Developing an Accurate and Precise Companion Diagnostic Assay for Targeted Therapies in DLBCL

Save this PDF as:
 WORD  PNG  TXT  JPG

Size: px
Start display at page:

Download "Developing an Accurate and Precise Companion Diagnostic Assay for Targeted Therapies in DLBCL"

Transcription

1 Developing an Accurate and Precise Companion Diagnostic Assay for Targeted Therapies in DLBCL James Storhoff, Ph.D. Senior Manager, Diagnostic Test Development World Cdx, Boston, Sep. 10th Molecules That Count 2012 NanoString Technologies, Inc. All rights reserved.

2 Presentation Overview Introduction to ncounter platform Discovery of a gene signature in DLBCL Lymphoma Subtyping Test: A Cdx IUO assay developed at NanoString and implemented as part of a global phase III trial in collaboration with Celgene

3 ncounter: The only direct, digital, nucleic-acid counting technology Molecular Barcoding Novel chemistry invented in Leroy Hood s lab at Institute of Systems Biology Probes up to 800 genes simultaneously Digital gene expression applied to biological pathways Single molecule fluorescent barcodes, each attached to an individual nucleic acid molecule 15

4 Digital Counting: How it Works (1 of 2) Target-specific Capture Probe Target-specific Reporter Probe Half Site 50 bases Half Site 50 bases Barcode Biotin

5 Digital Counting: How it Works (2 of 2) Half Site 50 bases Half Site 50 bases Barcode Biotin Measured Nucleic Acid

6 6 ncounter Assay Hybridize CodeSet to RNA Remove Excess Bind to Surface Immobilize and Align Image Surface Count Codes Target nucleic acid Capture and Reporter Probes ( CodeSet )

7 7 ncounter Assay Hybridize CodeSet to RNA Remove Excess Bind to Surface Immobilize and Align Image Surface Count Codes Hybridized mrna Excess Probes Removed

8 8 ncounter Assay Hybridize CodeSet to RNA Remove Excess Bind to Surface Immobilize and Align Image Surface Count Codes Hybridized Probes Bind to Cartridge Bottom of cartridge is coated with streptavidin

9 9 ncounter Assay Hybridize CodeSet to RNA Remove Excess Bind to Surface Immobilize and Align Image Surface Count Codes Immobilize and Align for Image Collecting and Barcode Counting +

10 10 ncounter Assay Hybridize CodeSet to RNA Remove Excess Bind to Surface Immobilize and Align Image Surface Count Codes One Coded Reporter = One RNA Molecule

11 11 ncounter Assay Hybridize CodeSet to RNA Remove Excess Bind to Surface Immobilize and Align Image Surface Count Codes Codes are Counted and Tabulated One Count = One Gene

12 Digital and Automated Workflow 5 min HANDS-ON Step 1 OVERNIGHT 5 min HANDS-ON Step HOURS, AUTOMATED 5 min HANDS-ON Step HOURS, AUTOMATED ncounter Prep Station ncounter Digital Analyzer 1 Hybridize 2 Purify 3 Count Flexible sample input requirements Only 4 pipetting steps/sample No amplification (except for single-cell) 800 hybridizations in a single tube Sensitive Precise Quantitative Simple

13 ncounter: Versatile and Validated Platform Gene Expression Copy Number Variation Single Cell Expression Multiple Applications mirna Expression Gene Fusions Proteins (In Early Access) Over 850 Peer-reviewed Publications The ncounter Dx Analysis System is FDA 510(k) cleared for use with the Prosigna Breast Cancer Prognostic Gene Signature Assay. To date, it has not been cleared by the FDA for other indications or for use with other assays. NanoString Confidential.

14 ncounter Product Portfolio: ncounter Reagents Advanced Disease Research Enable Clinical Testing Global Diagnostic Kits Advance Disease Research Enable Clinical Testing Globalize Diagnostic Kits Since 2009 Commercial Release: February 11, 2014 FDA-cleared: September 9, 2013 CodeSets Custom-built assays Standardized panels PanCancer pathways PanCancer immune profiling ncounter Elements Components to Develop Assays Registered with FDA Flexible Format Prosigna Prosigna Breast Cancer Assay IVD Test Kit CE Marked & launched in EU, Australia, Canada, Hong Kong, New Zealand, Israel, Turkey

15 Discovery to Companion Dx: NanoString LST January 2014 Researchers publish ncounter-based subtyping assay for Diffuse Large B Cell Lymphoma (DLBCL) May 2014 NanoString licenses DLBCL IP June 2014 Collaboration with Celgene to support development of REVLIMID as treatment for patients with DLBCL announced 21

16 DLBCL molecular subtypes first identified in 2000 Observed two dominant gene expression patterns in a set of DLBCL tumors First pattern clustered with gene expression from Germinal Center B-Cells Second pattern clustered gene expression from Activated Blood B-Cells Subtypes reflected the Cell of Origin Activated B-Cell-Like or ABC Germinal Center B-Cell-Like or GCB 16 Alizadeh; Nature 2000; 403,

17 The cell-of-origin is prognostic in R-CHOP treated patients Data show that ABC have worse outcome relative to GCB-type tumors when treated with R-CHOP Lenz; NEJM 2008; 359,

18 Targeted drugs in ABC type DLBCL 18 Roschewski; Nature Reviews in Clinical Oncology 2014; 11, 12-23

19 Cell-of-Origin subtypes have the potential to be predictive for benefit of Lenalidomide ABC/non-GCB subtype exhibits largest response to Lenalidomide 19 Nowakowski et al; JCO; 2014; 33(3):251-7

20 Implementation of Cell-of-Origin in the clinic was limited by gene expression profiling platforms DNA microarrays require fresh frozen tissue Clinical samples are FFPE DNA microarrays often exhibit site-to-site reproducibility Bias from enzymatic reactions Bias from operators In an effort to develop assays that could be translated into the clinic, researchers evaluated FFPE-based ncounter and IHC assays

21 Lymph2Cx Overview 20-Gene Signature for COO Classification FFPE-Compatible COO Classifiers IHC-based COO Assay Misclassification Rate: 6 17%* *Depends on interpretation method Established Prognostic Utility ncounter-based COO Assay ncounter-based Lymph2Cx Assay Misclassification Rate: 2%

22 Lymph2Cx Concordance Between Independent Laboratories 98% for biopsies with definitive COO 95% for all biopsies Scott et al; Blood; 2014

23 Clinical Study Design DLC-002 (ROBUST) Untreated DLBCL Central pathology confirmation ABC Select by GEP in real time GCB, unclassified R Lenalidomide 15 mg x 14 days + R-CHOP21 6 cycles* n=280 Placebo x 14 days + R-CHOP21 6 cycles* n=280 Ineligible Global Phase III study (CTG: NCT ) Select ABC subtype of DLBCL using ncounter gene expression profiling assay Lock down assay and algorithm prior to trial 23

24 Development of CDx: An Involved, Cross-Functional Effort Development Manufacturing Clinical Regulatory G&A Reagent Development Manufacturing Transfer Protocol Development Pre-IDE Alliance Management Assay Development Reagent Production Assay SOP transfer IDE submission Quality Control Process Validation Site qualification PMA submission Manufacturing Transfer System installation ExUS for global study Algorithm Training User training Software Development Physician training Site monitoring

25 Lymphoma Subtyping Test Overview for DLC-002 (ROBUST) Extract RNA from FFPE slide mounted tissue sections Process Patient Tumor RNA & RNA Reference Sample on ncounter Dx Analysis System Capture patient gene expression profile Apply Software Algorithm (Embedded) Data QC LPS = j a j X j Assign Subtype LPS: Linear Predictor Score; aj = weight for gene j, Xj = normalized gene expression value for gene j NanoString Confidential.

26 Feasibility, Dev. & Verification Testing Overview (Wallden et. al, JCO, 33, 2015; abst 8536) Testing Feasibility testing Development & Verification testing Reagent Development Accuracy of Algorithm > 500 assays (multiple lots of critical reagents) LLMPP Lymph 2Cx > 1000 assays run (multiple lots of critical reagents) Develop: 51 samples Verify: 68 samples Reproducibility 528 assays across 44 tissue samples 160 assays across 20 tissue samples Precision RNA input 176 assays (44 RNA samples x 3 kit lots) 15 RNA samples Input range of ng 120 assays (10 RNA samples x 3 kit lots x 2 users) 20 RNA samples Input range of ng 26

27 Conclusions LST CDx on ncounter platform The NanoString ncounter platform is well-suited to multiplexed genomic CDx The NanoString LST is being deployed in a pivotal phase III clinical trial From Publication to Clinical Study Initiation in ~250 Business Days 28

28 Project ChinOOK and the NanoString team

Tech Note. Using the ncounter Analysis System with FFPE Samples for Gene Expression Analysis. ncounter Gene Expression. Molecules That Count

Tech Note. Using the ncounter Analysis System with FFPE Samples for Gene Expression Analysis. ncounter Gene Expression. Molecules That Count ncounter Gene Expression Tech Note Using the ncounter Analysis System with FFPE Samples for Gene Expression Analysis Introduction For the past several decades, pathologists have kept samples obtained from

More information

First Annual Biomarker Symposium Quest Diagnostics Clinical Trials

First Annual Biomarker Symposium Quest Diagnostics Clinical Trials First Annual Biomarker Symposium Quest Diagnostics Clinical Trials Terry Robins, Ph.D. Director Biomarker R&D and Scientific Affairs Quest Diagnostics Clinical Trials Key Considerations: Biomarker Development

More information

Fusion Gene Analysis. ncounter Elements. Molecules That Count WHITE PAPER. v1.0 OCTOBER 2014 NanoString Technologies, Inc.

Fusion Gene Analysis. ncounter Elements. Molecules That Count WHITE PAPER. v1.0 OCTOBER 2014 NanoString Technologies, Inc. Fusion Gene Analysis NanoString Technologies, Inc. Fusion Gene Analysis ncounter Elements v1.0 OCTOBER 2014 NanoString Technologies, Inc., Seattle WA 98109 FOR RESEARCH USE ONLY. Not for use in diagnostic

More information

Sample Flexibility for Gene Expression Analysis with the ncounter Analysis System

Sample Flexibility for Gene Expression Analysis with the ncounter Analysis System Technical Note Sample Flexibility for Gene Expression Analysis with the ncounter Analysis System Sensitive Gene Expression Analysis From Crude Preparations and Fragmented RNA Cell Lysates Tissue Homogenates

More information

ncounter Elements TagSets General Purpose Reagents PACKAGE INSERT Molecules That Count NanoString Technologies, Inc.

ncounter Elements TagSets General Purpose Reagents PACKAGE INSERT Molecules That Count NanoString Technologies, Inc. ncounter Elements TagSets General Purpose Reagents PACKAGE INSERT NanoString Technologies, Inc. 530 Fairview Ave N Suite 2000 Seattle, Washington 98109 www.nanostring.com Tel: 206.378.6266 888.358.6266

More information

MICROARRAYS+SEQUENCING

MICROARRAYS+SEQUENCING MICROARRAYS+SEQUENCING The most efficient way to advance genomics research Down to a Science. www.affymetrix.com/downtoascience Affymetrix GeneChip Expression Technology Complementing your Next-Generation

More information

QIAGEN s NGS Solutions for Biomarkers NGS & Bioinformatics team QIAGEN (Suzhou) Translational Medicine Co.,Ltd

QIAGEN s NGS Solutions for Biomarkers NGS & Bioinformatics team QIAGEN (Suzhou) Translational Medicine Co.,Ltd QIAGEN s NGS Solutions for Biomarkers NGS & Bioinformatics team QIAGEN (Suzhou) Translational Medicine Co.,Ltd 1 Our current NGS & Bioinformatics Platform 2 Our NGS workflow and applications 3 QIAGEN s

More information

TECHNOLOGIES & SERVICES FOR THERAPEUTIC ANTIBODY DEVELOPMENT

TECHNOLOGIES & SERVICES FOR THERAPEUTIC ANTIBODY DEVELOPMENT Specialist in tissue analysis by Histology, Immunohistochemistry and In Situ Hybridization TECHNOLOGIES & SERVICES FOR THERAPEUTIC ANTIBODY DEVELOPMENT CONTENTS Histalim: who we are Our areas of expertise

More information

Roche, Roche Molecular Diagnostics and more

Roche, Roche Molecular Diagnostics and more , Molecular and more [Monte Wetzel, PhD] Patients have questions. We provide answers. Group Clear focus on Healthcare Innovation with two strong pillars Pharma Pharma Genentech Chugai Molecular Professional

More information

1 INTENDED USE / INDICATIONS FOR USE TABLE OF CONTENTS 2 SUMMARY OF THE TEST SYSTEM

1 INTENDED USE / INDICATIONS FOR USE TABLE OF CONTENTS 2 SUMMARY OF THE TEST SYSTEM www.nanostring.com Package Insert Prosigna Breast Cancer Prognostic Gene Signature Assay 14 LIMITATIONS OF THE PROCEDURES...10 15 EXPECTED VALUES...10 15.1 Distant Recurrence-Free Survival by Risk Categorization...

More information

NanoString Technologies. ncounter Analysis System. Digital Technology for Pathway-based Translational Research. Molecules That Count

NanoString Technologies. ncounter Analysis System. Digital Technology for Pathway-based Translational Research. Molecules That Count NanoString Technologies ncounter Analysis System Digital Technology for Pathway-based Translational Research Molecules That Count Gene Expression mirna Expression Epigenomics Copy Number Variation NanoString

More information

Introducing a Highly Integrated Approach to Translational Research: Biomarker Data Management, Data Integration, and Collaboration

Introducing a Highly Integrated Approach to Translational Research: Biomarker Data Management, Data Integration, and Collaboration Introducing a Highly Integrated Approach to Translational Research: Biomarker Data Management, Data Integration, and Collaboration 1 2 Translational Informatics Overview Precision s suite of services is

More information

Gene Regulation Solutions. Microarrays and Next-Generation Sequencing

Gene Regulation Solutions. Microarrays and Next-Generation Sequencing Gene Regulation Solutions Microarrays and Next-Generation Sequencing Gene Regulation Solutions The Microarrays Advantage Microarrays Lead the Industry in: Comprehensive Content SurePrint G3 Human Gene

More information

LiquidBiopsy LIQUIDBIOPSY. Automated Rare Template Isolation Platform

LiquidBiopsy LIQUIDBIOPSY. Automated Rare Template Isolation Platform LiquidBiopsy LIQUIDBIOPSY Automated Rare Template Isolation Platform Enabling cancer research with highly multiplexed molecular analysis of serially collected blood samples The LiquidBiopsy Platform simplifies

More information

IBBL: Introduction to Biobanks and their services

IBBL: Introduction to Biobanks and their services IBBL: Introduction to Biobanks and their services HighTech meets Health, Oss (NL), 15 th June 2017 Monica Marchese, PhD Biomarker Validation Scientist AN ACCREDITED & CERTIFIED BIOBANK INFRASTRUCTURE FOR

More information

Unblock your view. It will take your breath away. OncoScan FFPE Assay Kit Genome-wide copy number in 48 hours

Unblock your view. It will take your breath away. OncoScan FFPE Assay Kit Genome-wide copy number in 48 hours Unblock your view It will take your breath away OncoScan FFPE Assay Kit Genome-wide copy number in 48 hours Why is genome-wide copy number important in the analysis of solid tumors? The significance of

More information

DNA Microarray Technology

DNA Microarray Technology CHAPTER 1 DNA Microarray Technology All living organisms are composed of cells. As a functional unit, each cell can make copies of itself, and this process depends on a proper replication of the genetic

More information

ncounter Vantage 3D RNA:Protein Immune Cell Signaling Panel for Cell Suspensions

ncounter Vantage 3D RNA:Protein Immune Cell Signaling Panel for Cell Suspensions ncounter Vantage 3D RNA:Protein Immune Cell Signaling Panel for Cell Suspensions with Universal Cell Capture Kit Intracellular Compatible User Manual NanoString Technologies, Inc. 530 Fairview Ave North

More information

LATE-PCR. Linear-After-The-Exponential

LATE-PCR. Linear-After-The-Exponential LATE-PCR Linear-After-The-Exponential A Patented Invention of the Laboratory of Human Genetics and Reproductive Biology Lab. Director: Lawrence J. Wangh, Ph.D. Department of Biology, Brandeis University,

More information

Accessible answers. Targeted sequencing: accelerating and amplifying answers for oncology research

Accessible answers. Targeted sequencing: accelerating and amplifying answers for oncology research Accessible answers Targeted sequencing: accelerating and amplifying answers for oncology research Help advance precision medicine Accelerate results with Ion Torrent NGS Life without cancer. This is our

More information

Reflection paper on co-development of pharmacogenomic biomarkers and Assays in the context of drug development

Reflection paper on co-development of pharmacogenomic biomarkers and Assays in the context of drug development 1 2 3 24 June 2010 EMA/CHMP/641298/2008 Committee for Medicinal Products for Human Use (CHMP) 4 5 6 7 Reflection paper on co-development of pharmacogenomic biomarkers and Assays in the context of drug

More information

WELCOME. Norma J. Nowak, PhD Executive Director, NY State Center of Excellence in Bioinformatics and Life Sciences (CBLS)

WELCOME. Norma J. Nowak, PhD Executive Director, NY State Center of Excellence in Bioinformatics and Life Sciences (CBLS) WELCOME Norma J. Nowak, PhD Executive Director, NY State Center of Excellence in Bioinformatics and Life Sciences (CBLS) Director, UB Genomics and Bioinformatics Core (GBC) o o o o o o o o o o o o Grow

More information

Ion S5 and Ion S5 XL Systems

Ion S5 and Ion S5 XL Systems Ion S5 and Ion S5 XL Systems Targeted sequencing has never been simpler Explore the Ion S5 and Ion S5 XL Systems Adopting next-generation sequencing (NGS) in your lab is now simpler than ever The Ion S5

More information

3.1.4 DNA Microarray Technology

3.1.4 DNA Microarray Technology 3.1.4 DNA Microarray Technology Scientists have discovered that one of the differences between healthy and cancer is which genes are turned on in each. Scientists can compare the gene expression patterns

More information

with Cell Surface-Compatible Universal Cell Capture Kit

with Cell Surface-Compatible Universal Cell Capture Kit MAN-10066-01 with Cell Surface-Compatible Universal Cell Capture Kit In this workflow, cells are collected and then bound to the Universal Cell Capture Beads; then the RNA and Protein samples are prepared

More information

Applications of In Situ Hybridisation in Research and Disease

Applications of In Situ Hybridisation in Research and Disease Cancer Research UK Cambridge Institute Applications of In Situ Hybridisation in Research and Disease 7 8 May 2015 Programme Applications of In Situ Hybridisation in Research and Disease 11 Thursday 7 May

More information

American Society of Cytopathology Core Curriculum in Molecular Biology

American Society of Cytopathology Core Curriculum in Molecular Biology American Society of Cytopathology Core Curriculum in Molecular Biology American Society of Cytopathology Core Curriculum in Molecular Biology Chapter 4 Stephanie A. Hamilton, EdD, SCT, MB(ASCP) CM MD Anderson

More information

High Cross-Platform Genotyping Concordance of Axiom High-Density Microarrays and Eureka Low-Density Targeted NGS Assays

High Cross-Platform Genotyping Concordance of Axiom High-Density Microarrays and Eureka Low-Density Targeted NGS Assays High Cross-Platform Genotyping Concordance of Axiom High-Density Microarrays and Eureka Low-Density Targeted NGS Assays Ali Pirani and Mohini A Patil ISAG July 2017 The world leader in serving science

More information

Product selection guide Ion GeneStudio S5 Series

Product selection guide Ion GeneStudio S5 Series Cancer genomics research Molecular profiling Ion AmpliSeq Comprehensive Cancer Panel Cat. No. 4477685 Ion AmpliSeq Made-to-Order Panels (Customize your own or browse redesigned community panels at ampliseq.com)

More information

TheraLin. Universal Tissue Fixative Enabling Molecular Pathology

TheraLin. Universal Tissue Fixative Enabling Molecular Pathology TheraLin Universal Tissue Fixative Enabling Molecular Pathology TheraLin Universal Tissue Fixative Enabling Molecular Pathology Contents Page # TheraLin Universal Tissue Fixative 3 Introduction 5 Easy

More information

CHARTING THE COURSE FOR PRECISION MEDICINE

CHARTING THE COURSE FOR PRECISION MEDICINE A Friends of Cancer Research White Paper CHARTING THE COURSE FOR PRECISION MEDICINE ADOPTING CONSENSUS ANALYTICAL STANDARDS AND STREAMLINING APPROVAL PATHWAYS FOR POST-MARKET MODIFICATIONS FOR NGS TESTS

More information

Webinar July 9, Noon. The Essentials of Diagnostics: Introduction to Molecular Diagnostics

Webinar July 9, Noon. The Essentials of Diagnostics: Introduction to Molecular Diagnostics Webinar July 9, 2013 12 Noon The Essentials of Diagnostics: Introduction to Molecular Diagnostics 1 DxInsights mission is to educate healthcare stakeholders on the power and value of diagnostics and their

More information

PAXgene Blood DNA PAXgene Blood DNA Tube (IVD) for clinical use PAXgene Blood DNA System (RUO) for research use. Explore more at

PAXgene Blood DNA PAXgene Blood DNA Tube (IVD) for clinical use PAXgene Blood DNA System (RUO) for research use. Explore more at PAXgene Blood DNA PAXgene Blood DNA Tube (IVD) for clinical use PAXgene Blood DNA System (RUO) for research use Explore more at www.preanalytix.com Situation The composition, amount, quality and integrity

More information

GENE EXPRESSION REAGENTS MARKETS (SAMPLE COPY, NOT FOR RESALE)

GENE EXPRESSION REAGENTS MARKETS (SAMPLE COPY, NOT FOR RESALE) TriMark Publications April 2007 Volume: TMRGER07-0401 GENE EXPRESSION REAGENTS MARKETS (SAMPLE COPY, NOT FOR RESALE) Trends, Industry Participants, Product Overviews and Market Drivers TABLE OF CONTENTS

More information

TaqPath ProAmp Master Mixes

TaqPath ProAmp Master Mixes PRODUCT BULLETIN es es Applied Biosystems TaqPath ProAmp Master Mixes are versatile master mixes developed for high-throughput genotyping and copy number variation (CNV) analysis protocols that require

More information

DNA Workflow. Marine Biological Laboratory. Mark Bratz Applications Scientist, Promega Corporation. August 2016

DNA Workflow. Marine Biological Laboratory. Mark Bratz Applications Scientist, Promega Corporation. August 2016 DNA Workflow Marine Biological Laboratory Mark Bratz Applications Scientist, August 2016 Scientific Applications Support Mission Realize customer driven applications of Promega technologies to enhance

More information

NanoString Sample Submission Guidelines

NanoString Sample Submission Guidelines High quality ncounter data is achieved with high quality starting material. The guidelines set forth in this document will assist you in preparing your samples for your NanoString run. Please adhere to

More information

Oncomine cfdna Assays Part III: Variant Analysis

Oncomine cfdna Assays Part III: Variant Analysis Oncomine cfdna Assays Part III: Variant Analysis USER GUIDE for use with: Oncomine Lung cfdna Assay Oncomine Colon cfdna Assay Oncomine Breast cfdna Assay Catalog Numbers A31149, A31182, A31183 Publication

More information

Welcome to the NGS webinar series

Welcome to the NGS webinar series Welcome to the NGS webinar series Webinar 1 NGS: Introduction to technology, and applications NGS Technology Webinar 2 Targeted NGS for Cancer Research NGS in cancer Webinar 3 NGS: Data analysis for genetic

More information

Applications of the Ion AmpliSeq Immune Repertoire Assay Plus TCRβ

Applications of the Ion AmpliSeq Immune Repertoire Assay Plus TCRβ Applications of the Ion AmpliSeq Immune Repertoire Assay Plus TCRβ Timothy Looney, PhD Staff Scientist, Clinical Next-Generation Sequencing Division Thermo Fisher Scientific The world leader in serving

More information

FirePlex mirna Assay. Multiplex microrna profiling from low sample inputs

FirePlex mirna Assay. Multiplex microrna profiling from low sample inputs FirePlex mirna Assay Multiplex microrna profiling from low sample inputs Abstract We introduce a new assay for multiplex microrna (mirna) discovery and verification that enables simultaneous profiling

More information

IQFISH on Dako Omnis. Panel for Lung Cancer. Dako FAST RESULTS. ALK, ROS1, RET and MET IQFISH. Dako Omnis. Agilent Pathology Solutions

IQFISH on Dako Omnis. Panel for Lung Cancer. Dako FAST RESULTS. ALK, ROS1, RET and MET IQFISH. Dako Omnis. Agilent Pathology Solutions PRODUCT INFORMATION Dako Omnis ALK, ROS1, RET and MET IQFISH Dako Agilent Pathology Solutions IQFISH on Dako Omnis Panel for Lung Cancer FAST RESULTS Fast, high-quality FISH Integrated into your IHC workflow

More information

Personalised Healthcare Solutions (PHCS) Excellence for your Biomarker-driven Strategies

Personalised Healthcare Solutions (PHCS) Excellence for your Biomarker-driven Strategies Personalised Healthcare Solutions (PHCS) Excellence for your Biomarker-driven Strategies The value of In Vitro Diagnostics The value of diagnostics as an integral part in the healthcare value chain Diagnostics

More information

Towards detection of minimal residual disease in multiple myeloma through circulating tumour DNA sequence analysis

Towards detection of minimal residual disease in multiple myeloma through circulating tumour DNA sequence analysis Towards detection of minimal residual disease in multiple myeloma through circulating tumour DNA sequence analysis Trevor Pugh, PhD, FACMG Princess Margaret Cancer Centre, University Health Network Dept.

More information

NanoString Assay Sample Type Assay Input Amount Required Sample Amount/Concentration Total RNA 100ng no less than 150ng, normalized to 20ng/µl

NanoString Assay Sample Type Assay Input Amount Required Sample Amount/Concentration Total RNA 100ng no less than 150ng, normalized to 20ng/µl High quality ncounter data is achieved with high quality starting material. The guidelines set forth in this document will assist you in preparing your samples for your NanoString run. Please adhere to

More information

All your genetic analyses on a single instrument

All your genetic analyses on a single instrument GENOMELAB GEXP GENETIC ANALYSIS SYSTEM All your genetic analyses on a single instrument GENOMELAB GEXP GENETIC ANALYSIS SYSTEM All on a single instrument Perform your genetic assays on one instrument A

More information

QuantStudio Dx Real-Time PCR Instrument

QuantStudio Dx Real-Time PCR Instrument QuantStudio Dx Real-Time PCR Instrument Behind every diagnosis, there is a promise You believe in molecular medicine. So do we. We are committed to providing you with comprehensive solutions that help

More information

Alere q. A platform to answer global health needs: TB and beyond. Duncan Blair Director, Public Health Initiatives

Alere q. A platform to answer global health needs: TB and beyond. Duncan Blair Director, Public Health Initiatives Alere q A platform to answer global health needs: TB and beyond Duncan Blair Director, Public Health Initiatives 7 th FIND Symposium, Barcelona, October 2014 Alere q platform overview Comprising the Alere

More information

Product selection guide Ion S5 and Ion S5 XL Systems

Product selection guide Ion S5 and Ion S5 XL Systems Product selection guide Ion S5 and s Cancer genomics research Molecular profiling Ion AmpliSeq Ready-to-Use Panels Ion AmpliSeq Comprehensive Cancer Panel Cat. No. 4477685 Ion AmpliSeq Made-to-Order Panels

More information

Quality of Cancer RNA Samples Is Essential for Molecular Classification Based on Microarray Results Application

Quality of Cancer RNA Samples Is Essential for Molecular Classification Based on Microarray Results Application Quality of Cancer RNA Samples Is Essential for Molecular Classification Based on Microarray Results Application Pathology Author Jenny Xiao Agilent Technologies, Inc. Deer Creek Road MC U-7 Palo Alto,

More information

Preanalytical Processing: The Biospecimen Quality Imperative

Preanalytical Processing: The Biospecimen Quality Imperative Preanalytical Processing: The Biospecimen Quality Imperative Carolyn Compton, MD, PhD Chair, Scientific Advisory Committee, Indivumed GmbH Professor of Life Sciences, ASU Professor of Laboratory Medicine

More information

AmoyDx TM PIK3CA Five Mutations Detection Kit

AmoyDx TM PIK3CA Five Mutations Detection Kit AmoyDx TM PIK3CA Five Mutations Detection Kit Detection of five mutations in PIK3CA gene Instructions For Use Instructions Version: B1.3 Date of Revision: April 2012 Store at -20±2 1/5 Background Phosphatidylinositol

More information

Systematic Analysis of single cells by PCR

Systematic Analysis of single cells by PCR Systematic Analysis of single cells by PCR Wolfgang Mann 27th March 2007, Weihenstephan Overview AmpliGrid Technology Examples DNA Forensics Single Cell Sequencing Polar Body Diagnostics Single Cell RT

More information

Biomarker Data Management in Clinical Trials: Addressing the Challenges of the New Regulatory Landscape

Biomarker Data Management in Clinical Trials: Addressing the Challenges of the New Regulatory Landscape Biomarker Data Management in Clinical Trials: Addressing the Challenges of the New Regulatory Landscape Introduction Biomarkers and specialty labs are core to modern clinical trials.the broad and evergrowing

More information

GENERAL PAYER CONSIDERATIONS FOR NEW HEALTH TECHNOLOGIES (INCLUDING DIAGNOSTICS)

GENERAL PAYER CONSIDERATIONS FOR NEW HEALTH TECHNOLOGIES (INCLUDING DIAGNOSTICS) FORUM Payer perspectives and actions impacting diagnostics in the US and Europe Eric Faulkner, MPH Director, Quintiles Global Market Access Consulting; Executive Director, Genomics Biotech Emerging Medical

More information

ACCEL-NGS 2S DNA LIBRARY KITS

ACCEL-NGS 2S DNA LIBRARY KITS ACCEL-NGS 2S DNA LIBRARY KITS Accel-NGS 2S DNA Library Kits produce high quality libraries with an all-inclusive, easy-to-use format. The kits contain all reagents necessary to build high complexity libraries

More information

Cancer Genetics Solutions

Cancer Genetics Solutions Cancer Genetics Solutions Cancer Genetics Solutions Pushing the Boundaries in Cancer Genetics Cancer is a formidable foe that presents significant challenges. The complexity of this disease can be daunting

More information

Ariol. Clinical IHC and FISH Breast Marker Analysis Quality. Efficiency. Confidence.

Ariol. Clinical IHC and FISH Breast Marker Analysis Quality. Efficiency. Confidence. Ariol Clinical IHC and FISH Breast Marker Analysis Quality. Efficiency. Confidence. 3 Behind every breast slide in your laboratory is a woman waiting for life changing answers With over 1.25 million women

More information

Aligning Lab Goals & Institutional Goals Laughlin Rice

Aligning Lab Goals & Institutional Goals Laughlin Rice Aligning Lab Goals & Institutional Goals Laughlin Rice Senior Administrative Director Department of Pathology & Laboratory Medicine The Children s Hospital of Learning Objectives To understand the institutional

More information

PCR SYSTEMS. a new era in high-productivity qpcr. Applied Biosystems ViiA 7 Real-Time PCR System

PCR SYSTEMS. a new era in high-productivity qpcr. Applied Biosystems ViiA 7 Real-Time PCR System PCR SYSTEMS a new era in high-productivity qpcr Applied Biosystems ViiA 7 Real-Time PCR System a new era in high-productivity qpcr The ViiA 7 Real-Time PCR System delivers the proven reliability, sensitivity,

More information

RIPTIDE HIGH THROUGHPUT RAPID LIBRARY PREP (HT-RLP)

RIPTIDE HIGH THROUGHPUT RAPID LIBRARY PREP (HT-RLP) Application Note: RIPTIDE HIGH THROUGHPUT RAPID LIBRARY PREP (HT-RLP) Introduction: Innovations in DNA sequencing during the 21st century have revolutionized our ability to obtain nucleotide information

More information

Single Cell Genomics (SCG): Market Size, Segmentation, Growth, Competition and Trends ( )

Single Cell Genomics (SCG): Market Size, Segmentation, Growth, Competition and Trends ( ) Single Cell Genomics (SCG): Market Size, Segmentation, Growth, Competition and Trends (2013-2021) May, 2017 3 rd Edition Information contained in this market report is believed to be reliable at the time

More information

Kinase Activity: a total solution

Kinase Activity: a total solution Kinase Activity: a total solution Protein arrays for multiplex kinetic measurements Robust Instrumentation User friendly software Kinetic data at your fingertips! PamGene s novel platform for profiling

More information

Ion S5 and Ion S5 XL Systems

Ion S5 and Ion S5 XL Systems Ion S5 and Ion S5 XL Systems Targeted sequencing has never been simpler Introducing the Ion S5 and Ion S5 XL systems Now, adopting next-generation sequencing in your lab is simpler than ever. The Ion S5

More information

Molecular Diagnostics OEM and Commercial Supply Services. Your partners for success

Molecular Diagnostics OEM and Commercial Supply Services. Your partners for success Molecular Diagnostics OEM and Commercial Supply Services Your partners for success We enable the success of our molecular diagnostics partners in the development and commercialization of integrated solutions

More information

Comments from the FDA Working Group on SUBGROUP ANALYSES. Estelle Russek-Cohen, Ph.D. U.S. Food and Drug Administration Center for Biologics

Comments from the FDA Working Group on SUBGROUP ANALYSES. Estelle Russek-Cohen, Ph.D. U.S. Food and Drug Administration Center for Biologics Comments from the FDA Working Group on SUBGROUP ANALYSES Estelle Russek-Cohen, Ph.D. U.S. Food and Drug Administration Center for Biologics 1 Outline An intro to FDA EMA and FDA on subgroups Companion

More information

MIRACLE Isolation & analysis for single circulating tumor cells (CTC) in an integrated microsystem

MIRACLE Isolation & analysis for single circulating tumor cells (CTC) in an integrated microsystem MIRACLE Isolation & analysis for single circulating tumor cells (CTC) in an integrated microsystem Wolfgang Eberle, Chengxun Liu, Liesbet Lagae Imec, Leuven, Belgium - contact: Chengxun.liu@imec.be MNBS

More information

Next Generation Sequencing. Target Enrichment

Next Generation Sequencing. Target Enrichment Next Generation Sequencing Target Enrichment Next Generation Sequencing Your Partner in Every Step from Sample to Data NGS: Revolutionizing Genetic Analysis with Single-Molecule Resolution Next generation

More information

MicroSEQ Rapid Microbial Identification System

MicroSEQ Rapid Microbial Identification System MicroSEQ Rapid Microbial Identification System Giving you complete control over microbial identification using the gold-standard genotypic method The MicroSEQ ID microbial identification system, based

More information

Targeted Sequencing in the NBS Laboratory

Targeted Sequencing in the NBS Laboratory Targeted Sequencing in the NBS Laboratory Christopher Greene, PhD Newborn Screening and Molecular Biology Branch Division of Laboratory Sciences Gene Sequencing in Public Health Newborn Screening February

More information

Symphony Genomics Workflow Management System Managing, Integrating, and Delivering Your NGS Data and Results

Symphony Genomics Workflow Management System Managing, Integrating, and Delivering Your NGS Data and Results Symphony Genomics Workflow Management System Managing, Integrating, and Delivering Your NGS Data and Results Precision Genomics for Immuno-Oncology www.personalis.com info@personalis.com 1 855-GENOME4

More information

TIME IT S PRIME. chemagic TM Prime TM instrument Streamlined Walk-away Automation. For all Human Sample Materials. Primary Sample Handling

TIME IT S PRIME. chemagic TM Prime TM instrument Streamlined Walk-away Automation. For all Human Sample Materials. Primary Sample Handling IT S PRIME TIME chemagic TM Prime TM instrument Streamlined Walk-away Automation. For all Human Sample Materials. Primary Sample Nucleic Acid Isolation Eluate Quantitation of Extracted Samples Assay Setup

More information

QIAGEN Sample & Assay Technologies From Discovery to Patient

QIAGEN Sample & Assay Technologies From Discovery to Patient QIAGEN From Discovery to Patient New York, February 14 QIAGEN 2008 Analyst & Investor Day Peer Schatz, CEO -7- Forward Looking Statements Safe Harbor Statement: Certain of the statements contained in this

More information

The In Vitro Diagnostic CRO

The In Vitro Diagnostic CRO The In Vitro Diagnostic CRO Choose Beaufort Because of Our People, Processes and Proven Experience The value of expertise cannot be overstated, especially when it comes to streamlining complicated in vitro

More information

2100 Bioanalyzer. Overview & News. Ralph Beneke Dec 2010

2100 Bioanalyzer. Overview & News. Ralph Beneke Dec 2010 2100 Bioanalyzer Overview & News Ralph Beneke Dec 2010 RNA QC in Gene Expression Workflows Cited in over 10,000 peer-reviewed papers RIN is the industry standard for RNA QC For any size and at low sample

More information

Proteomics And Cancer Biomarker Discovery. Dr. Zahid Khan Institute of chemical Sciences (ICS) University of Peshawar. Overview. Cancer.

Proteomics And Cancer Biomarker Discovery. Dr. Zahid Khan Institute of chemical Sciences (ICS) University of Peshawar. Overview. Cancer. Proteomics And Cancer Biomarker Discovery Dr. Zahid Khan Institute of chemical Sciences (ICS) University of Peshawar Overview Proteomics Cancer Aims Tools Data Base search Challenges Summary 1 Overview

More information

Agenda. - Introduction Howard Birndorf. - ASR Issues and the Draft ASR FAQ Guidance Patrick Balthrop

Agenda. - Introduction Howard Birndorf. - ASR Issues and the Draft ASR FAQ Guidance Patrick Balthrop - Introduction Howard Birndorf Agenda - ASR Issues and the Draft ASR FAQ Guidance Patrick Balthrop - IVDMIA Issues and the Draft IVDMIA Guidance Randy Scott - Q&A and Discussion All Who Are We? - Emerging

More information

Expression Array System

Expression Array System Integrated Science for Gene Expression Applied Biosystems Expression Array System Expression Array System SEE MORE GENES The most complete, most sensitive system for whole genome expression analysis. The

More information

Archer ALK, RET, ROS1 Fusion Detection v1 Illumina Platform

Archer ALK, RET, ROS1 Fusion Detection v1 Illumina Platform Archer ALK, RET, ROS1 Fusion Detection v1 Illumina Platform P/N AK0001-8 Archer ALK, RET, ROS1 Fusion Detection v1 for Illumina Platform IFU-AK0001-8 Rev. A Table of Contents Product Description..3 Workflow

More information

Maxwell RSC System. Next Generation Automated Purification and Quantitation

Maxwell RSC System. Next Generation Automated Purification and Quantitation Maxwell RSC System Next Generation Automated Purification and Quantitation INTRODUCTION/OVERVIEW The Maxwell RSC System Your personal purification assistant. It easily integrates into any laboratory workflow,

More information

Improving the Limit of Detection of Lateral Flow Assays using 3DNA Technology

Improving the Limit of Detection of Lateral Flow Assays using 3DNA Technology Improving the Limit of Detection of Lateral Flow Assays using 3DNA Technology Introduction Lateral Flow (LF) and similar assays represent a unique growing class of Point of Care (POC) tests designed to

More information

PlexSet Reagents User Manual

PlexSet Reagents User Manual PlexSet Reagents User Manual For Research Use Only. Not for use in diagnostic procedures. MAN-10040-03 October 2017 ncounter PlexSet Reagents for Gene Expression User Manual MAN-10040-03 PlexSet Reagents

More information

Microarray Gene Expression Analysis at CNIO

Microarray Gene Expression Analysis at CNIO Microarray Gene Expression Analysis at CNIO Orlando Domínguez Genomics Unit Biotechnology Program, CNIO 8 May 2013 Workflow, from samples to Gene Expression data Experimental design user/gu/ubio Samples

More information

BIOCRATES Life Sciences AG Short Company Presentation

BIOCRATES Life Sciences AG Short Company Presentation BIOCRATES Life Sciences AG Short Company Presentation Dr. Alexandra C. Gruber MBA MMFin Director Business Development / Marketing Austria Showcase Life Science Japan, Tokyo, December 2010 BIOCRATES Life

More information

Current Best Practices in Commercial Kit Evaluation and Validation for Biomarker Assays

Current Best Practices in Commercial Kit Evaluation and Validation for Biomarker Assays Current Best Practices in Commercial Kit Evaluation and Validation for Biomarker Assays 10th Workshop on Recent Issues in Bioanalysis, 2016 Paul Rhyne, Ph.D. - Director of Immunoassay Services Copyright

More information

Innovations in Molecular Lab Operation. Joseph M. Campos, PhD, D(ABMM), F(AAM)

Innovations in Molecular Lab Operation. Joseph M. Campos, PhD, D(ABMM), F(AAM) Innovations in Molecular Lab Operation Lessons in the Best Ways to Blend Automation, Lean Workflow, and Paperless Processes Joseph M. Campos, PhD, D(ABMM), F(AAM) Interim Chief, Division of Laboratory

More information

Next Generation Sequencing for Gene Fusion Detection: A Complementary Tool for Cytogenetics

Next Generation Sequencing for Gene Fusion Detection: A Complementary Tool for Cytogenetics Next Generation Sequencing for Gene Fusion Detection: A Complementary Tool for Cytogenetics Ravindra Kolhe, MD, PhD Assistant Professor of Pathology Medical Director, AUMC Cytogenetics laboratory Laboratory

More information

Target Enrichment Strategies for Next Generation Sequencing

Target Enrichment Strategies for Next Generation Sequencing Target Enrichment Strategies for Next Generation Sequencing Anuj Gupta, PhD Agilent Technologies, New Delhi Genotypic Conference, Sept 2014 NGS Timeline Information burst Nearly 30,000 human genomes sequenced

More information

Assay I nput Amount. varied (amplification 1 cell or 10pg RNA 10pg- 10ng. 100ng. 1-3ul. varied (5-10µL)

Assay I nput Amount. varied (amplification 1 cell or 10pg RNA 10pg- 10ng. 100ng. 1-3ul. varied (5-10µL) High quality ncounter data is achieved with samples that meet NanoString assay requirements. The guidelines set forth in this document will assist you in preparing your samples prior to submission to NanoString.

More information

Introduction To Real-Time Quantitative PCR (qpcr)

Introduction To Real-Time Quantitative PCR (qpcr) Introduction To Real-Time Quantitative PCR (qpcr) Samuel Rulli, Ph.D. Samuel.Rulli@QIAGEN.com Technical Support: BRCsupport@qiagen.com The products described in this webinar are intended for molecular

More information

The New EU IVDR. Overview of the Main Changes & Clinical Data Requirements. Advance Regulatory Consulting Ltd.

The New EU IVDR. Overview of the Main Changes & Clinical Data Requirements. Advance Regulatory Consulting Ltd. Overview of the Main Changes & Clinical Data Requirements Advance Regulatory Consulting Ltd. : Timeline: Entry in to force Q2 (Apr) 2017 Adoption: +6m NB s apply for designation IVDs classified as Class

More information

SMARTer Ultra Low RNA Kit for Illumina Sequencing Two powerful technologies combine to enable sequencing with ultra-low levels of RNA

SMARTer Ultra Low RNA Kit for Illumina Sequencing Two powerful technologies combine to enable sequencing with ultra-low levels of RNA SMARTer Ultra Low RNA Kit for Illumina Sequencing Two powerful technologies combine to enable sequencing with ultra-low levels of RNA The most sensitive cdna synthesis technology, combined with next-generation

More information

Technology Development Funding Program Round 3

Technology Development Funding Program Round 3 Technology Development Funding Program Round 3 CWRU January 26, 2015 1 Program Overview NIH Center for Accelerated Innovations (NCAI) at Cleveland Clinic Mission to improve translation of basic science

More information

sirna Overview and Technical Tips

sirna Overview and Technical Tips 1 sirna Overview and Technical Tips 2 CONTENTS 3 4 5 7 8 10 11 13 14 18 19 20 21 Introduction Applications How Does It Work? Handy Tips Troubleshooting Conclusions Further References Contact Us 3 INTRODUCTION

More information

Roche Molecular Biochemicals Technical Note No. LC 10/2000

Roche Molecular Biochemicals Technical Note No. LC 10/2000 Roche Molecular Biochemicals Technical Note No. LC 10/2000 LightCycler Overview of LightCycler Quantification Methods 1. General Introduction Introduction Content Definitions This Technical Note will introduce

More information

Technical note: Molecular Index counting adjustment methods

Technical note: Molecular Index counting adjustment methods Technical note: Molecular Index counting adjustment methods By Jue Fan, Jennifer Tsai, Eleen Shum Introduction. Overview of BD Precise assays BD Precise assays are fast, high-throughput, next-generation

More information

Molecular Diagnostics

Molecular Diagnostics Molecular Diagnostics Positioning the Laboratory for the Future Through Scalable Lab Developed Test Workflows, Clinical-level Quality, & Operational Efficiency Path to the heart of healthcare Change It

More information

ACCELERATING GENOMIC ANALYSIS ON THE CLOUD. Enabling the PanCancer Analysis of Whole Genomes (PCAWG) consortia to analyze thousands of genomes

ACCELERATING GENOMIC ANALYSIS ON THE CLOUD. Enabling the PanCancer Analysis of Whole Genomes (PCAWG) consortia to analyze thousands of genomes ACCELERATING GENOMIC ANALYSIS ON THE CLOUD Enabling the PanCancer Analysis of Whole Genomes (PCAWG) consortia to analyze thousands of genomes Enabling the PanCancer Analysis of Whole Genomes (PCAWG) consortia

More information

Gene Expression on the Fluidigm BioMark HD

Gene Expression on the Fluidigm BioMark HD Gene Expression on the Fluidigm BioMark HD Overview Introduction to Fluidigm James Miller Advantages of the technology Running a Fluidigm gene expression project Paul Lacaze Assay design, chemistry, experimental

More information

How to Choose the Right Equipment/Platforms for your Laboratory

How to Choose the Right Equipment/Platforms for your Laboratory How to Choose the Right Equipment/Platforms for your Laboratory (A Public Hospital Laboratory Perspective) Michelle J. Francis Overview Public Hospital Pressures / Challenges Commercial vs In-house assays

More information