physicians.  Xagenic has developed the enzyme-free, highly multiplexed Xagenic X1™ platform that boasts a time to result of 20 minutes with a low cost of adoption. Our strategy will bring to market a menu of infectious disease tests with greatest utility for clinical decision-making during the initial patient visit.

1:25 Refreshment Break in the Exhibit Hall with Poster Viewing

MOLECULAR POINT-OF-CARE TESTING FOR ID

1:50 Chairperson’s Opening Remarks

Kate Simon, Ph.D., Senior Consultant, Biologics Consulting Group, Inc.

2:00 Point-of-Care Is Invading Microbiology

Nathan A. Ledeboer, Ph.D., D(ABMM), Assistant Professor, Medical Director, Clinical Microbiology, Medical College of Wisconsin

Development of point-of-care molecular assays for the detection of infectious diseases is rapidly expanding. The assays being released exhibit variable sensitivity and specificity, leaving providers to understand the limitations of point-of-care testing. This session will explore the utility of various assays for the point-of-care market from the standpoint of outcomes, contribution to value added care, and assay performance.

NEW & IMPROVED MOLECULAR TESTING – CLINICAL APPLICATION & EVALUATION

2:30 The Impact of Molecular Tests on the Management of Pneumonia

Thomas M. File, Jr., M.D., MSc, MACP, FIDSA, FCCP, Chair, Division of Infectious Disease, Summa Health System; Professor, Internal Medicine, Master Teacher, Chair, Infectious Disease Section, Northeast Ohio Medical University

The utility of standard diagnostic studies to determine the etiologic agents of pneumonia has been controversial in part because of the lack of rapid, accurate, easily performed, and cost-effective methods. Advancements in molecular testing methods have brought forth new potentials for diagnosis which might allow results for most patients at the initial point of service, including in an office setting, and result in better patient outcomes.

3:00 Host Gene Expression Classifiers Diagnose Acute Respiratory Illness Etiology

Ephraim L. Tsalik, M.D., MHS, Ph.D., Assistant Professor, Medicine, Division of Infectious Diseases, Center for Applied Genomics & Precision Medicine, Medicine, Duke University School of Medicine

Host gene expression changes are exquisitely specific to the offending pathogen class. Their ability to discriminate common etiologies of respiratory illness is quantifiable and robust. This creates an opportunity to develop and utilize gene expression classifiers as novel diagnostic platforms with broad downstream implications including improvements in antibiotic stewardship and precision medicine.

3:30 A Molecular Host Response Assay to Discriminate Between Infection-Positive and Infection-Negative Systemic Inflammation in Critically Ill Patients

Therese Seldon, Vice President, Operations, Immunexpress

Traditional diagnosis of sepsis is based on detecting pathogens from microbial culture. Newer molecular methods of pathogen detection continue to emerge, yet miss an important part of the sepsis diagnostic picture; the ability to trust a negative result. Analysis of the host immune response provides an alternative approach to diagnosing sepsis. SeptiCyte® Lab, a new host response test showed an area under curve >0.9 with better performance than Procalcitonin in a large, prospective, multisite study.

4:00 Refreshment Break in the Exhibit Hall with Poster Viewing

NGS SEQUENCING FOR ID

4:45 NGS Assays for Diagnosis of Infectious Diseases

Charles Chiu, M.D., Ph.D., Associate Professor, Lab Medicine and Infectious Diseases; Director, UCSF-Abbott Viral Diagnostics and Discovery Center; Associate Director, UCSF Clinical Microbiology Laboratory

There is great interest and potential in the use of metagenomic next-generation sequencing (NGS) for diagnosis of infectious diseases in clinical settings. We will discuss assay development, clinical validation, bioinformatics analysis, and regulatory considerations involved when developing such NGS-based assays in CLIA-certified laboratories. We will also discuss emerging rapid, point-of-care sequencing technologies and host-based approaches for infectious disease diagnosis.

5:15 Genomic Insights into the Epidemiology of Healthcare-Associated Infections

Evan Snitkin, Ph.D., Assistant Professor, Microbiology and Immunology, Medicine, Division of Infectious Diseases, University of Michigan Medical School

Whole-genome sequencing provides the ultimate resolution in molecular typing. This resolution is yielding critical insights into the spread of healthcare-associated infections and will have a major impact on the future of infection prevention.

5:45 Regulatory Perspective on Infectious Disease NGS Dx Devices

Heike Sichtig, Ph.D., Medical Countermeasures / Multiplex, Microbiology Devices, Center for Devices (CDRH), FDA

The presentation will outline studies to evaluate the use of NGS-based devices as an aid in Infectious Disease diagnostics, and to gain a better understanding of potential NGS clinical implementation strategies. Focus will be on the possible approaches to validation studies and data for the evaluation of infectious disease NGS-based diagnostics for potential regulatory clearance/approval, and the use of sequence outputs from infectious disease NGS-based devices to evaluate performance. Efforts towards generating an initial set of high quality, regulatory-grade microbial genomic reference sequences through the FDA-ARGOS project in collaboration with NCBI will also be discussed. Our vision is a high quality ‘regulatory-grade’ microbial reference database that contains qualified sequence data for use by developers and clinical end users. The information contained in the presentation concerning possible approaches for validation are suggested approaches open for feedback.

6:15 Close of Day

6:00 Dinner Short Course Registration

THURSDAY, AUGUST 20

NGS SEQUENCING FOR ID

8:25 Chairperson’s Opening Remarks

Reiner Babiel, Ph.D., Executive Director, Consulting, RBDC

8:30 Whole Genome Sequencing of Microbes in the Clinical Laboratory

Randall J. Olsen, M.D., Ph.D., Associate Member, Center for Molecular and Translational Human Infectious Diseases Research, Houston Methodist Research Institute

Our molecular diagnostics laboratory recently validated and implemented whole genome sequencing of microbes as a clinical test. I will discuss how we routinely use whole genome sequencing in our clinical laboratory to assign a taxonomic classification to unknown organisms, assess genetic relationships among epidemiologically linked strains, and identify the molecular basis of severe, unusual or interesting infections.

8:50 Acute Life-Threatening Infections: Sequencing in Emergency

Ivan Brukner, Ph.D., Molecular Diagnostics Lab Director, Medical Diagnostics, Jewish General Hospital

The most common deadly viral, bacterial and fungal infections present in urine, plasma and SCF (cell-free DNA). Antithetical coverage of what can be done now, and which methods to use will be presented as well as a special overview of detecting unknown DNA pathogen and what is needed to cover RNA pathogens.

ANTIMICROBIAL RESISTANCE – ANTIMICROBIAL STEWARDSHIP

9:10 Antibacterial Resistance Leadership Group Master Protocol for Diagnostic Studies: A Better Path Forward

Ephraim L. Tsalik, M.D., MHS, Ph.D., Assistant Professor, Medicine, Division of Infectious Diseases, Center for Applied Genomics & Precision Medicine, Medicine, Duke University School of Medicine

The Antibacterial Resistance Leadership Group (ARLG) prioritizes, designs, and executes clinical research that will reduce the public health threat of antibacterial resistance. Among the ARLG’s pillars is the advancement of diagnostic testing, which in turn can decrease unnecessary antibacterial use, inform antibiotic stewardship, and positively impact on antibacterial resistance. The ARLG has developed a Master Protocol concept driven by the principle that one patient can contribute multiple samples for the simultaneous evaluation of multiple diagnostic platforms. This strategy lowers costs for all involved, improves operational and scientific efficiency, and standardizes definitions and procedures. The ARLG is also uniquely positioned across multiple realms including academia, industry, NIH, and FDA. These and other resources offer a new path forward to promote diagnostics development.

9:30 Relying on the Most Accurate System to Diagnose Infections…Your Immune System

Eran Eden, CEO, MeMed

Bacterial and viral infections are often clinically indistinguishable, leading to antibiotic misuse. To adress this challenge a pioneering test called ImmunoXpert™ was developed, which accurately distinguishes between bacterial and viral infections based on a patient’s immune response. ImmunoXpert™ empowers physicians to make better antibiotic treatment decisions.

9:45 Utility of Rapid Real-Time PCR using a Novel Random-Access 20-Minute Real-Time PCR System

 Chris Connelly, Ph.D., Research and Development Scientific Manager, Molecular Technology, Streck

This talk will focus on PCR-based applications for the Philisa® Real-Time PCR System that serve to accelerate workflow for molecular diagnostic analysis. Critical assays for infectious disease testing, such as detection of antibiotic resistant bacteria and RT-PCR-based identification of viruses will benefit from the versatility and performance of the Philisa Real-Time PCR System.

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

10:50 Utilizing Molecular Diagnostics to Enhance Antimicrobial Stewardship

Jerod Nagel, Pharm.D., BCPS (AQID), Clinical Specialist, Infectious Diseases, Clinical Assistant Professor, Director Infectious Diseases Residency, University of Michigan Hospital and Health Systems, University of Michigan, College of Pharmacy

Antimicrobial stewardship programs have a dramatic impact on antimicrobial prescribing. Programs that incorporate molecular diagnostics as part of the decision paradigm, can improve timeliness of appropriate antimicrobial prescribing, reduce cost and improve patient outcomes. This presentation will examine the integration of molecular diagnostics within antimicrobial stewardship programs and the impact on antibiotic utilization.

11:10 Antibiotic Stewardship: A National Priority

Lori A. Pollack, M.D., MPH, Medical Officer, Division of Healthcare Quality Promotion, Centers for Disease Control and Prevention

As responsible stewards of antibiotics, we need to use antibiotics only when necessary and to use the right antibiotic when one is needed. These strategies not only improve patient outcomes but also prevent transmission of resistant pathogens Novel diagnostics to identify an infectious agent, to detect resistance mechanisms and to guide definitive therapeutic decisions have the potential to significantly improve antibiotic use. In this presentation, we will discuss efforts to measure antibiotic use and where diagnostics can make the biggest impact.

DIRECT DETECTION FOR SEPSIS – NEXT STEPS

11:30 Novel Approaches to the Laboratory Diagnosis of Sepsis

Jennifer Dien Bard, Ph.D., D(ABMM), FCCM, Assistant Professor, Clinical Pathology, Keck School of Medicine, University of Southern California; Director, Clinical Microbiology Laboratory; Acting Director, Clinical Virology Laboratory, Pathology and Laboratory Medicine, Children’s Hospital Los Angeles

Sepsis is associated with high morbidity and mortality. Prompt microbiological workup that guide appropriate antimicrobial therapy is essential for the optimization of patient outcome. Novel, innovative technologies have revolutionized the detection and identification of bloodstream pathogens in the laboratory. This session discusses approaches to rapid diagnosis of sepsis.

11:50 Integrative ‘Omics Analysis of Sepsis: Biomarkers for Improved Patient Management

Raymond J. Langley, Ph.D., Assistant Professor, Department of Pharmacology, University of South Alabama

Infection-induced severe sepsis patients who do not receive early therapy have a high mortality rate (55%). However, current diagnostics are fairly non-specific. We used an integrative ‘omics approach to develop a clinico-metabolomic classifier to predict sepsis and the probability of death at the time of presentation.

12:20 pm Luminex® ARIES™ and NxTAG™ Platforms—The New Standard for Clinical Diagnostics

Sherry Dunbar, Ph.D., Director, Scientific Affairs, Luminex Corporation

Learn the latest in Luminex Technology. ARIES™, the sample-to-answer real-time PCR platform of the future, integrates seamlessly into the molecular diagnostics lab, increasing efficiency and productivity. NxTAG™, our next generation multiplexing technology for MAGPIX®, provides a closed-tube solution for bead-based multiplexing, with streamlined workflow and robust performance. We will share the latest updates on these exciting new platforms, including some preliminary data from clinical sample testing.

12:35 Sponsored Presentation (Opportunity Available)

12:50 Luncheon Presentation (Sponsorship Opportunity Available) or Enjoy Lunch on Your Own

1:20 Session Break

DIRECT DETECTION FOR SEPSIS (CONT’D)

2:00 Chairperson’s Remarks

Raymond J. Langley, Ph.D., Assistant Professor, Department of Pharmacology, University of South Alabama

2:05 Utility of the Abbott PCR/ESI-MS (Iridica) in Diagnostic Microbiology: Results of a Multicenter Trial for the Rapid Diagnosis of Sepsis

Mark Wilks, Ph.D., Lead Clinical Scientist, Microbiology, Barts Health NHS Trust

Abbott PLEXiD (now Iridica) is the first commercially available CE marked system for the direct diagnosis of ID directly from the clinical specimen. A Europe wide multicentre trial has recently been concluded and should hopefully be published before the conference.

NOVEL TECHNOLOGIES & APPROACHES

2:35 Biologically-Inspired Engineering of the Human Innate Immune System for the Diagnosis and Therapy of Infectious Diseases

Michael Super, Ph.D., Senior Staff Scientist, Advanced Technology Team, Wyss Institute, Harvard University

We have engineered PAMPs-binding proteins (e.g. FcMBL) on solid supports to capture fungi, bacteria, viruses, parasites and toxins from complex media. We use the engineered FcMBL for pathogen identification using molecular and protein analysis and we have successfully treated septic rats and pigs using FcMBL in an extracorporeal dialysis-like-therapy (DLT).

3:05 Rapid Pathogen ID on Existing MALDI-TOF-MS Systems

David R. Goodlett, Ph.D., Issac E. Emerson Professor, Pharmaceutical Sciences, School of Pharmacy; Mass Spectrometry Facility Director, University of Maryland

Current progress in pathogen detection is limited primarily because of the time required to grow the pathogens to a detectable level. UMB inventors have developed a lipid-based rapid, accurate and automatable method of pathogen detection that may be deployed on existing MALDI-TOF-MS instruments already becoming popular in diagnostic laboratories for pathogen identification based on high abundance protein profiles.

3:35 PANEL DISCUSSION: Looking at the Future of Emerging Technologies for Infectious Disease Detection and Diagnosis

Moderator: Michael Super, Ph.D., Senior Staff Scientist, Advanced Technology Team, Wyss Institute, Harvard University

Panelists:

Raymond J. Langley, Ph.D., Assistant Professor, Department of Pharmacology, University of South Alabama

Sherry Dunbar, Ph.D., Director, Scientific Affairs, Luminex Corporation

David R. Goodlett, Ph.D., Issac E. Emerson Professor, Pharmaceutical Sciences, School of Pharmacy; Mass Spectrometry Facility Director, University of Maryland

Mark Wilks, Ph.D., Lead Clinical Scientist, Microbiology, Barts Health NHS Trust

4:05 Close of Conference