Association for Molecular Pathology                       
Newsletter
October 2009, Volume 15, Number 3

Inside this Issue

Front Page
President's Message
Special Features
• AMP Advocacy
• AMP Test Directory
• CHAMP
• JMD Report
• Web Editorial Board
• AMP 2009 Preliminary Program
• AMP 2009 Corporate Workshops

• Announcements
Committee Reports
• Clinical Practice Committee
• Membership & Professional   
  Development Committee
• Nominating Committee
• Professional Relations
  Committee
• Program Committee
• Publications Committee
• Training & Education Committee
Subdivision Reports
• Genetics
• Hematopathology
• Infectious Diseases
• Solid Tumors
2009 AMP Officers and Appointees
AMP 2009 Annual Meeting & Exhibits
Corporate Workshops on Thursday, November 19, 2009

Abbott Molecular, Inc 1
The PLEX-ID Rapid Bioidentification System:  A Revolutionary New Tool for Global Surveillance

This symposium will highlight the newest addition to Abbott Molecular’s growing portfolio of molecular technologies for research use – the Research Use Only (RUO) PLEX-ID Rapid Bioidentification System. This technology, which is not cleared by the Food and Drug Administration for any clinical application, was developed to detect low-abundance and mixed infections, as well as identify new genetic variants without prior knowledge of viral sequence.  These features, combined with the ability to process hundreds of samples per day, would allow the system to monitor the evolution of infectious organisms during an outbreak.  The discussion will focus on the use of the RUO PLEX-ID Influenza Surveillance Kit for tracking the spread and evolution of influenza viruses.

Abbott Molecular, Inc 2
Advances in Flu and Other Respiratory Viral Testing
 
This session will focus on using the xTAG Respiratory Viral Panel for better decision-making in patient management and limiting the spread of infection. There will be discussions on its value in both clinical settings and as a surveillance tool. 

Abbott Molecular, Inc 3
The Abbott m2000 RealTime System: Improving Laboratory Workflow and Confidence in Result Reporting 
This session will focus on the description of the technology, assay design, m2000 menu and capabilities as well as results from external studies worldwide
 

Abbott Molecular, Inc 4
Primary Human Epidermal Growth Factor Receptor-2 (HER-2) Testing by Fluorescent In Situ Hybridization (FISH)
 
This session will focus on current testing guidelines for HER-2 with particular emphasis on biologic and methodologic considerations.

AcroMetrix
Innovative Molecular Technologies for Standardized Quality Control in Assay Development 
AcroMetrix will share exciting new technologies that can help IVD manufacturers accelerate product development and time to market through OEM opportunities. SynTura(TM) technology was developed to fill the need for high titer, stable, and reproducible material for calibration and quality control of RNA targets. The technology provides a cassette-based system whereby desired viral target sequences can be introduced into an intact RNA virus. These hybrid viruses are useful for the development of assay calibrators, external run controls, internal controls, and quantitation standards. This workshop will also present the design of a reproducible synthetic KRAS FFPE tissue control based on the ISO 17511 standard. The synthetic KRAS FFPE control can be adjusted with varying ratios of mutant to wildtype and total cell concentration per section. Compared to the limited number of KRAS sections from patient specimen blocks, a synthetic KRAS control allows for a limitless supply of reproducible material. 

Affymetrix, Inc
Advances in Array Based Molecular Diagnostics 
Affymetrix invites you to join us in a discussion on novel molecular diagnostic products and applications being developed utilizing the GeneChip platform.  Our Powered by Affymetrix speakers will focus on the clinical utility, workflow, clinical studies and validation, of their tests as well as sharing their experiences in novel array based molecular diagnostic test development.  Please join us to learn more about these exciting new products and applications using GeneChip technology.
 

Applied Biosystems
Essential Tools from Genetic Validation to Molecular Diagnostics 
DNA sequencing and fragment sizing applications using capillary electrophoresis are essential tools for discovering genetic variations for investigating disease conditions or researching susceptibility.  Applied Biosystems introduces the 3500 Series Genetic Analyzers, supporting the needs of process-controlled environments1.  Applied Biosystems also introduces the 7500 Fast Dx Real-Time PCR Instrument, delivering high-quality results in a flexible 96-well format.  Available for in vitro diagnostic use in the United States, the 7500 Fast Dx Instrument may support regulatory clearance for assays2. FOR RESEARCH USE ONLY. NOT FOR USE IN DIAGNOSTIC PROCEDURES.1For those who require IVD-marked devices, the 3500 Dx and 3500xL Dx Genetic Analyzers and system accessories meet the requirements of the In Vitro Diagnostic Medical Devices Directive (98/79/EC). The 3500 Dx and 3500xL Dx systems are for distribution and use in specific European countries only. For more information about the 3500 Dx Series Systems, contact your Applied Biosystems representative.2The customer is responsible for any validation of assay, and compliance with any regulatory requirements that pertain to their procedures and instrument use.The trademarks mentioned herein are the property of either Life Technologies Corporation, Applied Biosystems/MDS Analytical Technologies or otherwise, their respective owners. © 2009 Applied Biosystems LLC and MDS Inc. Joint Owners. All Rights Reserved. 

Asuragen, Inc 1
Molecular Approaches for Examing Neoplastic Disease in Solid Tumors, Including KRAS Mutations in Lung and Colon and Measuring miRNA Levels in Tissue. 
Asuragen, Inc. is a fully integrated diagnostic company dedicated to providing diagnostic solutions for molecular oncology and genetic testing.  Adding to our existing leukemia portfolio, Asuragen has recently launched our first mutliplex solid tumor assay, called Signature KRAS Mutations (RUO) for the detection of 7 somatic mutations in the kras oncogene.  This workshop will present preliminary data from the Signature KRAS Mutations assay on DNA extracted from both colon and lung FFPE samples.  We will also present updates on our CLIA  laboratory cancer miRNA tests.

Asuragen, Inc 2
Innovations in Fragile X and FMR1 Gene Testing
 
Asuragen, Inc. is a fully integrated diagnostic company dedicated to providing diagnostic solutions for molecular oncology and genetic testing.  This workshop will discuss groundbreaking new advances in Fragile X and FMR1 gene testing.
 

AutoGenomics, Inc
The Emergence of KRAS & BRAF Mutation Detection as a Critical Tool in Determining the Efficacy of anti-EGFR Therapy 
The integration of personalized medicine testing into clinical practice is now providing clinicians with the critical tools they require to assess the risks and benefits associated with the optimal prescribing of medications.  The most recent example has been the FDA’s re-labeling of Erbitux & Vectibix along with the recent guidelines from the American Society of Clinical Oncology and the National Comprehensive Cancer Network to include KRAS genetic testing prior to beginning anti- EGFR therapy.  This workshop will address the utility of KRAS & BRAF genetic testing and the clinical relevance for treatment of colorectal cancer patients with these mutations.
 

BD Diagnostic GeneOhm 1
Real-world Experience: C. difficile Testing With a Rapid Molecular Assay 
BD GeneOhm is the leader in molecular testing for MRSA, C. difficile and other pathogens that can cause HAIs. This year BD was the first to launch real-time PCR testing for toxigenic C. difficile. Learn about how this new assay will revolutionize patient care and infection control for C. difficile infection. Come hear real-world perspectives on how implementation of the BD GeneOhm™ Cdiff assay is making an impact by eliminating unnecessary re-testing, isolation, and inappropriate treatment while providing a higher standard of care.
 

BD Diagnostics GeneOhm 2 (with Handylab)
Redefining Molecular Testing in Medical Laboratories, a Molecular Revolution

In this workshop you will learn about Group B Streptococcus and Influenza assays on Jaguar as well as learning about HAI testing on the BD MAX™.  HandyLab and BD are working together to commercialize nucleic acid based assays for infectious diseases on the new Jaguar and BD MAX™ Systems, automated molecular diagnostic testing platforms.  The collaboration widely expands automated testing for infection testing programs in addition to numerous viral pathogens.  These systems provide greater flexibility and simplicity for molecular testing in medical laboratories.
 

Cambridge Research & Instrumentation, Inc
Multicolor Molecular Imaging and Automated Tissue Cytometry
 
Learn about unique new “intelligent” slide-analysis solutions from CRi, combining powerful multispectral capability with groundbreaking pattern-recognition image analysis. The Nuance™ system can be used to accurately separate overlapping signals, including autofluorescence, from samples stained with multiple fluorescent or immunohistochemical stains. Vectra™ is an automated high-throughput system that includes CRi’s inForm™ software, which uses a simple learn-by-example interface. It can differentiate relevant tissue regions (e.g. malignant and normal epithelia, stroma, and necrosis) and segment cellular compartments (e.g. nuclei, cytoplasm, and membrane), enabling detailed, spatially resolved multiparameter quantitation. Key biological questions about tissue composition or molecular phenotypical state can be answered, supporting a broad range of preclinical and clinical studies.
 

Cepheid, Inc
Advances in On-Demand Molecular Testing Using the GeneXpert System 
This workshop will focus on Cepheid’s GeneXpert® family of advanced molecular diagnostic systems, including the new GeneXpert Infinity–48 System. Discussions will be provided by industry representatives and will highlight newly introduced products like Xpert® C. difficile, including important technology advances that will drive Cepheid’s expanding menu of innovative Xpert tests. Additional presentations will highlight Cepheid’s newly formed HAI Consortium Initiative. 

Cleveland Clinic Reference Laboratory
Molecular Testing in Hematolymphoid Neoplasms: Using the 2008 WHO Classification 
In this educational session, Dr. James Cook will discuss molecular testing in routine hematopathology practice, with an emphasis on recent changes in the 2008 WHO classification of hematolymphoid neoplasms.  Topics to be covered include FLT3/NPM1 testing in acute myeloid leukemia (AML), FISH panels in myelodysplasia and AML, JAK2 V617F mutations and PDGFRA abnormalities in myeloproliferative neoplasms, clonality testing using BIOMED2 primers in non-Hodgkin lymphomas, and MYC translocations in Burkitt lymphoma and diffuse large B-cell lymphoma. Discussion will include the advantages and limitations of these techniques as well as important interpretive caveats. 

DxS with AltheaDx
Precision Medicine - Mutation Status and Therapeutic Response
 

Recent studies show patient responses to targeted therapies, such as anti-EGFR TKIs, are linked to gene mutations in cell signaling  pathways. KRAS mutations in colorectal cancer patients are strongly correlated with a lack of response to cetuximab and panitumumab. Conversely, the presence of EGFR mutations in NSCLC patients is associated with a favorable response to gefitinib and erlotinib. Consequently, there is increasing demand upon the molecular pathologist to provide mutation testing results from clinically validated qPCR assays, to guide therapeutic decisions. Individualising treatment choices for cancer patients fulfils the promise of practicing efficacious and cost effective precision medicine.

EraGen Biosciences
MultiCode®  Technologies: A Novel Approach to Molecular Testing in Infectious Diseases 
In this workshop, fellow leaders in clinical laboratory testing will present case studies that demonstrate the versatility and broad application of EraGen Biosciences’ innovative MultiCode® technology.   EraGen’s MultiCode®-RTx technology has the advantage of generating both qualitative and quantitative results on a wide variety of open platform real-time PCR instruments.  This workshop will demonstrate the ease-of-use of the MultiCode® technology and is important for clinical laboratories looking to expand their molecular testing capabilities.   

Focus Diagnostics
Focus & 3M System Introduction:  New Molecular Diagnostic Platform Validation in the 2009 H1N1 Flu Pandemic 
Focus Diagnostics and 3M will present their joint experience in developing a new molecular diagnostic system during the advent of the current 2009 H1N1 influenza pandemic. A panel of experts will present 1) an overview of the first commercial H1N1 reference laboratory testing and subsequent FDA emergency use authorization (EUA) of test kits, 2) PCR technologies chosen for implementing the testing service and evolution to test kit, and 3) the new Integrated Cycler from 3M and how it will change the way molecular testing is done in the laboratory. Join this lunch discussion about how a ‘perfect storm’ of product development and epidemic resulted in early release of a revolutionary molecular diagnostic system.  

Hologic, Inc
A Customer Experience Using the FDA Approved Cervista HPV Tests 
Hologic received approval for the Cervista HPV HR and Cervista HPV 16/18 tests in March of 2009.  Join us at our workshop to hear a customer experience with implementing the Cervista HPV tests and the positive impact these products have had on their laboratory and the physicians they serve.  In addition, Hologic will provide an update on our HPV automation program currently in development. 

Idaho Technology, Inc 1
The FilmArray: User Friendly MultiPlex PCR 
The FilmArray is user-friendly multiplex PCR.  This innovative system, by Idaho Technology, simplifies molecular testing through a completely automated protocol, beginning with integrated sample preparation and ending with automated analysis of results.  And it does it all in less than an hour with less than 5 minutes of hands-on time.  During this workshop we will perform a live demonstration of the FilmArray.  We will also introduce you to the FilmArray Respiratory Panel.  The FilmArray respiratory panel is a molecular diagnostic that detects 21 respiratory pathogens in less than an hour - including sample prep. Come see how easy molecular diagnostics can be. 

Idaho Technology, Inc 2
High Resolution Melting Applications in Infectious Diseases: HIV Sequence Diversity Assessment and Genotyping of Drug Resistant Malaria-causing P. falciparum Strains 
In the past, measuring diversity of the HIV virus in an infected person has been challenging at best.  We developed a novel LightScanner™ method based on Hi-Res Melting® peak shape to measure the viral diversity present in a patient sample.With nearly one million childhood deaths annually, malaria continues to defeat eradication efforts, primarily through increased resistance to common drug therapies. We designed LunaProbe™ assays to genotype several mutations in the P. falciparum genome that confer drug resistance. We also developed a method to enrich the mutant allele such that <1% can be detected with the LunaProbe.

iKaryos Diagnostics, Inc
SNP Array Karyotyping for Clinical Cancer Applications 
Chromosomal copy number alterations have been used to guide the management of cancer patients for decades, and there are many well-established, clinically validated applications for such techniques. In addition, cancer cells have a propensity to develop copy neutral loss-of-heterozygosity (LOH), which is not detectable by conventional karyotyping, array comparative genomic hybridization, or FISH. SNP array karyotyping provides dramatically better resolution than conventional karyotyping, does not require culture, performs well on paraffin-embedded samples, and readily detects copy neutral LOH, making it a powerful new addition to our molecular oncology tool box. Examples of the clinical impact of SNP array karyotyping will be presented and considerations for routine clinical use of the platform will be discussed.

Illumina, Inc 1
Using SNP Arrays to Identify Cytogenetic Aberrations 
As the adoption of SNP-based arrays continues to grow for rapid whole-genome cytogenetic analysis, new questions surface about workflow management and data analysis. In this session, attendees will hear from an expert panel about their experience addressing these issues and the results of their research using SNP-based arrays for comprehensive cytogenetic analysis. 

Illumina, Inc 2
Illumina’s BeadXpress System – An Array of Applications for the Molecular Laboratory 
The difference between good data and great data is in the code.  Illumina’s VeraCodeâ technology combined with the BeadXpressâ Reader delivers unparalleled data quality for a multitude of bioassays, including multiplexed genotyping, gene expression, methylation, and protein analysis.  In this session, attendees will learn about Illumina’s new ADME product and hear from experienced end-users about assay design and performance in their lab. 

Illumina, Inc 3
Advances in Next Generation Sequencing – Moving Basic Research to Clinical Diagnostics 
Next generation sequencing (or “Now’” generation sequencing) is rapidly changing the landscape of genetics, providing the ability to answer questions with unimaginable speed.  Continuing advancements will provide inexpensive, genome-wide data collection for a number of applications, including complex diseases such as cancer.  In this session, attendees will learn how Illumina is approaching translational medicine by utilizing the Genome Analyzer in its cancer initiative, and hear from early adopters of the technology. 

Ipsogen, Inc.
Independent Method Comparison for JAK2 V617F Detection at Henry Ford Hospital
A mutation in the JAK2 gene, V617F, has been identified in several BCR/ABL negative myeloproliferative neoplasms (MPN): polycythemia vera (95%), essential thrombocythemia (50%), and primary myelofibrosis (50%). Presence of V617F mutation is now part of clinical diagnostic algorithms, necessitating familiarity with available testing methods. In this workshop, Dr. Milena Cankovic will describe her laboratory’s independent evaluation of clinical performance of 3 screening methods and 1 quantitative method for JAK2 V617F detection. Screening for JAK2 mutations, measurement of allele burden, and possibly minimal residual disease monitoring, are all expected to play an increasingly important role in patient management.

Luminex Corporation
Luminex Diagnostic Assay - xTAG Respiratory Viral Panel and Cystic Fibrosis Kit 
Luminex Diagnostic Assays – Your Challenges, Our Solutions.  What we are doing to meet the needs of your lab, your physicians and your patients both today and into the future.  Workshop highlighting the Luminex xTAG assays - xTAG Respiratory Viral Panel and xTAG Cystic Fibrosis Kit.
 

Meridian Bioscience, Inc
Introduction to LAMP Technology and the illumigene Platform
Meridian Bioscience, Inc. has developed a high performing molecular assay for the detection of Clostridium difficile in stool samples utilizing Loop Mediated Isothermal Amplification (LAMP) technology. The illumigene™ assay provides a very simple testing procedure with low hands-on time and rapid time to results. The workshop will be an introduction to the illumigene™ assay including a discussion of LAMP technology, a demonstration of the assay process, an introduction to the illumipro-10™ instrument, as well as a discussion of the projected illumigene™ product pipeline.


Miltenyi Biotec, Inc
MACS® Technology for the Isolation of Lineage-specific Cells Directly from Whole Blood for Chimerism Analysis 
This workshop presents MACS® Technology for the isolation of cellular subsets from whole blood for downstream molecular analyses. The analysis of lineage-specific cellular subsets has been shown to be a powerful tool for the prediction of success of allogeneic bone marrow transplantation in chimerism monitoring.  Specifically, analysis of T cells allows for an early recognition of graft verses host disease verses malignant recurrence.  Combining the autoMACS™ Pro Separator with Whole Blood MicroBeads provides a highly efficient and reproducible method to isolate a variety of cellular subsets from whole blood with high purity. 

Nanosphere, Inc
Applications of Gold-Nanoparticle Technology for Medical Diagnostics 
Nanosphere, Inc. (Northbrook, IL, USA) has developed the Verigene® System, which is comprised of instrumentation and single use Verigene® Test Cartridges based on the company’s laboratory-proven, gold nanoparticle technology.  With the Verigene System, users can accomplish sensitive, accurate, and rapid multiplex detection of nucleic acid targets using enhanced signal-amplification techniques.  Several FDA-cleared tests (IVDs) are available for use on the Verigene System and others are in development.  This workshop will review both the currently available products and provide a preview of future offerings.

NanoString Technologies, Inc
NanoString’s nCounter Analysis System: A Highly Multiplexed Assay for Direct Detection of Nucleic Acid Molecules Using Color-Coded Molecular Barcodes 
We present a novel technology that captures and counts individual nucleic acid molecules.  The system is capable of measuring up to 500 different nucleic acid species in a single reaction without the need for enzymatic reactions or amplification.  The system is robust and flexible enough to measure a variety of input materials including formalin-fixed paraffin-embedded (FFPE) tissues, cell lysates, and blood.  The system has been used as a platform for measuring multi-gene diagnostic expression signatures and mRNA fusion-transcript biomarkers.  Current efforts to expand the platform to validate variations in genomic copy number will be presented.

NorDiag, Inc
Low Cost Automation for the Purification of Nucleic Acids from Stool and Urine, and a Novel Method of Detection of Bacterial and Yeast Infections in Blood

NorDiag is a manufacturer of automated nucleic acid sample preparation instruments designed for extraction from difficult sample matrices using magnetic beads.  NorDiag will be demonstrating their ARROW instrument with automated protocols for extraction and purification of nucleic acids from stool, urine and sputum.  NorDiag also distributes the Molzym reagents that are used for detection of pathogens in blood and culture.
 

Osmetech Molecular Diagnostics
The eSensor® XT-8 System: Warfarin Genetic Testing and the Significance of CYP4F2 and the eSensor® Respiratory Viral Panel

Recent literature has highlighted the benefit of pharmacogenetic guided dosing of warfarin for 46% of patients being initiated on warfarin with the clinical objective of reaching the stable therapeutic dose. An emerging genetic biomarker affecting warfarin dose is CYP4F2 which can account for an increase in warfarin dose of up to 1 1/2 mg /day. The eSensor® Respiratory Viral Panel is a 19 target multiplex test for respiratory viruses including swine flu with a sample to answer turn around time of less than 6 hours. Osmetech Molecular Diagnostics invites you to join us in reviewing assay validation and performance on the company's XT-8 instrument. The workshop will address the utility of both tests and how they can be easily performed on the XT-8. Warfarin Genetic Testing - role of CYP 4F2 and eSensor QIAGEN ResPlex II v2.0 respiratory viral panel. 

PreAnalytiX 1
Use of the PAXgene(R)  Blood RNA System and Source MDx Precision Profiles™ for Gene Expression Profiling in Subjects with Solid Tumors 
Source MDx, the leader in RNA-based molecular diagnostics, focuses on the development of diagnostic, prognostic, and predictive RNA biomarkers in whole blood that measure immune- and inflammation-related responses in cancer.  Using an integrated molecular diagnostic approach consisting of the PAXgene Blood RNA System with Source MDx Precision Profiles™, potential diagnostic, prognostic, and/or predictive biomarkers have been identified in nine solid tumor indications.  Data from studies of subjects diagnosed with various cancers and matched normal controls will be presented.
 

PreAnalytiX 2
The PAXgene(R) Tissue System:  Preservation of Morphology and Molecular Content in Human Tissue 
An integrated system for tissue fixation, stabilization, and nucleic acid purification has been developed by PreAnalytiX GmbH, a QIAGEN/BD company. The PAXgene Tissue System allows researchers to perform histochemical analysis as well as extraction of stabilized RNA, miRNA, and DNA from one sample.  Comparative data will be presented on histomorphology and DNA, RNA, and miRNA content in a variety of human normal and diseased tissues fixed in either the PAXgene Tissue System or formalin.  Results of histochemical, immunohistochemical, FISH, CISH, RT PCR, qRT PCR, PCR and qPCR analysis from paraffin embedded, PAXgene or formalin fixed tissue will be shown. 

Promega Corporation
The new Maxwell(R) 16 MDx System: A Better Way to Automate Extraction of 1 to 16 Viral Total Nucleic Acid Preps
Nucleic acid extraction continues to be an area where enhanced workflow provides improvements in molecular diagnostics lab productivity.   The new Maxwell® 16 MDx Instrument and Viral Total Nucleic Acid Extraction Kit provide reliable and consistent extraction from 1 to 16 plasma, serum or swab samples for use in amplification-based tests.   Integration of bar-code sample tracking and UV-light decontamination further enhance functionality of the Maxwell® 16 MDx Instrument.  This workshop will present the latest information on the new Maxwell® 16 System and user case studies relevant to molecular diagnostic labs who want to improve laboratory workflow in a cost-effective manner.
 

QIAGEN, Inc 1
HPV DNA Testing 
QIAGEN will present an educational seminar on the importance of HPV DNA testing and its role in managing cervical cancer risk.  For more than 8 years, the digene HPV HC2 DNA Test has been widely used as one of the tools for eradicating cervical cancer in women around the world. At this workshop, speakers will address the importance of HPV testing for patient care and the advantages of Hybrid Capture technology.  Speakers will also discuss the appropriate utility of HPV genotyping, and its role in cervical disease management according to current clinical guidelines.

QIAGEN, Inc 2
Pyrosequencing® Workflows in the Lab 
QIAGEN would like to invite you to this exciting talk on Pyrosequencing® technology.  Every day, laboratories are looking to increase efficiency and impact of day to day operations.  This talk will discuss the laboratory workflow from sample preparation through Pyrosequencing utilizing QIAGEN’s chemistries and automation platforms.  Automated systems such as the QIAcube or QIAsymphony are used for extraction, QIAgility for assay setup and a PyroMark system for analysis.  The presentation will focus on real world usage of the Pyrosequencing workflow in a clinical laboratory. 

QIAGEN, Inc 3
Advances in the Automation of HPV Testing
 

As the demand for HPV testing continues to increase, so does the need for highly automated solutions to process these test requests. In particular, liquid based cytology (LBC) samples are a particularly labor intensive sample type. QIAGEN is pleased to introduce the QIAensemble SP which provides a totally automated solution for the extraction of DNA from LBC samples. In addition, QIAGEN will introduce the HC 400 and the HC 2000 instruments that have the capacity to process up to 2,000 HPV results in an eight hour shift. These high throughput platforms have the ability to offer a broad menu of assays utilizing a unique detection technology.

Roche Applied Science
New Sequencing Technologies for Discovery in the Clinical Research Market 
The Genome Sequencer System was the first next generation sequencing platform on the market to challenge the traditional Sanger based technologies. Since its introduction four years ago, the system has enabled over 500 peer reviewed publications in applications ranging from amplicon resequencing for the identification of HIV quasispecies to detect rare drug-resistant somatic mutations and the identification of mutations involved in carcinogenesis, to the sequencing of whole human genomes. At AMP 2008, we presented novel sequencing assays to characterize and generate high resolution genotype information for HLA. At AMP 2009, we will introduce new technologies that expand upon the GS FLX Titanium series 400 to 500 base-pair sequencing read lengths. These advancements include improved amplicon sequencing strategies, sequencing read lengths that approach 1000 base pairs, full length cDNA sequencing, and more. 

Roche Diagnostics Corporation
Roche Diagnostics Corporation: Molecular Solutions for Improved Patient Care 
Roche Diagnostics is a leader in molecular diagnostics that delivers a wide range of products for the clinical laboratory.  Roche invites you to actively participate during our interactive symposium where experts will provide updates on topics such as HIV viral load testing, health-care associated infection screening, K-RAS mutation testing, and the new cobas 4800 system* currently in development.  You will contribute by providing insight based on your expertise in laboratory and clinical diagnostics with molecular methods.  Roche Diagnostics’ solutions are designed to bring innovation to laboratories that improve both patient care and laboratory excellence.*The cobas 4800 system is currently in development and not available for sale in the United States. 

SABiosciences Corporation
High Sensitivity and High-fidelity Gene Expression Analysis on FFPE Samples- A Technical Guide Workshop 
Paraffin-embedded tissues have been challenging for gene expression based molecular pathology analysis, largely due to the extensive RNA crosslinking and fragmentation.  We have thoroughly examined and optimized all steps in gene expression analysis for paraffin embedded tissues.  In this workshop, we will report the optimized protocols as well as the alternative methodologies we explored.  RNA extraction method, reverse transcription, transcript amplification, PCR primer design strategies will be presented in this comprehensive workshop on paraffin embedded tissues.  We will introduce FFPE PreAMP and RT2 PCR Array as the solution for real-time PCR based analysis using paraffin embedded tissues.
 

Sequenom, Inc
High-throughput Oncogene Mutation Profiling of Solid Tumors

Sequenom's mass spectrometry based method for nucleic acid analysis, MassARRAY, is now considered to be the technology of choice for the accurate and sensitive mutational analysis of heterogeneous tumor samples. In this session, attendees will hear how Drs. Chris Corless from OHSU and Marc Ladanyi from MSKCC, have developed and applied quantitative mutation panels for MassARRAY to interrogate multiple oncogene mutations simultaneously to guide cancer classification and rational therapeutic intervention.

SeraCare Life Sciences
Evaluating your New Test Methods: It’s NOT a Regulatory Exercise! 
When SeraCare presented this workshop in 2007, more than 80 of you attended, and your positive feedback has prompted us to update the information and the examples and offer it again.You need to know the strengths and weaknesses of your new test, to set up your QC program, and minimize nasty surprises.  CLIA requires you to verify its performance. So why not kill two birds with one stone? Using real-world examples, we’ll talk about how to manage risks, organize a real quality control program, increase your confidence in your test methods, and deliver accurate results. 

Siemens HealthCare Diagnostics
VERSANT® kPCR Sample Prep: Development of a Versatile, Fully-automated System for the Isolation of Nucleic Acids from Clinical Samples 
The VERSANT® kPCR Sample Prep system is a fully-automated platform developed for high yield and purity isolations of nucleic acids from a variety of clinical sample types. Purity and yield of nucleic acids are a prerequisite for optimized performance of all target-amplification based technologies used in the molecular diagnostic arena. The Siemens’ technology utilizes highly uniform micro magnetic particles (0.1 µm) coated with a nanolayer of silica. The homogenous beads allow excellent reproducibility, nucleic acid capture efficiency, and overall assay performance. This innovative technology provides for the time efficient and labor saving processing of large numbers of samples. The universal DNA and RNA extraction protocol has been developed to meet current as well as future molecular diagnostic testing needs from a variety of sample matrices ranging from liquids (e.g. serum, swabs) to tissue (e.g. formalin-fixed, paraffin embedded tissue sections). 

Signature Genomic Laboratories, LLC
New Advancements in Cancer Diagnostics by Microarray 
This workshop will describe new developments in array technology as they apply to the diagnosis of malignancies.  Novel improvements in array designs and techniques with the specific purpose of identifying all possible genomic rearrangements in cancer will be illustrated.  The significant contribution of these technologies to the workup of patients with hematological malignancies will be demonstrated.  In addition, the contribution of detecting unsuspected genomic rearrangements to disease classification and possibly treatment and prognosis will be discussed.

SmartGene, Inc
Sequence-based Identification of Bacteria and Fungi: A Clinically Valuable, Technically Feasible and Economically Appealing Approach
Sequencing is a useful tool for the rapid and precise identification of challenging pathogens. However, many laboratories are reluctant to implement this capability due to technical and economic concerns. At this workshop, experts from two leading clinical laboratories will describe their experiences in performing sequence-based identification of pathogens in a routine clinical setting, with particular emphasis on the management, analysis and interpretation of sequence data. The session will also report on the reimbursement level established by CMS for 2010 for the new CPT code "Culture, typing; identification by nucleic acid sequencing method, each isolate". Finally, a novel approach for the creation and updating of comprehensive reference sequence databases will be presented.