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Day 1  |  Day 2 



11:00 am-12:00 pm Registration 





(Shared session with Enabling Point-of-Care Diagnostics) 

12:15 pm Chairperson’s Remarks 

12:20 Clinical Diagnostics – Where Are We Going? 

Franklin R. Cockerill, III, M.D., Ann and Leo Markin Professor of Microbiology & Medicine; Chair, Department of Laboratory Medicine and Pathology, Mayo Clinic College of Medicine; President and CEO, Mayo Medical Laboratories and Mayo Collaborative Services, Inc. 

Significant advances in clinical diagnostics have occurred following the development of new technologies in the late 20th century and early 21st century. These technologies include immunoassays, nucleic acid amplification and sequencing methods, flow cytometry and mass spectrometry. Refinements and broad applications of these techniques, combined with information management, will promote personalized healthcare of high value.

12:50 New Developments in Rapid Molecular Testing for Respiratory Viruses 

Christine C. Ginocchio, Ph.D., M. T. (A.S.C.P.), Senior Director, Division of Infectious Disease Diagnostics, North Shore-LIJ Health System Laboratories; Associate Professor, Department of Pathology and Laboratory Medicine and Department of Molecular Medicine, Hofstra University School of Medicine in collaboration with the North Shore-LIJ Health System 

The timely identification of viral respiratory tract infections is of tremendous importance for diagnosis, appropriate patient management, reduction of the unnecessary use of antibiotics, and prevention of nosocomial transmission within health care settings. Comprehensive molecular diagnostic testing also provides key epidemiology and surveillance data and can rapidly identify outbreaks of novel viruses, as was demonstrated during the 2009 influenza A H1N1 pandemic. Novel new testing platforms and advanced multiplex technologies are now available to meet these diagnostic needs. This lecture will highlight the major advances in rapid molecular testing for respiratory viruses.

1:20 Luncheon Presentation
(Sponsorship Available) or Lunch on Your Own 



2:10 Chairperson’s Remarks 

Garth Ehrlich Garth D. Ehrlich, Ph.D., Professor of Microbiology and Immunology, Drexel University College of Medicine; Executive Director, Center for Genomic Sciences, Allegheny Singer Research Institute 

2:15 Rapid Identification of Bacteria, Mycobacteria, and Fungi by MALDI-TOF Mass Spectrometry

Pat Murray Patrick R. Murray, Ph.D., Chief and Senior Scientist, Clinical Microbiology Laboratory, NIH Clinical Center 

Conventional methods for the identification of clinically significant organisms is slow, expensive, and frequently inaccurate. Gene sequencing is highly accurate, but is currently slow, expensive, and technically demanding. In contrast, MALDI-TOF mass spectrometry is a rapid, inexpensive identification method that detects biomarker spectra characteristics for individual species of organisms with an accuracy equivalent to gene sequencing.

2:45 Mass Spec-Based Molecular Diagnostics Provide for Comprehensive Pathogen Screening

Garth Ehrlich Garth D. Ehrlich, Ph.D., Professor of Microbiology and Immunology, Drexel University College of Medicine; Executive Director, Center for Genomic Sciences, Allegheny Singer Research Institute 

The advent of the Ibis T-5000 Universal Biosensor has augured in a new era in molecular diagnostic pathogen detection and characterization. This technology provides the same breath as cultural techniques for all pathogen classes, and thus is useful for the identification of nearly any species without the need to a priori decide which pathogens to test for. However, it surpasses culture because it can detect any organism regardless of culturability, prior antimicrobial treatment, or metabolic state.

3:15 The Use of High-Resolution Melt Curve Analysis, Pyrosequencing, and DNA Profiling to Identify and Characterize Microorganisms

Gary W. Procop, M.D., M.S., Chair, Department of Molecular Pathology; Section Head, Molecular Microbiology; Director, Mycology, and Parasitology; Professor of Pathology, Cleveland Clinic 

The genomes of medically-important microorganisms are becoming well characterized. This data is providing evidence of unique or signature sequences that can be used for microorganism identification and characterization. In many instances, such information is contained within short segments of DNA, with even single nucleotide polymorphisms providing important information. This information may be obtained using modern molecular techniques that are simple to perform and inexpensive.

3:45 Networking Refreshment Break, Exhibit & Poster Viewing 

4:30 Mass Spectrometry-Based Diagnostics for Medical Microbiology 

Donna Wolk Donna M. Wolk, Ph.D., D(ABMM), Associate Research Professor, BIO5 Institute, Division Chief for Clinical and Molecular Microbiology, Department of Pathology, Arizona Health Science Center and University Medical Center 

The introduction of mass spectrometry methods into clinical microbiology laboratories brings many possibilities for new clinical laboratory interventions in support of patient care. This program will describe and review mass spectrometry methods with current and potential application to diagnostic clinical microbiology laboratories.

5:00 Sequencing-Based & Mass Spectrometric Bacterial Identification in Clinical Microbiology

Robin PatelRobin Patel, M.D.(CM), FRCP(C), (D)ABMM, FACP, Consultant, Divisions of Clinical, Microbiology and Infectious Diseases, Professor of Microbiology and Medicine, College of Medicine, Mayo Clinic 

Identification of bacteria isolated from clinical specimens provides valuable information for patient care, but is challenged by microbial diversity. Traditional methods rely on conventional biochemicals, used either manually or in an automated application. In this presentation, DNA sequencing- and matrix-assisted laser desorption ionization–time of flight mass spectrometry-based bacterial identification for use in clinical laboratories will be explored.

5:30 Break-Out Sessions

The roundtable discussions open to all attendees, sponsors, exhibitors, and speakers provide a forum for discussing key issues and meeting potential partners. Plan to take part and explore the topics in-depth.

Emerging and Novel Technologies for Infectious Molecular Diagnostics 

Moderator: Gary W. Procop, M.D., M.S., Cleveland Clinic

  • What are the advantages and limitations of mass spec technology in microbiology
  • What is next for nucleic acid sequencing in clinical microbiology and infectious diseases
  • Are there advantages to mass spec sequencing over conventional or pyrosequencing

The Business of Molecular Diagnostics 

Moderator: Daniel R. McClernon, McClernon, LLC

  • Moving diagnostic assays from development towards external clinical applications
  • Importance of assay or product "freeze" for commercialization
  • Monitoring of competition-Does it matter?
  • High volume vs. niche diagnostic testing

Molecular Diagnostics for Infectious Viral Agents 

Moderator: Christine C. Ginocchio, Ph.D., M.T. (A.S.C.P.), North Shore-LIJ Health System 

  • How can we improve physician acceptance of broad viral diagnostics for respiratory pathogens?
  • When are quantitative molecular assays for respiratory pathogens indicated?
  • Will standaridization of quantitative molecular assays for respiratory viruses be possible?
  • How can we assist manufacturers in bringing viral diagnostic assays through the FDA clearance process?
  • To be clinically effective, do viral diagnostics need to be brought to the bedside, and at what cost in reagents, time, assay sensitivity and specificity?

6:30 End of Day 


6:30 - 8:30 Dinner Short Course* 


  • How are Dx POCT markets changing? 
  • Which platforms will win? What’s going to happen to the big box diagnostic companies? 
  • Hospital, MD offices, or home? 
  • What are the bottlenecks as markets change? 
  • Where will the new markets be and how will they be organized? 
  • What strategies make sense for Dx and POCT companies? 


Keith F. Batchelder, Chief Executive Officer, Genomic Healthcare Strategies 

Peter S. Miller, Chief Operating Officer, Genomic Healthcare Strategies 

*Separate registration required. Click here for details.


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