Exhibitor Workshops

MONDAY, 1:15PM–2:45PM

Translating Analytical Performance Into Clinical Impact For Patients: Learn How Sigma Difference In Performance Can Impact Viral Load Results
Supported by Abbott
Hilton, Coquina D
Boxed Lunch will be served.

Speakers:
Sten Westgard, MS; Westgard QC, Inc.
John McKinnon, MD, MSc; Henry Ford Hospital

Overview:
Sten Westgard, MS, of Westgard QC, Inc. will discuss how analytical quality is impacted by assay performance and what it takes to be Six Sigma. John McKinnon, M.D. will highlight why a higher-Sigma performing assay delivers actionable results for best patient outcomes.

 

Reliable Quality Control and Complete Automation for qPCR Analysis
Supported by Azure PCR
Hilton, Halifax BC
Lunch will be served.

Speaker:
Aron Cohen; CEO, Azure PCR

Overview:
Using automation, the Azure PCR platform is designed to maximise quality control whilst reducing costs of all aspects of real-time PCR (qPCR) data-analysis. As well as providing immediate sample classification and quantification results from thermocycler data, our routine analysis can automate rule-based monitoring (such as the ‘Westgard’ rules or comparing target results/CTs for a final assay outcome) and provide recommendations such as intermittent control or dilution runs based on fully customisable laboratory performance guidelines. Our system is unique in that it is both automated and also able to determine when samples or runs need to be reprocessed.  Ensuring adequate levels of quality control for qPCR analysis can place a high load on experienced technicians and consequently has an impact on laboratory resource usage. However, due to the high prevalence and throughput of qPCR, and its impact on clinical decision making, it is crucial that laboratory directors and scientists are confident in results being produced.  In order to achieve this, Azure PCR provides a guided workflow that we perform, together with the laboratory scientists, to ensure that the system routinely makes the same decisions as they would themselves, automatically. This enables a one-time calibration per assay, including customising reports, rules and any other aspect which results in automated LIMS importable reports for routine qPCR testing for any application. We will demonstrate this workflow and the expected outcomes for the lab at our presentation.

 

The BioFire FilmArray® Gastrointestinal Panel for Pediatric Acute Gastroenteritis; Meningitis/Encephalitis Panel Clinical Study Experience.
Supported by BioFire Diagnostics
Hilton, Coquina A & B
Refreshments will be served.

Speaker:
Amy L. Leber, PhD, D(ABMM); Director, Clinical Microbiology and Immunoserology, Department of Laboratory Medicine Nationwide Children’s Hospital

Overview:
The FilmArray Gastrointestinal (GI) Panel received FDA-clearance in May, 2014. With one test, you can identify up to 22 common gastrointestinal pathogens including viruses, bacteria and parasites that cause infectious diarrhea. The integrated FilmArray system brings sample to results in about an hour, with only 2 minutes of hands-on time. This workshop highlights the clinical utility of the GI Panel through a retrospective analysis. BioFire’s next panel, the Meningitis/Encephalitis Panel, is undergoing clinical evaluation; one study site will share their experience. For additional information, please visit BioFire Diagnostics’ Booth (#301) or www.FilmArray.com.

 

Unlocking the Future of Infectious Disease Diagnostics: The GenMark Solution
Supported by GenMark Diagnostics
Hilton, Coquina C
Refreshments will be served.

Overview:
GenMark’s passion for developing diagnostic innovations has led to rapid advances in management of infectious diseases, improved laboratory workflow, and output of the clinical laboratory to transform patient care. In this workshop you will learn about:
• The current molecular landscape and today’s key challenges
• GenMark’s ePlex™ sample-to-answer system, combining eSensor® and electrowetting technologies
• The role that sample-to-answer diagnostics can play in empowering your lab to deliver fast, actionable results.

 

Evaluation of the NxTAG™ Respiratory Pathogen Panel: The Next Generation Multiplex Respiratory Testing Solution from Luminex Corporation by Dr. Yi-Wei Tang from Memorial Sloan Kettering Cancer Center
Supported by Luminex
Hilton, Crystal Room
Refreshments will be served.

Speaker:
Yi-Wei Tang , MD, PhD, F(AAM), FIDSA; Chief, Clinical Microbiology Service, Memorial Sloan Kettering Cancer Center

Overview:
This study evaluates the performance of the NxTAG™ Respiratory Pathogen Panel on nasopharyngeal swab (NPS) specimens collected from patients with symptoms of respiratory tract infections. The performance, scalability of 1 to 96 reactions per batch, and workflow makes NxTAG™ an appropriate platform when a high throughput testing is needed during burdensome influenza seasons and pandemics. Luminex will also provide insight into its exciting, new Sample-to-Answer system, ARIES®. We will include a system overview, updated timelines, and introduce the multi-functional SYNCT™ software, used for analysis of both NxTAG™ and ARIES® assays.

 

New Enabling Luminescent Technologies for Viral Research and Antiviral Therapy Development and Testing
Supported by Promega
Hilton, Halifax A
Refreshments will be served.

Speaker:
Robert Brazas, PhD; North America Market Manager, Promega Corporation

Overview:
Luminescent reporter genes, such as firefly luciferase, are powerful tools used to create reporter viruses and cell lines that allow investigators to rapidly and easily monitor viral infection and spread using simple luminescent assays. With these tools in hand, investigators study the basic mechanisms of viral replication, packaging, spread and more, while others use these reporter viruses to develop and test anti-viral therapies. Importantly, each reporter virus must behave as close to its wild type virus cousin as possible in order to generate the most relevant and useful data. Unfortunately, not all viruses are amenable to the incorporation of reporter genes into their genomes and become highly attenuated, or in other cases, viruses will tolerate the gene insertions, but the expression of the reporter gene will be so low that the reporter virus is not useful. This workshop will introduce a new reporter, NanoLuc® Luciferase, which due to its extremely bright signal and small size, overcomes many of the challenges associated with the development of useful reporter viruses and assays. In addition, we’ll introduce a new luminescent binary reporter system, NanoBiT™, which enables a variety of assays such as protein-protein interactions previously not possible with single reporter protein systems. Specifically, this workshop will describe the NanoLuc® Reporter and NanoBiT™ Systems, three NanoLuc® Reporters available (stable, destabilized and secreted), as well as provide data examples demonstrating the versatility and utility of these novel reporter systems for challenging viral applications.

 

Redefining Near Patient & MDx Testing: Quidel’s Sofia & HDA Platforms
Supported by Quidel Corporation
Hilton, Coquina F
Refreshments will be served.

Speakers:
Charlotte Gaydos, Dr, PH; Professor, Division of Infectious Diseases, Medicine, Johns Hopkins University
Huimin Kong, PhD; President, BioHelix
Barbara Rath, MD, PhD; Department of Pediatrics, Division of Pediatric Infectious Disease, Charite University Medical Center, Berlin, Germany
Wallace Greene, PhD; Director, Clinical Virology, Hershey Medical Center
Lauren Grippa; Sr. Clinical Research Associate, Quidel Corporation

Overview:
In this workshop you will learn about Quidel’s latest advances in molecular detection with AmpliVue® and be introduced to our new Solana instrument system utilizing Helicase Dependent Amplification (HDA). We will cover AmpliVue® Trichomonas and Solana™ GAS extraction free assays compared to conventional methods. The workshop will also feature presentations of clinical data and study results from collaborators using Sofia® Influenza A+B and Sofia® RSV.

 

MRSA Surveillance Testing as an Elementof an Infection Control Program
Supported by Roche Diagnostics
Hilton, Coquina E
Boxed Lunch will be served.

Speaker:
Thomas J. Kirn MD, PhD; Assoc. Director, Clinical Microbiology, Dept. of Pathology and Laboratory Medicine, NorthShore University HealthSystem

Overview:
Based on the advances made in molecular testing, screening for Methicillin Resistant Staph Aureus has become easier. Dr. Kirn will discuss the experience at NorthShore Hospital in Chicago, Illinois and their decision to utilize a PCR based test for this type of screening.


MONDAY, 2:45PM–4:15PM

Part I Title: Cervical Cancer Screening at a Crossroads: Combining Molecular and Cytology Based Technologies to Provide a Solution for Future of Cervical Screening
Part II Title: How Tampa General Hospital and Other Hospitals Use the Unique Capabilities of the BD MAX System to Address Molecular Testing Needs
Supported by BD Diagnostics
Hilton, St. John’s
Refreshments will be served.

Cervical Cancer Screening at a Crossroads: Combining Molecular and Cytology Based Technologies to Provide a Solution for Future of Cervical Screening

Speaker:
Jesper Bonde, PhD, Dipl. Med. Sci.; Senior Researcher Molecular Pathology Laboratory Dept Pathology/Clinical Research Centre, Copenhagen University Hospital, Hvidovre

Overview:
The current cervical cytology screening program stands to be challenged and the role of cytology will change. The four principal challenges driving the change from cytology to molecular HPV testing are:
• The well-established superior sensitivity for >CIN2 of molecular HPV DNA testing compared to cytology
• The introduction of HPV vaccinated women in cervical screening requires adaptation, as vaccinated birth cohorts will substantially decrease cytology sensitivity Risk stratification by molecular HPV technologies will re-focus efforts on women at risk, individualizing general population screening
• The ability to offer HPV testing from self-collected samples to women not otherwise participating in cervical cancer screening

Dr. Bonde will review the potential changes and implementation of HPV testing in the organized general population-based cervical cancer screening program in Denmark, combining HR-HPV testing with HPV genotyping, liquid based cytology, and HPV sample self-collection. All of these elements will be necessary to form a consolidated, effective cervical cancer screening solution for the future.  Dr. Bonde will also present the newest data from Europe using the BD Onclarity™ HPV Assay* to benchmark analytical and clinical performance against existing methods. Moreover, since 80% of all liquid based cytology samples in Denmark are taken in the BD SurePath™ liquid based cytology media, the presentation will focus on the performance of the BD Onclarity HPV Assay when testing specimens collected in BD SurePath. The presentation will also discuss the important differences in absolute risk of individual genotypes for detection of >CIN2, and why Dr. Bonde sees genotyping as an important consideration for integration into the future of Denmark’s cervical cancer screening program. Finally, the presentation provides a first look at the Danish program which introduces HPV testing of self-collected vaginal samples, a new testing scheme intended to increase participation in cervical cancer screening by reaching out to women not currently being screened.* The BD Onclarity HPV Assay is CE-marked in the EU; however, this product is not approved for clinical diagnostic use in the United States and several other global markets. Contact your local sales representative for availability.


How Tampa General Hospital and Other Hospitals Use the Unique Capabilities of the BD MAX System to Address Molecular Testing Needs

Speaker:
Suzane Silbert, PhD; Clinical Scientist, Esoteric TestingLab/Pathology Department, Tampa General Hospital

Overview:
Performance of BD MAX GBS using direct ESwab collected sample vs LIM broth enrichment medium. Performance of Different Laboratory Developed Tests onthe BD MAX Open System, including:
• HSV and VZV,
• Atypical Pneumonia,
• Enterovirus and Parechovirus,
• and more


Improving Global Health: Development of Xpert® Ebola and HIV Assays
Supported by Cepheid
Hilton, Tomoka AB
Refreshments will be served.

Overview:
In today’s global environment, infectious diseases and global outbreaks impact how we practice medicine in the United States. The right technology can outperform future needs to impact how laboratories, clinicians, and hospitals provide improved patient care while improving operations. This workshop will provide insights into how GeneXpert® can provide critical information with a single test, eliminating the need for time-consuming follow up testing to complete a diagnosis or provide expanded access to monitoring for vulnerable populations. During this session, a preview of the Xpert® Ebola EUA test and Xpert® HIV-1 Viral Load and Xpert® HIV-1 Qual assays (IUO) will be presented.

 


Focus Diagnostics Sample-to-Answer Testing for Group A Strep and HSV 1&2 with Simplexa™ Direct Kits
Supported by Focus Diagnostics
Hilton, Coquina GH
Refreshments will be served.

Evaluation of Simplexa™ HSV 1 & 2 Direct for the Detection of Herpes Simplex Virus Directly from CSF

Speaker:
Matthew Binnicker, PhD; Director, Clinical Virology, Department of Laboratory Medicine and Pathology, Mayo Clinic

This workshop will discuss laboratory testing for herpes simplex virus types 1 & 2, focusing on central nervous system infections. Experience comparing high complexity testing to moderate complexity testing with Simplexa™ HSV 1 & 2 Direct will be presented, as well as special considerations in the neonate.

Advances in Laboratory Detection of Group A Streptococci

Speaker:
Raymond Widen, PhD; Scientific Director, Esoteric Testing/R&D, Pathology Department, Tampa General Hospital

This workshop will discuss Group A Strep infection and current clinical test methodologies. A performance study of Simplexa Group A Strep Direct compared to culture will be presented together with other clinical validation study results.

 

Flexible Pricing and the Power of Verigene RP Flex
Supported by Nanosphere
Hilton, Flaggler
Beer and wine will be served.

Speakers:
Susan-Novak, PhD, D(ABMM); Direct of Microbiology, Southern California Kaiser Permanente Regional Reference Laboratory, North Hollywood, California.
Angela Silva, MT(ASCP); Microbiology Manager, St. Mary’s Hospital

Overview:
This workshop will feature two expert presentations covering the current budgetary and logistical dilemma that has accompanied the emergence of highly multiplexed molecular panels in the area of clinical microbiology, along with potential solutions to the problem. Nanosphere has introduced a novel flexible pricing concept that aims to bring multiplex panels out of the “one size fits all” era, enabling the selection, reporting, and purchase of only the desired targets for each sample from a broad syndromic panel. Presentations will address the need for such an approach along with commentary on real world experience with Verigene RP Flex — the first ever multiplex panel to incorporate flexible pricing.

 

chemagen Technology: Automated DNA/RNA Isolation
for Viral Applications
Supported by Perkin Elmer
Hilton, Ponce de Leon
Refreshments will be served.

Speaker:
Agnes Lichanska, PhD; Field Applications Scientist, PerkinElmer

Overview:
This tutorial aims to provide an overview of how chemagen technology can enable your research lab to do more with less. Many facilities performing high throughput nucleic acid isolations rely on several technologies and/or instruments to meet the needs of varying sample types and volumes. Following a brief overview of chemagen technology, we will go into how our solution can further improve your end results by facilitating greater viral nucleic acid recovery.


Changing the Paradigm of Infectious Disease with Molecular Testing
Supported by Roche Diagnostics
Hilton, Coquina E
Refreshments will be served.

How New Drugs And Diagnostic Tests Will Be Used To Win The Fight Against Chronic Hepatitis C: A Laboratorian’s View From The Trenches

Speaker:
Alexandra Valsamakis, MD, PhD; The Johns Hopkins Hospital

The landscape of HCV management continues to evolve rapidly as new direct-acting antivirals (DAAs) become available for the treatment of chronic hepatitis C (CHC) infection. HCV diagnostics have critical utility in the therapeutic management of CHC. This session will provide information on new highly effective DAA regimens, and how diagnostics will be used to tailor treatment selection, monitor therapy, and determine therapeutic response to DAAs.

Primary HPV Cervical Cancer Screening: Supporting Data and Guidance Updates

Speaker:
Julia Engstrom-Melnyk, PhD; Medical and Scientific Affairs, Roche Diagnostics

In 2014, the FDA approved the first hrHPV test for the use as a primary test for cervical cancer screening for women 25 years and older. More recently, interim guidance was co-published by the Society of Gynecologic Oncology (SGO) and the American Society for Colposcopy and Cervical Pathology (ASCCP) on the use of primary hrHPV testing as an alternative to current US cytology-based cervical screening methods as it was found to provide greater reassurance of low CIN3+ risk than a negative cytology result. Additionally, due to the high prevalence of CIN3+ in women 25–29, for which cytology— the current standard of care—detected fewer than 50% of these cases, primary HPV testing could be intiated as early as age 25. Primary hrHPV screening is a significant scientific and clinical advance in cervical cancer screening.

Advancing Molecular Diagnostics

Speaker:
Keith Earley, PhD; Roche Diagnostics

Based on advances in PCR testing Roche Molecular Diagnostics offers a new solution providing molecular results in as little as 20 minutes. This workshop will discuss the latest information on the advances in point-of-care molecular testing. There will be information about Influenza A/B and Group A Strep testing, in addition to the new cobas® Liat system.