N O V E M B E R 1 5 , 2017

CORPORATEWORKSHOP DAY PROGRAM

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AMP 2017 Corporate Workshop DayHost Companies

WELCOME TO AMP 2017 WORKSHOP DAY!

Abbott Molecular*

Adaptive Biotechnologies Corp.

Agena Bioscience, Inc.

Agilent Technologies

Applied BioCode

Applied Spectral Imaging

ArcherDx

AstraZeneca*

Asuragen*

ATCC

Biocartis

BioFire Diagnostics, LLC

Biolyph

Bio-Rad Laboratories

Bristol-Myers Squibb

Clinical Genomics

DiaSorin Molecular

Fabric Genomics, Inc.

Fluidigm Corp

GenePOC

GenMark Diagnostics

GENOMENON

GenomOncology

Hologic*

Horizon Discovery LTD

HTG Molecular

iCubate

Illumina, Inc.*

IncellDx, Inc.

InteGen LLC

Integrated DNA Technologies

Invivoscribe Technologies, Inc.*

Luminex Corporation*

Menarini Silicon Biosystems

NanoString Technologies*

New England Biolabs

N-of-One Inc

Oracle Health Sciences

Oxford Gene Technology

PerkinElmer

PierianDx

Philips Healthcare

Promega Corporation

Q2 Solutions

QIAGEN*

Quidel Corporation

Qvella Corporation

Roche*

SeraCare Life Sciences, Inc.

STEMCELL Technologies, Inc.

Sunquest Information Systems

Swift Biosciences, Inc.

T2 Biosystems

Tecan

Thermo Fisher Scientific*

Vela Diagnostics*

*AMP Corporate Partner Company

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Notes

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AMP 2017 Corporate Workshop Day Schedule at a GlanceSTART END TITLE HOST ROOM

8:00 AM 8:50 AM Immune Repertoire and Clonality Identification on Your Own Terms ArcherDx 251A

8:00 AM 8:50 AMFrom Sequence to Clinical Report: Enabling Rapid Variant Analysis and Actionable Clinical Interpretation for Genomic Testing

Fabric Genomics, Inc. 255A

8:00 AM 8:50 AMNavigating Evidence with Judgment: Scaling Precision Medicine in the World of Evolving Guidelines

N-of-One Inc 250EF

8:00 AM 8:50 AM Research on New MSI Markers for Immunotherapy Response Promega Corporation 251D

8:00 AM 8:50 AM Preliminary Performance of Qvella’s FAST™ ID BSI Panel Qvella Corporation 250A

8:00 AM 8:50 AM Validate Your Clinical Genomics Assay Without Sacrificing Your Budget or Sanity

SeraCare Life Sciences, Inc. 251EF

8:00 AM 8:50 AM Innovations in Molecular Microbiology Roche 255BC

8:00 AM 8:50 AM Next Generation Sequencing in NSCLC Biomarker Testing Thermo Fisher Scientific 355BC

9:00 AM

9:00 AM 9:50 AMIntroducing Idylla™ – A Revolutionary Fully-Auto-mated System that Makes Molecular Diagnostics Convenient and Affordable

Biocartis 355A

9:00 AM 9:50 AMImprove Workflow Efficiency With Advanta NGS Library Prep Assays for Oncology and Inherited Genomics Using The Automated Juno System

Fluidigm Corp 251BC

9:00 AM 9:50 AM Molecular Subtyping using HTG EdgeSeq Gene Expression Profiling Assays HTG Molecular 250C

9:00 AM 9:50 AMUnderstanding the Heterogeneity, Dynamics and Spatial Interactions in Checkpoint Blockade Immunotherapy

NanoString Technologies 250D

9:00 AM 9:50 AMModular Automation Workflows for Maxwell® Nucleic Acid Extraction of Molecular Oncology Sample Types Such as ccfDNA from Plasma

Promega Corporation 251D

9:00 AM 9:50 AMA Molecular Pathology Lab’s Experience using NGS Panels & QCI™ Interpret for Variant Interpretation and Reporting Using AMP Guidelines

QIAGEN 253B

9:00 AM 9:50 AM Quidel Molecular Solutions Quidel Corporation 253A

9:00 AM 9:50 AM Increasing Automation and Improving Flexibility for Laboratory Developed Testing Roche 255BC

9:00 AM 9:50 AMThe T2Sepsis Solution: The Impact of Direct from Whole Blood Diagnostics in the Detection of Bloodstream Infections

T2 Biosystems 355D

9:00 AM 9:50 AM New and Innovative Approaches to Panel-Based Pathogen Detection – From UTIs to Respiratory Thermo Fisher Scientific 355BC

4

AMP 2017 Corporate Workshop Day Schedule at a GlanceSTART END TITLE HOST ROOM

10:00 AM

10:00 AM 10:50 AMRe-thinking FISH: New Developments in Multiplex FISH Applications

Abbott Molecular 251EF

10:00 AM 10:50 AM Digital MDx 3000: An Efficient, Automated Solution for Highly Multiplexed Syndromic Panel Tests Applied BioCode 250A

10:00 AM 10:50 AM AML Mutation Detection Using Error-Corrected Sequencing ArcherDx 251A

10:00 AM 10:50 AMPower the Revolution in Tissue Pathology with High-Parameter Immunohistochemistry Using Imaging Mass Cytometry

Fluidigm Corp 251BC

10:00 AM 10:50 AMCompanion Diagnostics, Targeted NGS Assays, and Gene Panels for Stratification and Monitoring of Hematologic Malignancies

Invivoscribe Technologies, Inc. 255D

10:00 AM 10:50 AM Less Is More: How Platform Consolidation Helps Patients, Providers, and Lab Professionals Luminex Corporation 255A

10:00 AM 10:50 AM Advancing Translational Research Through Digital Detection of RNA Signatures

NanoString Technologies 250D

10:00 AM 10:50 AMMaximizing NGS Library Prep: Enhanced DNA Quantitation, QC, and Size-Selection for Downstream Success

Promega Corporation 251D

10:00 AM 10:50 AM GeneReader QIAGEN 253B

10:00 AM 10:50 AMExpanding the Scientific Body of Knowledge with the New BRAF/NRAS Mutation Test and KRAS Mutation Test v2 for Life Science Research (LSR)

Roche 255BC

10:00 AM 10:50 AM Latest Innovations and Case Studies in NGS-Based Solid Tumor Profiling and Liquid Biopsy Research Thermo Fisher Scientific 355BC

11:00 AM

11:00 AM 11:50 AM Microbiome Standards for Next-Generation Sequencing ATCC 250C

11:00 AM 11:50 AM

A “Liquid Biopsy” Test Based on Detection of Two Epigenetically Modified Genes, BCAT1 and IKZF1 (Colvera), Identifies Circulating Tumor DNA (ctDNA) as a Marker of Recurrence in Colorectal Cancer (CRC) Patients

Clinical Genomics 253A

11:00 AM 11:50 AM Achieving Precision Medicine Through a Sample-to-Result, Cell-Based Liquid Biopsy Workflow

Menarini Silicon Biosystems 355D

11:00 AM 11:50 AM Bring Your Assay to Light Promega Corporation 251D

11:00 AM 11:50 AMLeading the Liquid Biopsy Revolution: Case Example of an Operational Genomics Workflow in a Molecular Pathology Lab

QIAGEN 253B

11:00 AM 11:50 AM NGS and Circulating Tumor DNA: Challenges and Opportunities Roche 255BC

11:00 AM 11:50 AM Introducing the SeqStudio Genetic Analyzer: Expert Results Simplified Thermo Fisher Scientific 355BC

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AMP 2017 Corporate Workshop Day Schedule at a GlanceSTART END TITLE HOST ROOM

12:00 PM

12:00 PM 12:50 PM

Next-Generation Genotyping of Unstable DNA: Expanding AmplideX® PCR Technology Across Neurodegenerative and Neurodevelopmental Disorders

Asuragen 251A

12:00 PM 12:50 PM The FilmArray® Pneumonia Panel: Potential Impact on Antimicrobial Therapy BioFire Diagnostics, LLC 250A

12:00 PM 12:50 PM Panther Fusion® – Syndromic Respiratory Testing is Evolving Hologic 251EF

12:00 PM 12:50 PM A Lab’s Perspective from Evaluating the New AVENIO ctDNA Analysis Kits Roche 255BC

12:00 PM 12:50 PM From Wet Bench to Dry Lab, a Complete Lab IT Solution Enabling Precision Medicine

Sunquest Information Systems 255D

12:00 PM 12:50 PM Liquid Biopsy Sequencing as a Genomics Tool in Pathology Swift Biosciences, Inc. 251BC

12:00 PM 12:50 PM Emerging Trends in MDx Automation Tecan 250EF

12:00 PM 12:50 PM Advancing Precision Genomics for Research in the Areas of Inherited Disease and Reproductive Health Thermo Fisher Scientific 255A

12:00 PM 12:50 PM Automated ‘Sample to Report’ Solution for Clinical NGS Testing in Virology & Oncology Vela Diagnostics 250D

1:00 PM

1:00 PM 1:50 PMSensitive, Specific, Standardized: How NGS is Advancing MRD Assessment for Patients with Lymphoid Cancers

Adaptive Biotechnologies Corp. 251D

1:00 PM 1:50 PM Clinical Applications of Liquid Biopsy in the Molecular Analysis of ctDNA in Cancer Agena Bioscience, Inc. 252

1:00 PM 1:50 PM Moving Towards Clinically Actionable Liquid Biopsies with Droplet Digital™ PCR Bio-Rad Laboratories 253B

1:00 PM 1:50 PM Current and Emerging Biomarkers in Immuno-Oncology Bristol-Myers Squibb 250C

1:00 PM 1:50 PM Evolve your lab’s molecular diagnostic capabilities with Panther Fusion® Hologic 251EF

1:00 PM 1:50 PM Perspectives on Comprehensive Clinical Genomics: Innovating for Today and Tomorrow Illumina, Inc. 355BC

1:00 PM 1:50 PM

TissuePrepMAX® Universal Solid Tumor Single Cell Preparation System For Immuno-Oncology and Oncology Assays Using Flow Cytometry and CTC Platforms

IncellDx, Inc. 355A

1:00 PM 1:50 PM New NEBNext Methods to Enable Translational Genomics New England Biolabs 355D

1:00 PM 1:50 PM Rapid RBC Depletion for Increased Laboratory Throughput

STEMCELL Technologies, Inc. 253A

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AMP 2017 Corporate Workshop Day Schedule at a GlanceSTART END TITLE HOST ROOM

2:00 PM

2:00 PM 2:50 PM Implementation of Pharmacogenetic Testing: Best Practices and Common Pitfalls Agena Bioscience, Inc. 252

2:00 PM 2:50 PM Identifying Low-level Variants in Liquid Biopsies Using Targeted NGS ArcherDx 251A

2:00 PM 2:50 PM GenePOC: Bringing the Lab to the Patient - Molecular Diagnostics Made Easy GenePOC 250A

2:00 PM 2:50 PMMolecular Oncology Biomarker Reporting: From Tertiary Analysis and Annotation to EMR Integration, Data Warehousing and Analytics

GenomOncology 250D

2:00 PM 2:50 PM Tissue vs. Liquid Biopsy: A Panel Discussion on Tumor Profiling Options Illumina, Inc. 355BC

2:00 PM 2:50 PM Interphase Chromosome Profiling (ICP): Technology and Clinical Applications InteGen LLC 251BC

2:00 PM 2:50 PM Progress in Precision Cancer Medicine Through Next Generation Sequencing (NGS)

Integrated DNA Technologies 255A

2:00 PM 2:50 PMUsing LymphoTrack® NGS Clonality Assays to Identify TCR and Ig Clonality and Somatic Hypermutation

Invivoscribe Technologies, Inc. 255BC

2:00 PM 2:50 PM The Incredible Shrinking Payment: How to Keep Pace with Reimbursement Issues Luminex Corporation 255D

2:00 PM 2:50 PM Improved Targeted NGS Sequencing with the NEXTFLEX® Myeloid Amplicon Panel PerkinElmer 250EF

3:00 PM

3:00 PM 3:50 PM Advances in Research of Precision Oncology Agilent Technologies 251D

3:00 PM 3:50 PM Precision Medicine in Cancer--New Indications for BRCA Testing AstraZeneca 251EF

3:00 PM 3:50 PM

OPTIMIZED LYOPHILIZATION: Provide Your Customers with Molecular Diagnostic Assays with Years of Room Temperature Stability and Simplified User Experience

Biolyph 250C

3:00 PM 3:50 PM Reexamining the Prognostic Value of Bordetella Pertussis and Parapertussis Diagnosis DiaSorin Molecular 355A

3:00 PM 3:50 PM LymphoTrack®, Internationally-Standardized NGS Clonality Assays and Software for MRD Assessment

Invivoscribe Technologies, Inc. 255BC

3:00 PM 3:50 PMImproving Clinical Decision Support Through Improved Access to Multiple, Integrated Genomic and Clinical Data Sources

Oracle Health Sciences 253A

3:00 PM 3:50 PM Molecular Profiling for Mutations – Increasing Our Understanding with NGS and Arrays Oxford Gene Technology 355D

3:00 PM 3:50 PM Reaching the Summit: Architecting a Blueprint for Accelerating Precision Medicine PierianDx 253B

7

AMP 2017 Corporate Workshop Day Schedule at a GlanceSTART END TITLE HOST ROOM

4:00 PM

4:00 PM 4:50 PMDevelopment of Efficient and Cost Effective NGS Based TP53 Genotyping Using FFPE Solid Tumor Samples

Agilent Technologies 251D

4:00 PM 4:50 PM Digital Imaging as an Alternative to Traditional Microscopy for Fluorescence In Situ Hybridization

Applied Spectral Imaging 251BC

4:00 PM 4:50 PM Room Temperature Stable Reagents in Less than 3 Weeks Biolyph 250C

4:00 PM 4:50 PM ePlex Solutions: Designed for the Patient, Optimized for the Lab GenMark Diagnostics 252

4:00 PM 4:50 PM Creating Evidence-Based Gene Panels by Mining the Genomic Literature GENOMENON 255D

4:00 PM 4:50 PM Innovative Cell-Line Derived Reference Standards for the Validation of Oncology NGS Workflows Horizon Discovery LTD 250D

4:00 PM 4:50 PM Clinical Application of the iCubate Gram-Positive Cocci (iC-GPC) Assay iCubate 250A

4:00 PM 4:50 PM Advanced Genomics Solutions for SNP Genotyping and Sequencing-Based Early Cancer Detection

Integrated DNA Technologies 255A

4:00 PM 4:50 PMDriving Signaling Pathways for Novel Therapeutic Options – Opportunities for Implementation and Interpretation

Philips Healthcare 251A

4:00 PM 4:50 PM Latest Advances in Precision Oncology Insights Utilizing Illumina’s TruSite Tumor 170 Assay PierianDx 253B

4:00 PM 4:50 PM Expanding the Latest Testing in Immuno-Oncology to the Clinic Q2Solutions 250EF

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8:00 AM – 8:50 AM

Immune Repertoire and Clonality Identification on Your Own Terms

Room: 251A Time: 8:00 AM-8:50 AM Hosted by: ArcherDx

Immune repertoire (IR) characterization is a powerful approach to monitor disease, measure the adaptive immune response to disease, and develop vaccines and therapeutic interventions. IR characterization by next-generation sequencing (NGS) is often challenging and can require proprietary synthetic controls to account for differential amplification efficiency. In this workshop, Dr. Nathan Montgomery from the UNC School of Medicine and Dr. Alex Lazar from MD Anderson Cancer Center describe their ability to confidently identify clonality and characterize the IR using targeted NGS coupled with powerful, transparent bioinformatics.

From Sequence to Clinical Report: Enabling Rapid Variant Analysis and Actionable Clinical Interpretation for Genomic Testing

Room: 255A Time: 8:00 AM-8:50 AM Hosted by: Fabric Genomics, Inc.

Genomic testing is increasingly performed in many clinical settings, but is often bioinformatically inefficient, with pipelines cobbled together from several separate pieces of software. Fabric Genomics’ Enterprise solution is an end-to-end bioinformatic pipeline, from FASTQ files through to a clinically actionable test report, which is optimized for the analysis and reporting of both germline and somatic variants. Learn how Fabric Enterprise is enabling accelerated, accurate and actionable clinical interpretation and reporting of patient genetic information from panels, exomes, and genomes, and delivering the promise of personalized medicine.

Navigating Evidence with Judgment: Scaling Precision Medicine in the World of Evolving Guidelines

Room: 250EF Time: 8:00 AM-8:50 AM Hosted by: N-of-One Inc

Learn how large hospital systems and commercial laboratories are managing the ever-growing body of literature and data to communicate levels of evidence in the landscape of AMP guidelines. Please join our expert panel as they discuss the increasing complexity of molecular diagnostic test interpretation in oncology. Topics will include the need to understand the role of multi-variant analysis in the context of the disease and the adaptation of reports to the guideline framework published by AMP in late 2016.

Research on New MSI Markers for Immunotherapy Response

Room: 251D Time: 8:00 AM-8:50 AM Hosted by: Promega Corporation

In clinical research, MSI is a biomarker that is proving to be increasingly important in understanding the most effective treatment methods for various types of cancers. Presented by Dr. James R. Eshleman of Johns Hopkins University School of Medicine.

Preliminary Performance of Qvella’s FAST™ ID BSI Panel

Room: 250A Time: 8:00 AM-8:50 AM Hosted by: Qvella Corporation

At Qvella™ we are committed to redefining “rapid” testing for pathogen identification. Our FAST™ ID (Field Activated Sample Treatment) technology is designed for detection and identification of bacterial and fungal pathogens direct from whole blood in under an hour*. This workshop will present preliminary performance data of the FAST™ ID BSI Panel.

*For Investigational Use Only; the performance characteristics of this product have not been established. This product is not available for sale.

10

Innovations in Molecular Microbiology

Room: 255BC Time: 8:00 AM-8:50 AM Hosted by: Roche

Healthcare practice has been shifting from empirical treatment with follow-up testing for confirmation or correction, to getting the right treatment to patients the first time. The Microbiology laboratory has always been at the heart of providing clinicians with answers they need to treat patients. However, many of the technologies have been in use for over 60 years, and aren’t fast enough to meet new demands. Roche has been responding by developing novel technologies giving healthcare systems the potential to provide faster, actionable, near patient answers. Join us as we take you on a tour of exciting new innovations from Roche.

Validate Your Clinical Genomics Assay Without Sacrificing Your Budget or Sanity

Room: 251EF Time: 8:00 AM-8:50 AM Hosted by: SeraCare Life Sciences, Inc.

It’s more important than ever to establish performance standards for safer, more effective clinical genomics tests. But without clear guidelines, it’s difficult to compare performance and efficacy data – especially with the inherent limitations of traditional materials and methods. Learn from recognized clinical genomics experts how modern QC tools – purpose-built for NGS-based assays – accelerate validation for less money and greater confidence in results. We will present a practical guide to more effectively validate high-performance assays with best practices you can implement in your laboratory.

Next Generation Sequencing in NSCLC Biomarker Testing

Room: 355BC Time: 8:00 AM-8:50 AM Hosted by: Thermo Fisher Scientific

As the number of targeted therapies in NSCLC rapidly increases, simultaneous testing for multiple biomarkers is becoming progressively important to enable a timely diagnosis and start of treatment. With the Oncomine™ Dx Target Test, the first multiple biomarker CDx test approved by FDA for NSCLC testing, NGS has become a reality in daily patient testing. Another application of NGS technology, cfDNA testing from liquid biopsies is showing great promise in clinical research due to the ability to also detect multiple DNA and RNA based biomarkers. Cancer Genetics Inc. will share their experiences working with both applications.

9:00 AM – 9:50 AM

Introducing Idylla™ – A Revolutionary Fully-Automated System that Makes Molecular Diagnostics Convenient and Affordable

Room: 355A Time: 9:00 AM-9:50 AM Hosted by: Biocartis

Turnaround time remains a major issue in molecular biomarker testing. Current technologies are complex, require a lot of hands-on time and are often difficult to implement in the local laboratory. All of these factors significantly affect turnaround times extending the time until the result report becomes available.

Get firsthand perspectives about how testing turnaround time of biomarkers can affect treatment decisions in oncology. Hear about challenges that laboratories are facing today and learn how the fully-automated Idylla™ system can help improving turnaround times in virtually any lab. Finally join us for a Idylla™ live demonstration.

8:00 AM Continued

11

Improve Workflow Efficiency With Advanta NGS Library Prep Assays for Oncology and Inherited Genomics Using the Automated Juno System

Room: 251BC Time: 9:00 AM-9:50 AM Hosted by: Fluidigm Corp

Establishing scalable and efficient next-generation sequencing (NGS) workflows is essential to meet dynamic demands for sample throughput, turnaround time, and cost controls with fixed resources. Join us in this workshop and hear from presenters that have developed and implemented Advanta™ NGS library prep assays on the Juno™ system to achieve higher productivity and greater capacity across a number of areas. Hear firsthand perspectives on workflow implementation, standardizing assay analytical performance, and options for reporting. Members of organizations performing routine NGS-based assays are encouraged to attend.

Fluidigm products are for Research Use Only. Not for use in diagnostic procedures.

Molecular Subtyping using HTG EdgeSeq Gene Expression Profiling Assays

Room: 250C Time: 9:00 AM-9:50 AM Hosted by: HTG Molecular

Molecular subtyping using gene expression profiling is emerging as an integral part of precision medicine. The ability to classify tumors by the tissue of origin and oncogenic driver has led to improved drug development processes and more precisely targeted trial designs. While subtyping is routine in some the areas such as breast cancer, other areas, such as lung cancer and lymphoma are challenging due to the large number of relevant markers and limited biopsy tissue. Using a very small amount of sample, the HTG EdgeSeq system empowers molecular profiling with the ultimate goal of achieving better patient outcomes.

Understanding the Heterogeneity, Dynamics and Spatial Interactions in Checkpoint Blockade Immunotherapy

Room: 250D Time: 9:00 AM-9:50 AM Hosted by: NanoString Technologies

Immune checkpoint blockade has shown tremendous promise in patients with melanoma, however responses remain heterogeneous. Therefore, better biomarkers are needed to identify patients who will benefit from these forms of therapy. Here, we studied a cohort of metastatic melanoma patients treated with CTLA-4 or PD-1 blockade. We performed molecular, immune, and Digital Spatial Profiling in order to identify biomarkers of response and mechanisms of resistance to checkpoint blockade. Furthermore, we investigated the impact of tumor heterogeneity on differential responses to therapy in a subset of patients with synchronous melanoma metastases. These findings provide insights into differential responses to checkpoint blockade.,Immune checkpoint blockade has shown tremendous promise in patients with melanoma, however responses remain heterogeneous. Therefore, better biomarkers are needed to identify patients who will benefit from these forms of therapy. Here, we studied a cohort of metastatic melanoma patients treated with CTLA-4 or PD-1 blockade. We performed molecular, immune, and Digital Spatial Profiling in order to identify biomarkers of response and mechanisms of resistance to checkpoint blockade. Furthermore, we investigated the impact of tumor heterogeneity on differential responses to therapy in a subset of patients with synchronous melanoma metastases. These findings provide insights into differential responses to checkpoint blockade.

Modular Automation Workflows for Maxwell® Nucleic Acid Extraction of Molecular Oncology Sample Types Such as ccfDNA from Plasma

Room: 251D Time: 9:00 AM-9:50 AM Hosted by: Promega Corporation

Oncology research increasingly focuses on how individual genetics influences treatment outcomes. This shift has increased in the number of samples and molecular analyses necessary to characterize an individual’s genetic state. The increased demand for molecular testing has driven the need for higher throughput, automated nucleic acid extraction solutions for a wide variety of oncology-related samples types such as blood, FFPE and circulating cell-free DNA (ccfDNA). Here we present a new adaptive, modular workflow for higher throughput, automated nucleic acid extraction and post extraction sample preparation for a variety of oncology-related sample types including ccfDNA from human plasma.

9:00 AM Continued

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A Molecular Pathology Lab’s Experience using NGS Panels & QCI™ Interpret for Variant Interpretation and Reporting Using AMP Guidelines

Room: 253B Time: 9:00 AM-9:50 AM Hosted by: QIAGEN

Among the concerns of molecular pathology labs performing oncology research is the ability to validate and ensure high-quality, high-sensitivity NGS tests. Another concern is interpreting and reporting NGS tests using current, complete cancer genomics information. Given the rapidly changing cancer genomics landscape, new information can impact the therapeutic, diagnostic and prognostic significance of somatic sequence variants. Dr. Pessetto (University of Kansas Medical Center) will discuss how her lab has addressed these concerns with NGS panels designed to detect ultra-low frequency variants and QCI-Interpret software for interpreting and reporting variants in cancer as recommended by AMP/ASCO/CAP guidelines. Dr. Litzenburger will discuss scientific considerations in implementing these guidelines.

Quidel Molecular Solutions

Room: 253A Time: 9:00 AM-9:50 AM Hosted by: Quidel Corporation

Join us at our workshop to learn how Quidel is revolutionizing the way you test for Respiratory, C. Diff, Strep and HSV/VZV, and why having the ability to differentiate VZV is important.

Increasing Automation and Improving Flexibility for Laboratory Developed Testing

Room: 255BC Time: 9:00 AM-9:50 AM Hosted by: Roche

Laboratories continue to seek innovative approaches for introducing automation to their molecular workflow to support lab developed testing with streamlined and flexible options. As laboratory needs continue to evolve, automated sample handling, processing, amplification, and detection are capable of improving lab efficiency, reducing errors, providing workflow flexibility and increased quality. This presentation will explore the latest advancements in automation for laboratory developed protocols.

The T2Sepsis Solution: The Impact of Direct from Whole Blood Diagnostics in the Detection of Bloodstream Infections

Room: 355D Time: 9:00 AM-9:50 AM Hosted by: T2 Biosystems

Join leading experts as they share their experiences with the T2Sepsis SolutionTM, an approach that combines the best standard of care for the management of sepsis patients with the T2Candida® and T2Bacteria® Panels. Run on the T2Dx Instrument in 3 to 5 hours, these panels have an overall sensitivity and specificity exceeding 90%. Panelists will discuss how the use of T2Candida in their institutions delivers improvements in patient care and substantial economic savings. The session will close with a discussion of early experiences with the T2Bacteria Panel, currently available as CE-IVD in the EU and RUO only in the US.

9:00 AM Continued

13

New and Innovative Approaches to Panel-Based Pathogen Detection – From UTIs to Respiratory

Room: 355BC Time: 9:00 AM-9:50 AM Hosted by: Thermo Fisher Scientific

As research continues to identify pathogens contributing to respiratory and urogenital disease etiology, laboratories have the ongoing task of developing strategies to analyze and interrogate an ever-increasing number of informative and actionable targets; which leads to high test costs, increased sample turn times, and burdensome multiple-method approaches for test deployment.

Multiplexing technologies – like real-time PCR – provide a proven, flexible, cost-effective and rapid tool in the development of routine diagnostic tests for broad panel pathogen surveillance. In this workshop, we will present two new research projects looking at multi-pathogen real-time PCR pathogens and their potential future use in the clinical laboratory.

10:00 AM – 10:50 AM

Re-thinking FISH: New Developments in Multiplex FISH Applications

Room: 251EF Time: 10:00 AM-10:50 AM Hosted by: Abbott Molecular

An introduction to multiplex FISH technologies in clinical research applications.

Moderator: Kathryn Becker, Ph.D, Oncology and CDx Franchise Director, Abbott Molecular

Digital MDx 3000: An Efficient, Automated Solution for Highly Multiplexed Syndromic Panel Tests

Room: 250A Time: 10:00 AM-10:50 AM Hosted by: Applied BioCode

Applied BioCode designs, develops, manufactures, and commercializes multiplex testing products for the IVD market. Come learn about the BioCode MDx 3000 platform and how it provides a breakthrough system for multiplex detection of nucleic acids, based on Digital Barcoded Magnetic Bead (BMB) technology. This flexible and highly cost effective, efficient platform can produce syndromic panel results from 188 clinical samples in <8 hours with minimal hands-on time. The BioCode Gastrointestinal Pathogen Panel (GPP)* IVD product will report molecular results for identification of 18 pathogenic intestinal bacteria, viruses, and parasites. *Under Development.,Applied BioCode designs, develops, manufactures, and commercializes multiplex testing products for the IVD market. Come learn about the BioCode MDx 3000 platform and how it provides a breakthrough system for multiplex detection of nucleic acids, based on Digital Barcoded Magnetic Bead (BMB) technology. This flexible and highly cost effective, efficient platform can produce syndromic panel results from 188 clinical samples in <8 hours with minimal hands-on time. The BioCode Gastrointestinal Pathogen Panel (GPP)* IVD product will report molecular results for identification of 18 pathogenic intestinal bacteria, viruses, and parasites. *Under Development.

AML Mutation Detection Using Error-Corrected Sequencing

Room: 251A Time: 10:00 AM-10:50 AM Hosted by: ArcherDx

Acute myeloid leukemia (AML) is a clonally heterogeneous cancer where the landscape of mutations is highly variable between children and adults, involving complex chromosomal translocations, indels and single nucleotide variants (SNVs). Traditional molecular assays rely upon multiple platforms to identify mutations but generally lack quantitation of rare clones. Advances in sequencing-based methods enable comprehensive detection of gene fusions, SNVs, gene expression and internal tandem duplications. In this workshop, Todd Druley MD, PhD from Washington University describes his use of error-corrected sequencing coupled with powerful bioinformatics to detect rare clonal variants in adult and pediatric AML.

9:00 AM Continued

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Power the Revolution in Tissue Pathology with High-Parameter Immunohistochemistry Using Imaging Mass Cytometry

Room: 251BC Time: 10:00 AM-10:50 AM Hosted by: Fluidigm Corp

The future of tissue pathology requires higher parameter imaging that surpasses the capabilities of colorimetric or immunofluorescence methods used today. Imaging Mass Cytometry™ uses proven CyTOF® technology to achieve highly multiplexed protein detection on a single slide by separating signals from metal-tagged antibodies, instead of fluorophores, and at 1 Da resolution. Join us in this workshop and hear from presenters that are using Imaging Mass Cytometry to characterize microenvironments of FFPE and frozen tissue sections from precious pathology samples at subcellular resolution. Members of organizations performing immunohistochemistry are encouraged to attend. Fluidigm products are for Research Use Only.

Companion Diagnostics, Targeted NGS Assays, and Gene Panels for Stratification and Monitoring of Hematologic Malignancies

Room: 255D Time: 10:00 AM-10:50 AM Hosted by: Invivoscribe Technologies, Inc.

Invivoscribe’s clinical laboratories, LabPMM, will showcase services making personalized molecular medicine a reality for patients globally. This is dependent on standardized methods for patient stratification and the ability to evaluate therapeutic success before relapse. LabPMM offers the first FDA-approved CDx for AML, the LeukoStrat® CDx FLT3 Mutation Assay; and two comprehensive gene panels, MyAML™ & MyHeme™, that are coupled with MyInformatics™ to identify structural variants and fusions. Patients can additionally be monitored with several services: MyMRD™, which identifies at least one mutation in 90-95% of AMLs; and FLT3 or NPM1 MRD. These assays provide clinically actionable data to optimize treatments.

Less Is More: How Platform Consolidation Helps Patients, Providers, and Lab Professionals

Room: 255A Time: 10:00 AM-10:50 AM Hosted by: Luminex Corporation

Speakers:

Stefan Juretschko, PhD, D(ABMM), Senior Director, Division of Infectious Disease DiagnosticsNorthwell Health Laboratories, Lake Success, NY

Bijaya Dhakal, PhD, D(ABMM), Director, Molecular LaboratorySonic Reference Laboratory, Austin, Texas

Clinical lab operations can be streamlined by selecting fewer testing platforms that offer more flexibility. In this workshop, directors from an integrated health network and a reference lab will present results from their experience with the ARIES® System, a sample to answer platform that allows operators to run both IVDs and LDTs when using a Universal Assay Protocol. Presentation topics from Dr. Stefan Juretschko from Northwell Health Laboratories and Dr. Bijaya Dhakal from Sonic Reference Laboratory will include C. difficile, Bordetella, flu/RSV, and LDTs, among others, and will highlight the advantages of platform consolidation.

Advancing Translational Research Through Digital Detection of RNA Signatures

Room: 250D Time: 10:00 AM-10:50 AM Hosted by: NanoString Technologies

Digital detection of nucleic acids is rapidly empowering molecular characterization of challenging diseases such as cancer in ways not previously feasible. With its high specificity and reproducibility, the NanoString platform is capable of measuring RNA and DNA counts from highly degraded samples from small sample inputs for quantitation of features of interest. This session will explore how groups working to analyze blood-based mRNA signatures have utilized the nCounter® platform for development of assays for lung cancer and sarcoma.

10:00 AM Continued

15

Maximizing NGS Library Prep: Enhanced DNA Quantitation, QC, and Size-Selection for Downstream Success

Room: 251D Time: 10:00 AM-10:50 AM Hosted by: Promega Corporation

As NGS pushes the boundaries of mutation detection from sub-optimal samples, there is a need for better QC prior to downstream analysis. In addition, the ability to reduce sample loss and more precisely size-select libraries can enhance the probability of successful sequencing of limited, degraded, or potentially contaminated samples. New methods for FFPE and circulating cell-free DNA QC, quantitation, and library size-selection will be discussed in the context of research performed by our speakers, with relevant sequencing metrics and data presented. Presented by Dr. Julie Laliberte of Progenity and Rebecca Peterson of Myriad.

GeneReader

Room: 253B Time: 10:00 AM-10:50 AM Hosted by: QIAGEN

While NGS has proven to be a very useful tool in basic research, two major hurdles remain for its broad adoption in clinical research: lack of seamless workflow for routine use, and truly relevant content to sensitively and accurately detect actionable insights.

In this workshop, two customers will share their experiences using the GeneReader NGS System to address these issues. Dr. Bösl implemented a routine test in cancer research; Dr. Patócs identified a rare case of coexistent BRCA1 and RET germline mutations.

Expanding the Scientific Body of Knowledge with the New BRAF/NRAS Mutation Test and KRAS Mutation Test v2 for Life Science Research (LSR)

Room: 255BC Time: 10:00 AM-10:50 AM Hosted by: Roche

Join us for an overview of the new BRAF/NRAS Mutation Test Life Science Research (LSR) and KRAS Mutation Test v2 Life Science Research (LSR) for use with formalin-fixed, paraffin-embedded tissue (FFPET) or plasma samples. Learn how the design, workflow and analytical specifications of these new kits may help you further your research efforts. These kits are for life science research use only, not for use in diagnostic procedures.

Latest Innovations and Case Studies in NGS-Based Solid Tumor Profiling and Liquid Biopsy Research

Room: 355BC Time: 10:00 AM-10:50 AM Hosted by: Thermo Fisher Scientific

Advancements in NGS are progressing at a very rapid pace and in this workshop we will review the latest additions to the Ion Torrent™ menu of solid tumor profiling, immuno-oncology and liquid biopsy NGS research assays. These new Ion AmpliSeq™ and Oncomine™ panels further enable clinical researchers to take a precision-genomics driven approach to profiling cancer research samples with minimal sample input and a rapid turnaround time. We will also highlight some case studies to show how these assays have been implemented for research use.

10:00 AM Continued

16

11:00 AM – 11:50 AM

Microbiome Standards for Next-Generation Sequencing

Room: 250C Time: 11:00 AM-11:50 AM Hosted by: ATCC

The complexities involved in 16S rRNA & shotgun metagenomics-analysis methods pose challenges for microbiome research & result in the introduction of biases. One of the obstacles in assay-standardization is the availability of reference materials & analytical tools. To support this, we have developed mock microbial communities from fully sequenced & characterized ATCC strains, based on their phenotypic & genotypic attributes or relevance in disease-specific research. They mimic mixed metagenomics samples & offer a universal control for microbiome analyses & assay-development.

Dev Mittar, Ph.D., ATCC Lead Scientist

Liz Kerrigan, Director, ATCC Commercial Partnerships/Standards

Nick Greenfield, Founder & CEO, One Codex

A “Liquid Biopsy” Test Based on Detection of Two Epigenetically Modified Genes, BCAT1 and IKZF1 (Colvera), Identifies Circulating Tumor DNA (ctDNA) as a Marker of Recurrence in Colorectal Cancer (CRC) Patients

Room: 253A Time: 11:00 AM-11:50 AM Hosted by: Clinical Genomics

The Colvera blood test detects circulating tumor DNA (ctDNA) in CRC patients with high sensitivity regardless of mutation profile or clonal evolution. The test is based on real-time PCR targeting two genes, BCAT1 and IKZF1, that are ubiquitously methylated in CRC tissues. In blood, detection of methylated ctDNA correlates well to depth of primary tumor invasion (T stage). Methylated ctDNA disappears in 75% of patients post-surgery, with persistence associated with advanced pathologic features and residual tumor. Colvera is positive in over 90% of stage IV CRC cases and is being used to evaluate patients post treatment for recurrence.

Achieving Precision Medicine Through a Sample-to-Result, Cell-Based Liquid Biopsy Workflow

Room: 355D Time: 11:00 AM-11:50 AM Hosted by: Menarini Silicon Biosystems

Precision Medicine requires accurate predictive biomarker evaluation for therapy selection. We present results from the combination of commercially available technologies into a coherent workflow which can implement cell-based liquid biopsy with unparalleled precision, and automation. The workflow is based on CTC enrichment and enumeration using CellSearch® system, CTC isolation by DEPArray™, and downstream genetic analysis using best-in class Ampli1™ WGA and kits for NGS analysis using targeted panels for sequence variants (SNVs and indels) and focal copy number alterations (CNA), as well streamlined methods for genome-wide copy number profiling based Low-Pass whole genome sequencing. The availability of this workflow has profound implications across the board from biomarker discovery and translational research to implementation in clinical routine.

Speakers:

Mark Carle Connelly, PhDChief Industrial Operations and R&D Officer, US Menarini Silicon Biosystems, Inc.

Nicolo` Manaresi, PhDChief Scientific Officer Menarini Silicon Biosystems spa

17

Bring Your Assay to Light

Room: 251D Time: 11:00 AM-11:50 AM Hosted by: Promega Corporation

An introduction to luciferase technologies in clinical research applications. Presented by Melanie Dart, Senior Research Scientist, Promega Corporation.

Leading the Liquid Biopsy Revolution: Case Example of an Operational Genomics Workflow in a Molecular Pathology Lab

Room: 253B Time: 11:00 AM-11:50 AM Hosted by: QIAGEN

Analysis of circulating tumor DNA (ctDNA) has enormous potential in the field of oncology, with the promise of better detection and monitoring of disease, fewer invasive procedures and ultimately improved patient outcomes. This talk will focus on a molecular pathology lab’s experience in implementing a genomics workflow using liquid biopsy samples. We will address the importance of access to high-quality ctDNA and other building blocks of life (DNA, RNA, proteins) to drive meaningful downstream insights, and how QIAGEN’s solutions offer a complete, efficient and streamlined liquid biopsy workflow.

NGS and Circulating Tumor DNA: Challenges and Opportunities

Room: 255BC Time: 11:00 AM-11:50 AM Hosted by: Roche

The increasing adoption of next generation sequencing in liquid biopsy for clinical research is transforming oncology, yet challenges remain in the application of NGS to circulating tumor DNA (ctDNA). Traditional approaches to sample preparation, sequencing, and analysis are often inadequate to address the difficulties—such as low volume of ctDNA per blood draw, the small fraction that is tumor-derived, and differences in tumor-specific mutation patterns among research subjects. Dr. Klass will discuss these challenges, and how AVENIO ctDNA analysis assays can help researchers maximize the information output from a limited source by detecting all four mutation classes in a single workflow.

Introducing the SeqStudio Genetic Analyzer: Expert Results Simplified

Room: 355BC Time: 11:00 AM-11:50 AM Hosted by: Thermo Fisher Scientific

From the leader in genetic analysis instrumentation, the new Applied Biosystems™ SeqStudio™ Genetic Analyzer, is a low throughput, easy to use, and convenient benchtop system that delivers gold-standard Sanger sequencing technology and fragment analysis with just one click. With an innovative all-in-one cartridge that reduces set-up time from hours to minutes, expert results are now routine. Join this workshop to learn more about the SeqStudio Genetic Analyzer and how leading researchers are using it in their laboratories.

11:00 AM Continued

18

12:00 PM – 12:50 PM

Next-Generation Genotyping of Unstable DNA: Expanding AmplideX® PCR Technology Across Neurodegenerative and Neurodevelopmental Disorders

Room: 251A Time: 12:00 PM-12:50 PM Hosted by: Asuragen

1-Spkr: Thomas W. Prior, Ph.D., FACMG, Professor of Pathology & Neurology, Director of Molecular Pathology, The Ohio State University Wexner Medical Cntr 2-Spkr: Andrew Hadd, Ph.D., Director of Research and Development, Asuragen, Inc.

Structural variants & repeat sequences comprise half of the human genome and are hallmarks of many neurodegenerative & neurodevelopmental disorders. Repetitive DNA has long challenged conventional diagnostic approaches & stifled scientific and clinical research. In this workshop, we will demonstrate how AmplideX® technology can be expanded to new, easy-to-use assay kits to characterize repeat loci across the genome. We will review several complex gene sequences implicated in neurological disorders, the difficulties they present in the laboratory, and how Asuragen is making analyses of these genes easier than ever.

The FilmArray® Pneumonia Panel: Potential Impact on Antimicrobial Therapy

Room: 250A Time: 12:00 PM-12:50 PM Hosted by: BioFire Diagnostics, LLC

The complex microbiology of lower respiratory samples has, so far, thwarted attempts to develop broad molecular diagnostic panels in this area. This workshop will highlight the potential of the FilmArray Pneumonia Panel to address a substantial unmet clinical need. Come hear Dr. Bourzac and Dr. Buchan discuss the FilmArray Pneumonia Panel’s clinical program. Dr. Bourzac will detail the design and implementation of the prospective clinical trial, and Dr. Buchan, a Principal Investigator for The FilmArray Pneumonia Panel clinical trial, will present preliminary data from the trial related to hypothetical changes to antibiotic therapy.

Panther Fusion® – Syndromic Respiratory Testing is Evolving

Room: 251EF Time: 12:00 PM-12:50 PM Hosted by: Hologic

Dr. Amy Leber, Nationwide Childrens, and Dr. Rangaraj Selvarangan, Children’s Mercy Hospital, will share their experience with the Panther Fusion® System* and respiratory assays*. They will share preliminary performance data and workflow analysis of the Panther Fusion respiratory assays compared to other molecular IVD assays.

Discover how the fully automated, random access Panther Fusion system provides a novel, modular approach to syndromic testing for respiratory viruses.

*Product in development, not available for sale in the US.

A Lab’s Perspective from Evaluating the New AVENIO ctDNA Analysis Kits

Room: 255BC Time: 12:00 PM-12:50 PM Hosted by: Roche

The accessibility of liquid biopsy samples and power of next-generation sequencing are collectively enabling the quantification of cancer-specific genomic aberrations in ctDNA shed from solid tumors. Attendees of this workshop will hear about a lab’s evaluation of Roche’s new AVENIO ctDNA Analysis Kits.

19

From Wet Bench to Dry Lab, a Complete Lab IT Solution Enabling Precision Medicine

Room: 255D Time: 12:00 PM-12:50 PM Hosted by: Sunquest Information Systems

Bringing molecular and genetic testing to the clinical mainstream requires a streamlined and scalable IT platform that can handle many highly complex workflows and very large data sets in an efficient and predictable manner. Learn how MedCompGx uses Sunquest Mitogen™ to support their Clinical NGS lab from the wet bench to the dry lab. MedCompGx will address how they are combating industry challenges through one end-to-end solution, Sunquest Mitogen. Specifically, how they manage their wet bench work with inventory, sample and workflow management, but then seamlessly manage their genetic data and quickly generate a patient report for actionable clinical use.

Liquid Biopsy Sequencing as a Genomics Tool in Pathology

Room: 251BC Time: 12:00 PM-12:50 PM Hosted by: Swift Biosciences, Inc.

Join Swift Biosciences for an interactive, educational workshop to discuss the role of genomic sequencing in liquid biopsy analysis (cfDNA, CTCs). In this discussion, we’ll review experimental approaches, including whole genome to targeted disease gene panels. Also, we’ll share best practices, guidelines and metrics from sample preparation to data analysis to better facilitate standardization and inform new users on the important considerations before implementation.

Panelists:

Honey Reddy, PhD, The Jackson LaboratoryJohn Martignetti, MD, PhD, Icahn School of Medicine at Mount SinaiJianwei Che, PhD, M3 GenomicsSumitra Mohan, PhD, Cancer Research UK, University of Manchester

Emerging Trends in MDx Automation

Room: 250EF Time: 12:00 PM-12:50 PM Hosted by: Tecan

What are the emerging trends in Molecular Diagnostics automation? How do changing market requirements and trends in infectious diseases, blood screening, oncology and prenatal testing affect automation requirements? This presentation will discuss the key technologies that enable companies to meet these challenges. In addition a real-life example of an innovative technology applied to a clinical challenge will be presented.

Advancing Precision Genomics for Research in the Areas of Inherited Disease and Reproductive Health

Room: 255A Time: 12:00 PM-12:50 PM Hosted by: Thermo Fisher Scientific

This workshop will highlight Thermo Fisher Scientific’s genetic analysis solutions and workflows that help accelerate research in the areas of inherited disease and reproductive health.

Automated ‘Sample to Report’ Solution for Clinical NGS Testing in Virology & Oncology

Room: 250D Time: 12:00 PM-12:50 PM Hosted by: Vela Diagnostics

One of the challenges pathologists face is the need for an automated workflow from sample to report. Vela DX has addressed this through the development of the Sentosa® Workflow. Join us to learn more about innovations driving simplicity in molecular testing. Pamela Ward, PhD of the Keck School of Medicine at USC will discuss the use of the Sentosa® workflow for cell-free DNA analysis in Oncology applications. Melanie Mallory, M.S. from ARUP Laboratories will present benchmarking data using our Sentosa® HIV Genotyping & DRM NGS Workflow. Finally we’ll share news on advances streamlining your clinical research.

12:00 PM Continued

20

1:00 PM – 1:50 PM

Sensitive, Specific, Standardized: How NGS is Advancing MRD Assessment for Patients with Lymphoid Cancers

Room: 251D Time: 1:00 PM-1:50 PM Hosted by: Adaptive Biotechnologies Corp.

Emerging molecular assays powered by next-generation sequencing (NGS) are rapidly gaining clinical significance, requiring pathologists and clinicians to reassess previous approaches to diagnosis, staging, and patient management. NGS-based assessment of residual disease (MRD) has demonstrated relevance in the management of patients with lymphoid malignancies. The clonoSEQ Assay combines NGS with innovations in chemistry and bioinformatics to deliver uniquely standardized, specific, and sensitive measurements of MRD in leukemia, myeloma and lymphoma. Evaluating MRD at deep sensitivity (10e-6) has been demonstrated to be of prognostic significance, making clonoSEQ a valuable tool that can inform clinical decision-making throughout the course of patient care.

Clinical Applications of Liquid Biopsy in the Molecular Analysis of ctDNA in Cancer

Room: 252 Time: 1:00 PM-1:50 PM Hosted by: Agena Bioscience, Inc.

Learn from leading world experts about how liquid biopsy analyses can provide reliable information on the highly sensitive detection of clinically relevant oncology targets. In today’s clinical management landscape, considerable burden in placed on pathologists to generate genetic testing that requires highly sensitive, multiplexed, low cost assays for the detection of targeted mutations.Discover how the use of Liquid biopsies can be a powerful predictive tool, which could be instrumental for monitor patients for clinical management and personalized medicine.

Moving Towards Clinically Actionable Liquid Biopsies with Droplet Digital™ PCR

Room: 253B Time: 1:00 PM-1:50 PM Hosted by: Bio-Rad Laboratories

Laboratories around the world are using Droplet Digital PCR technology to detect and quantify actionable biomarkers in cell-free DNA. The platform brings rapid and economical results to the clinic as an alternative to traditional genetic analysis methods. Examples will be presented at the workshop.

Current and Emerging Biomarkers in Immuno-Oncology

Room: 250C Time: 1:00 PM-1:50 PM Hosted by: Bristol-Myers Squibb

Many biomarkers are being investigated to further our understanding of cancer biology and the intersection with the immune system. This research is driving exploration of the potential to predict response to cancer immunotherapy. At this symposium, we will explore the rapidly evolving field of biomarker research and the impact on testing practices. Join us to gain insight into current and emerging immuno-oncology biomarkers in conjunction with associated technological advancements.

Evolve Your Lab’s Molecular Diagnostic Capabilities with Panther Fusion®

Room: 251EF Time: 1:00 PM-1:50 PM Hosted by: Hologic

Evolve your laboratory’s capability for molecular testing with the addition of the full Panther Fusion® system* or add the Panther Fusion® module* to your existing Panther® system. The Panther Fusion system joins the flexibility of PCR with the power of TMA to give your lab multiple valuable chemistries on a single platform.

Learn about Open Access™ functionality and the potential to develop your own assays and protocols on the Panther Fusion® system.

*Product in development, not available for sale in the US.

21

Perspectives on Comprehensive Clinical Genomics: Innovating for Today and Tomorrow

Room: 355BC Time: 1:00 PM-1:50 PM Hosted by: Illumina, Inc.

Speakers: Garret Hampton, Ph.D., Executive Vice President, Clinical Genomics Group, Illumina, Inc. Michael R. Rossi, Ph.D., Division Director Molecular Oncology of Solid Tumors, Seama4 Genomics, Associate Professor, Icahn School of Medicine, Mount Sinai

TissuePrepMAX® Universal Solid Tumor Single Cell Preparation System For Immuno-Oncology and Oncology Assays Using Flow Cytometry and CTC Platforms

Room: 355A Time: 1:00 PM-1:50 PM Hosted by: IncellDx, Inc.

Invited speakers will discuss IncellDx’s OncoTect iO Assay (Single Cell PD-L1 quantification/TILs/cell cycle) clinical validation using the TissuePrepMAX® Universal Solid Tumor Single Cell Preparation System as well as the use of the OncoTect iO Assay on peripheral blood for the characterization of circulating tumor cells (CTCs). Additionally, the importance of the immune environment in tumor samples is becoming clear with the widespread use of immuno-oncology drugs. A deeper analysis of the immune environment using the OncoTect iO assay reagents in a 20-color, single tube tissue immune profiling assay on non-small cell lung cancer samples will be presented.

New NEBNext Methods to Enable Translational Genomics

Room: 355D Time: 1:00 PM-1:50 PM Hosted by: New England Biolabs

As translational research continues to render genomic data tractable for clinical applications, a key challenge is the ability to generate high-quality data from diminishing quantities and highly variable qualities of nucleic acids that are typical of clinical collections. In addition, the requirement for faster, more efficient workflows demonstrate a need for continual improvement of sample preparation reagents. Presented here are novel, high-performance, streamlined NEBNext products for next generation sequencing sample preparation that are compatible with picogram to microgram input amounts across a broad range of DNA and RNA quality to produce high-quality sequencing data.

1:00-1:20 pmWhat’s new from NEBNext: Product Updates Fiona Stewart Ph.D. Portfolio Manager, Next Generation Sequencing, New England Biolabs

1:20-1:50 pmTargeted Genomic Profiling using Custom NEBNext Direct PanelsJennifer Sims, Ph.D. Manager, Assay Development Translational Genomics, Q2 Solutions

Rapid RBC Depletion for Increased Laboratory Throughput

Room: 253A Time: 1:00 PM-1:50 PM Hosted by: STEMCELL Technologies, Inc.

Processing blood samples using lysis buffer, hetastarch sedimentation or density gradient centrifugation to obtain leukocytes are standard protocols in many clinical laboratories. However, these methods can be time consuming and difficult to automate. This workshop will focus on how the group at Greenwood Genetic Center has used the EasySep™ RBC Depletion Kit to obtain untouched leukocytes to ultimately assess the activity of lysosomal enzymes. The EasySep™ RBC Depletion Kit immunomagnetically depletes red blood cells (RBCs) without the need of lysis or centrifugation steps for rapid cell isolation. In addition, it can be automated using RoboSep™ to increase laboratory throughput.

1:00 PM Continued

22

2:00 PM – 2:50 PM

Implementation of Pharmacogenetic Testing: Best Practices and Common Pitfalls

Room: 252 Time: 2:00 PM-2:50 PM Hosted by: Agena Bioscience, Inc.

Assurex Health is a leading Pharmacogenetic testing provider whose GeneSight® test is estimated to have benefitted more than 500,000 people. Dr. Gunselman, Vice President of Laboratory Operations will share key considerations for creating and operating a pharmacogenetics testing facility; including clinical studies and technology selection.

Identifying Low-level Variants in Liquid Biopsies Using Targeted NGS

Room: 251A Time: 2:00 PM-2:50 PM Hosted by: ArcherDx

Liquid biopsies are less invasive and can add value beyond tissue biopsies in advanced solid tumor patients, but circulating tumor DNA (ctDNA) is typically highly fragmented and present in low abundance. NGS-based assays must be sensitive enough to detect low-level mutations (allele fraction <2%) from low input DNA (10-100ng). In this workshop, Dr. Margaret L. Gulley from the UNC School of Medicine and Dr. A. John Iafrate from Massachusetts General Hospital describe their ability to confidently detect variants in plasma DNA using targeted NGS coupled with powerful bioinformatics.

GenePOC: Bringing the Lab to the Patient - Molecular Diagnostics Made Easy

Room: 250A Time: 2:00 PM-2:50 PM Hosted by: GenePOC

The FDA-cleared revogene™ is an automated and standalone instrument. It enables testing of single-use proprietary microfluidic cartridges, or PIEs, with fluorescence-based real-time polymerase chain reaction platform to deliver an accurate diagnosis. With its fully integrated user interface and touchscreen, the revogene saves valuable space and is made easy to use by healthcare professionals. Join us for this industry workshop and learn from current revogene users about the ease of use, overall performance of GenePOC assays and what promising future it has for their lab.

Molecular Oncology Biomarker Reporting: From Tertiary Analysis and Annotation to EMR Integration, Data Warehousing and Analytics

Room: 250D Time: 2:00 PM-2:50 PM Hosted by: GenomOncology

Allison Cushman-Vokoun, MD, PhD, FCAP - Medical Director of the Molecular Diagnostics Laboratory and W. Scott Campbell, PhD, MBA - Assistant Professor, Health Informatics and Pathology Informatics, discuss how they use GenomOncology software to report and annotate variants from NGS oncology panels, and how they are developing a streamlined integrative approach involving the molecular pathology lab, computable terminology standards and data exchange. The goal of such an endeavor is to realize an end-to-end solution for tertiary analysis, reporting, data integration with the EMR (Epic), and mining clinical and molecular data to efficiently and effectively practice precision oncology.

Tissue vs. Liquid Biopsy: A Panel Discussion on Tumor Profiling Options

Room: 355BC Time: 2:00 PM-2:50 PM Hosted by: Illumina, Inc.

Moderator: John Leite, Ph.D., Vice President, Global Strategic Partnerships, Illumina, Inc.

23

Interphase Chromosome Profiling (ICP): Technology and Clinical Applications

Room: 251BC Time: 2:00 PM-2:50 PM Hosted by: InteGen LLC

InteGen LLC is a diagnostic reagent manufacturing company that has developed a disruptive technology called Interphase Chromosome Profiling (ICP). We are revolutionizing the way chromosomes are recognized, in both interphase and metaphase preparations. In this workshop, you will learn how to 1) obtain a molecular karyotype from uncultured POC material including the detection of Robertsonian translocations, 2) characterize the derivative chromosomes and identify “add” material, 3) provide a failure-proof result for all hematologic malignancies, 4) streamline Multiple Myeloma diagnostic work-ups in one to two steps, and 5) molecularly profile circulating tumor cells (CTC) from the peripheral blood i.e., “liquid biopsy”.

Progress in Precision Cancer Medicine Through Next Generation Sequencing (NGS)

Room: 255A Time: 2:00 PM-2:50 PM Hosted by: Integrated DNA Technologies

Precision medicine is driving the need for more sensitive clinical tools. At this workshop, researchers from pharmaceutical and academic medicine settings will share their experiences in 1) validating a custom NGS panel to assess inherited cancer risk in a high throughput CLIA laboratory and 2) implementing a precision medicine program using targeted NGS panels to match cancer patients to targeted-therapy clinical trials based on genomic alterations instead of tissue of origin.

Using LymphoTrack® NGS Clonality Assays to Identify TCR and Ig Clonality and Somatic Hypermutation

Room: 255BC Time: 2:00 PM-2:50 PM Hosted by: Invivoscribe Technologies, Inc.

Invivoscribe has developed LymphoTrack® (RUO) and LymphoTrack® Dx (CE-IVD) Assays for leading benchtop NGS sequencers. Kits are provided with bioinformatics that identifies clonality at the sequence level and determines the IGHV somatic hypermutation status, eliminating Sanger sequencing. Invited speakers will present case studies and validation data showing how the assays streamline workflow and reduce interpretation subjectivity. The new LymphoTrack TRB Assay will also be showcased with data demonstrating how simultaneous testing of TRG, TRB, IGH, and IGK reduces costs and turnaround time. Subsequent MRD testing using the same LymphoTrack reagents and workflow will be discussed in a workshop later today.

The Incredible Shrinking Payment: How to Keep Pace with Reimbursement Issues

Room: 255D Time: 2:00 PM-2:50 PM Hosted by: Luminex Corporation

Speakers:

Charles Mathews, MPP, Vice PresidentBoston Healthcare

Erin McElvania TeKippe, PhD, D(ABMM), Director of Clinical MicrobiologyNorthShore University Health System, Evanston, Illinois

Navigating the reimbursement landscape can feel like stepping into quicksand. In this session, a reimbursement specialist, Charles Mathews, Vice President at Boston HealthCare and a lab expert, Dr. Erin TeKippe, Director of Clinical Microbiology at Northshore University Health System, will update attendees on recent changes, ongoing challenges, and how to identify key issues for testing and payment. Real-world examples about respiratory testing and optimizing testing algorithms will be included to demonstrate best practices.

2:00 PM Continued

24

Improved Targeted NGS Sequencing with the NEXTFLEX® Myeloid Amplicon Panel

Room: 250EF Time: 2:00 PM-2:50 PM Hosted by: PerkinElmer

This workshop offers perspectives on the benefits of targeted sequencing of somatic variants in myeloid malignancies as a clinical research tool. The NEXTFLEX® Myeloid Amplicon Panel offers performance-verified results that boast full coverage of difficult GC-rich regions and robust uniformity of homopolymer sequences, low variants, and exons in SRSF2 and U2AF1 not covered by some panels. This solution also addresses common issues hampering routine molecular testing including shelf life, kit size, DNA input requirements, and workflow issues.

Join us to learn about the speaker’s experience using the NEXTFLEX® Myeloid Amplicon Panel as a cost-effective and comprehensive library preparation solution.

3:00 PM – 3:50 PM

Advances in Research of Precision Oncology

Room: 251D Time: 3:00 PM-3:50 PM Hosted by: Agilent Technologies

Presented by David Spetzler, MS, PhD, MBA

President and Chief Scientific Officer, Caris Life Sciences

For details and to reserve your spot: https://agilent.cvent.com/AMP

Precision Medicine in Cancer – New Indications for BRCA Testing

Room: 251EF Time: 3:00 PM-3:50 PM Hosted by: AstraZeneca

It has long been recognized that germline BRCA1 and BRCA2 mutations contribute significantly in risk of development of multiple cancer types. Recent studies have provided evidence of the prognostic value of knowing BRCA1/2 mutation status in women with ovarian cancer. Newly approved PARP inhibitors as a targeted therapy in patients with BRCA1/2 mutations has further expanded the clinical utility of BRCA testing. This workshop will provide an up-to-date overview of the predisposition, prognostic and predictive value of BRCA testing as well as timely and optimal testing pathways in clinical settings.

OPTIMIZED LYOPHILIZATION: Experience Molecular Diagnostic Assays with Years of Room Temperature Stability and Simplified User Experience

Room: 250C Time: 3:00 PM-3:50 PM Hosted by: Biolyph

BIOLYPH provides lyophilization services for PCR Master Mixes and other molecular diagnostic reagents for molecular diagnostic assay developers and manufacturers.

A single Master Mix LyoSphere™ can contain Enzymes, Oligonucleotides, Dyes, RNAse Inhibitors, Cations, dNTPs, Buffers and Excipients in a stable, consistent form, which rehydrates instantly and can be packaged into virtually any device format.

Timothy Pearcy, Founder and Managing Director of BIOLYPH, details BIOLYPH’s capabilities to provide lyophilized Master Mixes for molecular diagnostic assays that deliver simplified product storage and transport, higher product stability over broader temperature tolerances, longer product shelf-life, and superior end-user ease of use.

2:00 PM Continued

25

Reexamining the Prognostic Value of Bordetella Pertussis and Parapertussis Diagnosis

Room: 355A Time: 3:00 PM-3:50 PM Hosted by: DiaSorin Molecular

Karissa Culbreath, PhD D(ABMM)TricoreScientific Director – Infectious DiseaseAssistant Professor Department of Pathology

Whooping cough caused by Bordetella infection is resurging in recent years. Dr. Karrisa Culbreath from Tricore Reference Laboratories will discuss the clinical presentation of Bordetella infection and its public health impact, the diagnostic value of extracted versus direct amplification of B. pertussis and B. parapertussis, and the prognostic value of Bordetella diagnosis based on clinical presentation.

LymphoTrack®, Internationally-Standardized NGS Clonality Assays and Software for MRD Assessment

Room: 255BC Time: 3:00 PM-3:50 PM Hosted by: Invivoscribe Technologies, Inc.

Invivoscribe and collaborators will show how to easily identify and track B-and T-cell malignancies with the same LymphoTrack® reagents used for clonality and somatic hypermutation testing. LymphoTrack NGS methods offer better sensitivity than either ASO-PCR or multi-parameter flow cytometry using an approach that is already on its way to being standardized in laboratories worldwide in workflow, software, and interpretation. The same reagents can also assess and track CAR-T cells and other immunotherapies. Bioinformatics provided with kits facilitates automated data analysis. The wealth of information generated with LymphoTrack reagents provide actionable data and insights into the complexities surrounding MRD.

Improving Clinical Decision Support Through Improved Access to Multiple, Integrated Genomic and Clinical Data Sources

Room: 253A Time: 3:00 PM-3:50 PM Hosted by: Oracle Health Sciences

Clinical decision support is a rapidly evolving focus area in research and clinical practice. New data sources, technologies and workflows are being developed and refined to advance this field and improve patient outcomes, however challenges remain to scale and meet demand and greater patient numbers. We present a customer led discussion on the value and complexities of compiling data from multiple clinical and genomic sources for clinical decision support. A use case will be presented to demonstrate the advantages of developing a standardized data aggregation platform to support clinical and scientific staff in clinical decision support and reporting.

Molecular Profiling for Mutations – Increasing Our Understanding with NGS and Arrays

Room: 355D Time: 3:00 PM-3:50 PM Hosted by: Oxford Gene Technology

Two speakers lead this workshop to present how and why NGS or arrays were used in their molecular profiling workflows.

1) Molecular interrogation research using NGS in myeloproliferative neoplasm samples presented by Dr. Susan Hsiao, MD, PhD, Assistant Professor of Pathology and Cell Biology, Columbia University Medical Center and 2) Adopting CytoSure™ Constitutional v3 arrays in the laboratory: The OHSU experience presented by Dr. Stephen Moore, MBA, PhD, FACMG, Assistant Professor Molecular & Medical Genetics, OHSU.

In both cases, selected products from OGT provided accurate results, and rapidly developing software platforms yielded fast and simple evaluation of data.

3:00 PM Continued

26

Reaching the Summit: Architecting a Blueprint for Accelerating Precision Medicine

Room: 253B Time: 3:00 PM-3:50 PM Hosted by: PierianDx

Implementing a world-class Precision Medicine program is no easy task. It depends on a range of factors, including strategic planning, executive support, integration of genomic testing into care pathways, accessing genomic data within the electronic medical record, establishing the right testing portfolio, lab workflow optimization and more. In roundtable format, moderated by PierianDx’s Chief Informatics Officer Rakesh Nagarajan, leaders in Precision Medicine will discuss architecting their programs, challenges faced, and key factors for success. Common criteria among their programs will be discussed that enabled the full utilization of genomic testing for advancing precision medicine and creating better outcomes for patients.

4:00 PM – 4:50 PM

Development of Efficient and Cost Effective NGS Based TP53 Genotyping Using FFPE Solid Tumor Samples

Room: 251D Time: 4:00 PM-4:50 PM Hosted by: Agilent Technologies

Presented by Meenakshi Mehrotra, PhD

Postdoctoral Fellow and Bedia Barkoh, MD Anderson Cancer Center

For details and to reserve your spot: https://agilent.cvent.com/AMP

Digital Imaging as an Alternative to Traditional Microscopy for Fluorescence In Situ Hybridization

Room: 251BC Time: 4:00 PM-4:50 PM Hosted by: Applied Spectral Imaging

FISH testing in tissue diagnostics is growing rapidly, creating a need for updated workflows and computer-assisted technologies. Digital imaging and analysis systems significantly improve lab productivity, user experience and results accuracy.

Join us as we welcome Dr. Mohamed Salama, Chief of Hematopathology at ARUP Laboratories, who will share his experience of ASI’s novel solutions for tissue FISH. New data will be presented highlighting the clinical impact of these new digital workflows.

Room Temperature Stable Reagents in Less than 3 Weeks

Room: 250C Time: 4:00 PM-4:50 PM Hosted by: Biolyph

BIOLYPH has optimized the formulation, lyophilization parameters and stabilization for tens of thousands of reagents now enjoying many years of room temperature stability.

You will learn how BIOLYPH serves manufactures and reagent developers Efficiently, Effectively and Economically achieving the highest quality finished reagents possible.

Timothy Pearcy, Founder and Managing Director of BIOLYPH, has innovated lyophilization technology for 34 years.

3:00 PM Continued

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ePlex Solutions: Designed for the Patient, Optimized for the Lab

Room: 252 Time: 4:00 PM-4:50 PM Hosted by: GenMark Diagnostics

ePlex® offers unique solutions to address the most significant challenges facing clinical laboratories, while supporting hospital systems to deliver patient-centered, value-based care. Learn how ePlex streamlines the diagnostic workflow from physician order entry to the final test report, and is the only true sample-to-answer solution designed to improve patient care, reduce costs, and increase lab efficiency.

Creating Evidence-Based Gene Panels by Mining the Genomic Literature

Room: 255D Time: 4:00 PM-4:50 PM Hosted by: GENOMENON

Clinicians and researchers face a daunting challenge developing rational diagnostic panels for next-generation sequencing. Drs. Kiel and Weigman will present a method for evidence-based panel design used to select the content for an AML gene panel by mining millions of full text genomic articles to identify disease-gene-variant relationships through Mastermind®. By generating a comprehensive list of biomarker candidates associated with a specific disease in the scientific literature, an evidence-based gene panel was created in under a week with literature citations for each biomarker selected.

Innovative Cell-line Derived Reference Standards for the Validation of Oncology NGS Workflows

Room: 250D Time: 4:00 PM-4:50 PM Hosted by: Horizon Discovery LTD

Horizon Discovery offers high quality DNA and RNA reference standards for the reliable validation of NGS and dPCR assays. Based on our underlying gene editing technology, we can offer cell-line derived reference standards that are best-placed to represent challenging real-world oncology samples. Our extensive portfolio of over 400 diagnostic reference standards offers a variety of formats to suit a wide range of clinical workflows; including high molecular weight DNA, formalin-compromised DNA, FFPE curls, RNA, cfDNA, FISH and IHC. Come along and learn of the latest technological advances in our key focus areas of RNA, cfDNA and large oncology reference standards.

Clinical Application of the iCubate Gram-Positive Cocci (iC-GPC) Assay

Room: 250A Time: 4:00 PM-4:50 PM Hosted by: iCubate

Clinical Application of the iCubate Gram-Positive Cocci (iC-GPC) Assay

The iCubate “iC -GPC Assay™” is a FDA cleared, multiplexed, in vitro diagnostic test for the identification of potentially pathogenic bacteria and clinically significant resistance markers directly from a positive blood culture, to aid in the diagnosis of Blood Stream Infection. iCubate’s core technology, Amplicon Rescued Multiplex PCR (ARM- PCR), which detects multiple pathogens simultaneously, solves a variety of problems in the clinical laboratory. iCubate developed the iC-GPC Assay and coupled it with an easy to use, automated, closed system, meeting clinical laboratory needs and improving patient treatment through personalized diagnostics.

Advanced Genomics Solutions for SNP Genotyping and Sequencing-Based Early Cancer Detection

Room: 255A Time: 4:00 PM-4:50 PM Hosted by: Integrated DNA Technologies

Early, cancer risk detection is important to patients and to public health management. At this workshop, researchers will share their success partnering with IDT to use next generation sequencing methods that make such detection easy, accurate, and affordable. We will also describe a new genotyping solution from IDT: rhAmp™ SNP Genotyping, developed from our novel rhPCR technology. Join us to learn how this high performance, easy-to-use assay portfolio delivers sensitivity, accuracy, and cost effectiveness.

4:00 PM Continued

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Driving Signaling Pathways for Novel Therapeutic Options – Opportunities for Implementation and Interpretation

Room: 251A Time: 4:00 PM-4:50 PM Hosted by: Philips Healthcare

Current somatic sequencing-based methods which interrogate DNA for mutations uncover DNA damage, and, in-turn, help clinicians impute affected pathways. Using AI-informed knowledge-based models the activation of signal transduction pathways can be more precisely inferred, providing further insight into underlying cancer biology and new treatment strategies. We will show determination of activity of signaling pathways by measuring mRNA transcribed from direct target genes of pathway transcription factors, and applicability for treatment selection and monitoring for a broad range of cancers. Philips and N-of-one will present a seamless approach to combine AI methods with expert interpretation on molecular data from multiple sources.

Latest Advances in Precision Oncology Insights Utilizing Illumina’s TruSite Tumor 170 Assay

Room: 253B Time: 4:00 PM-4:50 PM Hosted by: PierianDx

Understanding the genetic underpinning of each patient’s tumor is a component of precision oncology, leading to more personalized clinical management. Illumina’s TruSight Tumor 170, a next-generation sequencing-based panel targets SNVs, indels, gene amplifications, gene fusions, splice variants, mRNA expression, and mRNA isoform detection found in 170 cancer-related genes as well as the ability to calculate metrics such as tumor mutation burden and determine evidence for microsatellite instability. A panel will discuss the design of the assay, data analytics, and reasons behind their selection of Illumina’s TST170 targeted cancer assay for tumor profiling at leading cancer centers.

Expanding the Latest Testing in Immuno-Oncology to the Clinic

Room: 250EF Time: 4:00 PM-4:50 PM Hosted by: Q2 Solutions

This talk will highlight how immuno-oncology testing is developed, explanation of output and its implications to the patient. We will review the current state of mutational burden in trials and considerations for using this across different sized genomic tests and implications to interpretation. Given light of implications of Microsatellite Instability (MSI) as a pan-cancer therapeutic marker, we will outline the approach to its testing and considerations for providing MSI testing in a clinical setting. Lastly, we will discuss expanding knowledge of testing through B/T-Cell repertoire testing, its current impact in clinical trials, use in biomarker discovery and implications to interpretation.

NOVEMBER 1-3, 2018Henry B. Gonzalez Convention Center

San Antonio, TX, USA

ANNUAL MEETING & EXPO

Precision Medicine Starts Here

4:00 PM Continued

NOVEMBER 1-3, 2018Henry B. Gonzalez Convention Center

San Antonio, TX, USA

ANNUAL MEETING & EXPO

Precision Medicine Starts Here

Rotterdam, The Netherlands

April 30 – May 2, 2018

AMPEUROPE 2018Achieving Dramatic Insights intoMolecular Oncology and Precision Medicine

www.amp-europe-congress.comScientifi c ProgramAMP – Association for Molecular PathologyBethesda, MD, USA

Legal Organizer & PCOMCI Deutschland GmbHT: +49 30 204590amp-europe@mci-group.com

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