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Register
by July 16th and SAVE up to $200!
8:00 am Registration and Morning Coffee
8:20 Chairperson’s Comments
Matthew Lorence, Ph.D., M.B.A., Vice President, Marketing and
Sales, Tessarae, Inc.
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8:30 Technologies for the Detection, Identification and
Monitoring of Infectious Diseases – Future Trends,
Challenges and Solutions
Penny Wilson, Ph.D., Independent Consultant, Diagnostic
Specialist
The UK Office of Science and Innovation has recently completed
a Foresight project on the Detection, Identification and
Monitoring of Infectious Diseases (DIM). The program utilized over
450 experts from a diverse range of disciplines, and benefited
from the inclusion of plant, animal and human diseases.
The ultimate goal is to achieve an integrated network for the DIM
of all known and unknown pathogens. It is envisaged that POC
devices will play a significant, and increasingly vital role, in
the DIM of infectious diseases over the next 20 years; and that
advances will benefit the developed and developing world. With
particular reference to POC devices, an overview of the
technological trends and their implications, in the light of
future risks, will be presented.
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9:00 Integration of Genomic Technologies in Clinical
Practice: Development of Standard Controls and Best
Practice Guidelines
Janet A. Warrington, Ph.D., Vice President, Research and
Development, Affymetrix Inc.
Increased access to genomic information is transforming the
drug and diagnostics development process and giving life to the
vision of integrating molecular,
genetic and clinical information to improve healthcare. Research
and development efforts focused on using microarray technology to
identify and measure the genetic information associated with
complex disease are evolving into clinical studies and trials
geared toward development of new tools for the clinic. Successful
adaptation of this technology into routine clinical practice also
requires establishing consensus on quality, interoperability,
standard controls and best practice guidelines. Multiple
international standards development efforts are underway that will
accelerate acceptance and adoption of microarray technology in
clinical studies, clinical trials and diagnostics. A number of
these initiatives will be described including the efforts of the
External RNA Controls Consortium, the American Health Information
Community and the Clinical and Laboratory Standards Institute. |
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9:30 Translating Genome Technologies to Point-of-Care -
The other "Valley of Death"
Klaus O. Schäfer, M.D., MPH, President & CEO, Tessarae
Inc./LLC
Transitioning technology from high-end research laboratory use
and translating the technology to eventual Point-of-Care is
fraught with enormous difficulty and
faces its own "Valley of Death" similar to bringing
pharmaceuticals to the marketplace within the pharmaceutical
industry. This overview will look at the challenges facing teams
trying to transition technologies from the research bench to their
eventual use in the POC diagnostics area. Specific examples will
highlight moving PCR techniques and high-throughput microarrays
towards eventual POC use within the government by technology pull.
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10:00
POC Diagnostics In Real-World Samples - Surface Enhanced
Raman Scattering (SERS) Nanoparticles For Ultrasensitive,
Multiplexed Immuno And DNA Assays
Michael Natan, Ph.D., President & Chief Technical Officer, Oxonica Inc.
Nanoplex™ biotags are silica-encapsulated 50nm gold
nanoparticles that exhibit the optical effect of Surface
Enhanced Raman Scattering (SERS) due to the presence of a
reporter molecule at the silica-gold interface. SERS is
inherently multiplexable and is ultrasensitive in comparison
to standard optical detection methods, but is completely
immune to interference from biological materials.
These characterstics of SERS in a nanoparticle structure
permits novel assay formats that address the current
requirements of next-generation POC diagnostics. We present
two different POC formats utilising SERS-active biotags. A
quantitative, multiplexed LFI rapid test for three
respiratory pathogens and a homogeneous 2-plex, cardiac
diagnostic with pg/ml sensitivity. |
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10:15 Sponsored Workshop (Sponsorship
Available)
10:30 Poster Session with Coffee and Exhibit Viewing
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11:00 Molecular Diagnostics in the POC Setting - A
Reality at Last
Emily S. Winn-Deen, Ph.D., Vice President, Strategic
Planning and Business Development, Cepheid
Until recently, molecular diagnostic testing has been
restricted to high complexity labs with the specialized staff
trained to design and run these assays. Cepheid’s full
sample in-answer out automation is now making molecular
diagnostic testing available to all hospitals, as well as to
moderate complexity physician office and clinic settings. At
last, physicians can order molecular tests and labs can run
them on-demand, providing for more timely medical management
of patients. |
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11:30 Miniaturization and Integration of Clinical
Chemistry and PCR-Based Nucleic Acid Testing Platforms
Lucy Lu, Ph.D., Vice President, Technology Management,
Head, US Chief Technology Office, Roche Diagnostics
Miniaturization and Integration of Clinical Chemistry and PCR-Based
Nucleic Acid Testing Platforms
The presentation will describe Roche Diagnostics’ recent
development on microfluidics-based platforms for clinical
chemistry and nucleic acid testing. Various technical and
market challenges will be discussed from a diagnostic supplier’s
viewpoint.
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12:00 Luncheon Workshop (Sponsorship Available) or Lunch on
Your Own
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1:15 Chairperson’s State of the Industry Address
Harry Glorikian, Managing Partner, Scientia Advisors
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1:30 Emerging Capabilities for Biological Sensing -- Towards
Multimodal Sensing
Eric Van Gieson, Ph.D., Program Manager, Johns Hopkins
Applied Physics Laboratory
The discussion will outline the challenges that will be faced
with a new generation of sensing devices that combine protein
recognition with nucleic acid recognition. The highlighted themes
will be the ability to intelligently combine sensing outputs using
advanced fusion algorithms, designing the sensing components to
rapidly change assay formats, and creating a sample preparation
capability that will cater to all of the sensing components. |
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2:00 Development of an Advanced Portable PCR System
that Utilizes Automated Sample Preparation and Highly
Multiplexed Assays
Jay Lewington, Ph.D., Director, Biological Detection
Technology, Smiths Detection
Smiths Detection has developed a portable PCR instrument and
automated sample preparation consumable specifically for
veterinary and environmental monitoring. The device has four
independently controlled thermal cyclers, each of which has six
optical channels, allowing for highly multiplexed reactions, and
the device is water-tight, which allows for decontamination via
submersion. The sample preparation consumable is driven by the
instrument after the sample is loaded by the user and contains
lyophilized reagent that are stable for over one year at room
temperature. The system also utilizes a novel PCR amplification
methodology that enables the reliable multiplexing of 10 – 20
target organisms. While this system was developed for other
applications, Smiths Detection believes that this system could
provide significant benefits within the Point-of-Care market.
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2:30 Differential Diagnostics of Rare vs. Common
Pathogenic Agents: Finding the Zebras Among the Horses
Michael Londner, M.D., MPH, MBA, Assistant Professor,
The Johns Hopkins University School of Medicine
Emergency room physicians treat patients presenting similar
symptoms that could be caused by a variety of bacterial and viral
infectious agents. Differentiating an exceedingly rare case of
pulmonary Anthrax (zebra) from a common upper respiratory
infection like Influenza (horse) during the Flu season, is a
daunting task. To date, no single test is available to provide
physicians with the information necessary to distinguish such
possibilities. The diagnostic device requirements from the
perspective of the ER physician and the benefits for patient
treatment will be discussed. |
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3:00 Poster Session with Refreshments and Exhibit
Viewing |
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3:30 Designing Affordable In Vitro Diagnostics
for the Developing World
David M. Kelso, Ph.D., Associate Professor, MCC Biomedical
Engineering, Northwestern University
Unlike high-income countries, the cost of an in vitro
diagnostic test is the dominant requirement for the developing
world. To deliver the benefits of near-patient testing to
healthcare providers in resource limited settings, we must design
devices that reduce overall costs. Systems developed explicitly
for low-income markets will be less complex, more reliable, and
robust than those designed for high-income markets. Design
decisions driven by cost per test will lead to very different
platform architectures. |
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4:00 Microfluidic Microarray Compact Disc (CD) for POCT
Michel G. Bergeron, M.D., Director, Centre de Recherche en
Infectiologie, CHUQ pavillon CHUL
This talk will summarise the recent technologies we developed
for rapid detection and identification of infectious agents. These
technologies include CD-based cell lysis and nucleic acid
extraction devices, sensitive microfluidic PCR, automated
ultrarapid hybridization of microarrays and dedicated optical
instrumentation. Future approaches explored by our team, such as
the use of polymeric biosensors to detect DNA and nanotechnologies
for pathogen capture and nucleic acid purification will also be
discussed. |
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4:15 Point-of-Care Bacterial Immunoassay
Mr. Jim Fleming, Chief Technology Officer, Research and
Development, GenPrime, Inc.
GenPrime has developed a point-of-care immunodiagnostic device
to screen platelet concentrates for bacterial contamination prior
to transfusion, the BacSTAT. The design is based on a lateral flow
dipstick format and incorporates a unique capture line capable of
detecting any antibody-bacteria complex. The current configuration
can detect 15 separate organisms on a single strip. The rapid test
is coupled with an optical reader that provides objective
determination of results and automated data management. The
BacSTAT should find wide application in point-of-care testing
where rapid screening for bacterial contamination is required.
4:30 Genomic Barcoding of Lethal Pathogens and
Infection Biomarker Discovery
Willy Valdivia-Granda, CEO, Orion Integrated Biosciences Inc.
Pathogen infections take many forms from the mildly
debilitating flu, which kills millions of people every year, to
the violently fatal encephalitic and hemorrhagic fevers such as
Ebola virus which has 90% lethality. The potential use of many of
these pathogens as bioweapons represents a serious risk to global
security. To address these challenges, we present an integrated
approach for point-of-care diagnostics. Our approach combines
advances in genomics, nanofabrication and bioinformatics to
analyze the genome of multidrug resistant bacteria and encephalic
and hemorrhagic viruses. The information generated from this
genomic barcoding process is incorporated in nanowire and
microarray detection systems. In parallel, we use host molecular
responses to identify early infection biomarkers. The integration
of these data types for the characterization of tularemia, plague,
smallpox, Ebola, and H5N1 influenza will be presented. The
challenges and future directions will be discussed.
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4:45 Vision for Decentralized Molecular Diagnostics and Closing
Remarks
Shuqi Chen, Ph.D., Chief Executive Officer, IQuum, Inc. |
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5:00 Close of Conference
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