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![© 2019. All rights reserved by PierianDx | Confidential 11
Financial ROI
Does Insourcing Make Cents?
“It does make financial
sense to [insource]...The
goal for our lab is to
maintain the send-out
volume at less than 5%
and keep the send out
costs at about 7-8% of the
total operating costs for
the lab.”
Eric Loo
Asst. Professor, Pathology & Lab
Medicine
Source: “Bringing NGS Testing In-House.” PierianDx
Webinar.
www.pieriandx.com
NGS Panel Direct
Variable
Complete Cost If Sent Out
Myeloid ~$75,000 ~$215,000 ~$325,000
Lung ~$70,000 ~$175,000 ~$300,000
Melanoma ~$20,000 ~$50,000 ~$90,000
~$165,000 ~$440,000 ~$715,000
Savings 76.79% 38.57%*
To Lab To Institution
*Dollar figures were altered for confidentiality. Savings are accurate.](https://image.slidesharecdn.com/pmwcpresentationfinal-190121235046/85/Building-a-Clinical-NGS-Program-11-320.jpg)
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Building a Clinical NGS Program
- 1. © 2019. Allrights reserved by PierianDx | Confidential 1 Rakesh Nagarajan, MD, PhD Executive Chairman and Founder Building a Clinical NGS Testing Program 2019 PMWC
- 2. © 2019. Allrights reserved by PierianDx | Confidential 2 Introduction to PierianDx Who We Are To improve patient lives by delivering the right genomic wisdom, in the right place, and at the right time. Prev: Assoc. Professor and Director at Washington University Curr: CAP Molecular Oncology Committee, Genomic Medicine Resource Committee, CAP Inspector Rakesh Nagarajan, MD, PhD Founder, Executive Chairman
- 3. © 2019. Allrights reserved by PierianDx | Confidential 3 Leaders in Clinical Genomics Pioneers in Precision Medicine 2003 WashU plays critical role in Human Genome Project. Today Full suite of software and services Independent CLIA/CAP “dry lab” 40+ medical center, cancer center, health system, and reference lab clients 200+ yrs of clinical genomics experience 2014 PierianDx est. after ~50 labs visit WashU to learn how clinical NGS is operationalized. 2011 WashU among first to validate and clinically report on somatic cancer NGS panels. 3
- 4. © 2019. Allrights reserved by PierianDx | Confidential 4 Wisdom in Every Report Helping Build Meaningful Precision Medicine Programs The largest clinical interpretation sharing network Most complete clinical genomics infrastructure Most clinically robust knowledgebase Most clinically experienced team
- 5. © 2019. Allrights reserved by PierianDx | Confidential 5 More Than Oncology Precision Medicine FDA Approved 284 Biomarkers 19 Therapeutic Areas 108 in Oncology Source: FDA - Table of Pharmacogenomic Biomarkers in Drug Labeling. Data as of June 2018
- 6. © 2019. Allrights reserved by PierianDx | Confidential 6 Source: Epstein Health Genetic/Genomic Testing US Market Snapshot 5.5 MM Total 2017 2020 8.0 MM Total Total Test Volumes Comprehensive Genomic Profiling 3.2 MM NGS 1.1 MM NGS Source: Boston Healthcare Associates 2016 Claims Data Labs Volume
- 7. © 2019. Allrights reserved by PierianDx | Confidential 7 IVDs are a Game Changer Commercial Pan-Cancer Assays 1+ 5-50 2011 <2011 2019 2017 500+ Provider Assay Genes PGDx PGDx 500+ Illumina TruSightTM Oncology 500 Memorial Sloan MSK-Impact 468 Foundation Medicine F1CDx 324 Illumina TruSightTM Tumor 170 ThermoFisher Oncomine 162 50+ Sold as kits for RUO/LDT Public plans for IVD Genes
- 8. © 2019. Allrights reserved by PierianDx | Confidential 8 Drive to Large Assays Tumor Profiling More Genes From single gene assays and small targeted hotspot panels to large capture-based assays and exome More Variant Types From SNVs and indels to copy number variants and gene fusions using both DNA and RNA samples More comprehensive detection of clinically relevant features ■ Tumor mutation load ■ Mutational signature ■ Confirm mRNA expression of mutations found at DNA level ■ Immunoprofiling ■ Inherited cancer risk (identified in 20% of cases) Mutational Signature (identify etiology and predict response to therapy) Mutational Load (determine candidacy for immunotherapy) HLA Typing (used for clinical trial enrollment)
- 9. © 2019. Allrights reserved by PierianDx | Confidential 9 Serial Testing is Vital Monitoring Tumor Clonality TumorGrowth Disease Progression Relapse1st Gen EGFR inhibitor Response DiagnosisHereditary Risk EGFR Ex19Del EGFR T790M EML4/ALK fusion ALK G1202R Crizotinib + 3rd Gen EGFR Inhibitor Response Relapse Making Cancer a Chronic Disease Hereditary cancer screening, early stage testing and serial monitoring hold the promise of making cancer a preventable and manageable disease. Amirouchene-Angelozzi,etal.“TumorEvolutionas aTherapeuticTarget”.CancerDiscover.Aug.2017
- 10. © 2019. Allrights reserved by PierianDx | Confidential 10 In-House vs. Send-Out Building Your Test Menu By Cancer Type Breast Genitourinary CNS Thoracic Myeloid, Lymphoid 0 I II III IV By Stage -I Head and Neck Melanoma Heme Solid TumorsHereditary Oncology Considerations ■ Cancer and variant type ■ DNA input requirements ■ Stage, monitoring ■ Turnaround times ■ Costs and reimbursement
- 11. © 2019. Allrights reserved by PierianDx | Confidential 11 Financial ROI Does Insourcing Make Cents? “It does make financial sense to [insource]...The goal for our lab is to maintain the send-out volume at less than 5% and keep the send out costs at about 7-8% of the total operating costs for the lab.” Eric Loo Asst. Professor, Pathology & Lab Medicine Source: “Bringing NGS Testing In-House.” PierianDx Webinar. www.pieriandx.com NGS Panel Direct Variable Complete Cost If Sent Out Myeloid ~$75,000 ~$215,000 ~$325,000 Lung ~$70,000 ~$175,000 ~$300,000 Melanoma ~$20,000 ~$50,000 ~$90,000 ~$165,000 ~$440,000 ~$715,000 Savings 76.79% 38.57%* To Lab To Institution *Dollar figures were altered for confidentiality. Savings are accurate.
- 12. © 2019. Allrights reserved by PierianDx | Confidential 12 Standard Implementation Top Challenges Amount of data to curate Validation of clinical testing protocols Scarcity of informatics expertise Expense of implementation Rapidly changing nature of technologies Reimbursement Uncertainty Test Validation Pre-Launch Preparation Training and Optimization Institutional Approval Initiate Planning Procure Equipment Go-Live 18-36 Months Top Barriers
- 13. © 2019. Allrights reserved by PierianDx | Confidential 13 Accelerated Implementation Our Goal with Client Labs Amount of data to curate Validation of clinical testing protocols Scarcity of informatics expertise Expense of implementation Rapidly changing nature of technologies Reimbursement Uncertainty Top Barriers <3 Months Test Validation Pre-Launch Preparation Training and Optimization Institutional Approval Initiate Planning Procure Equipment Go-Live 18-36 Months
- 14. © 2019. Allrights reserved by PierianDx | Confidential 14 Complete Clinical Support PierianDx Technology + Services Sample Processing Extraction, Library Prep Sequencing Variant Calling, (Bioinformatic Pipelines) Data Visualization, QC Analysis Variant Annotation, Classification, Prioritization Final Report & Medical Director Sign-out Data Integration EMR, 3rd Party Clinical Interpretation Classification & Reporting Clinical NGS Workflow Clinical Genomics Workspace + Knowledgebase Assay Validation Services Laboratory Services Interpretation Services Clinical Dry LabWet Lab Professional
- 15. © 2019. Allrights reserved by PierianDx | Confidential 15 Genomic Knowledgebase Most Accurate, Comprehensive and Up-to-Date Knowledge Sources Curated Assertions ■ FDA approved labels ■ NCCN, ASCO, guidelines ■ Active, recruiting trials Shared Medical Content ■ Medically signed-out interpretations ■ 10s of thousands of cases Public Data Sources ■ PubMed literature ■ Population frequencies ■ TCGA ■ COSMIC ■ ClinVar ■ OMIM ■ Emory ■ Invitae ■ dbNSFP Thousands of Genes ThousandsofCases 28,000 inferencing rules 1,100+ somatic genes curated 18 million+ published articles 6 Mb+ sequence coverage 100% Clinically Focused
- 16. © 2019. Allrights reserved by PierianDx | Confidential 16 Clinical Grade Informatics and Reporting REF Call Filtering Splice Variant Filter Re- Classification Sequence Alignment Variant Identification CNV Conversion Fusion Identification VCF Tag Display Primary Variant Filter Panel Filters Medical Interpretation Therapies Clinical Trials Auto Classification Case Accessioning CGW Pipeline CGW Panel Interpretation Services Review Patient Data Run QC DNA Only RNA Only DNA/RNA Lung Subpanel GIST Subpanel CNS Subpanel Colorectal Subpanel Melanoma Subpanel All Genes Review Case Data DNA QC Report Fastq DNA BAM RNA BAM DNA/RNA BAM Raw Variant Calls Final VCF RNA QC Report Draft Report Final Report Data Generation Procedure Selection Auto Interpretation Variant QC (IGV) HGVS Annotation
- 17. © 2019. Allrights reserved by PierianDx | Confidential 17 Implemented Assays All Bases Covered Assay Vendor Variant Types Input Files Amplicon Variant/Fusion Plex Archer SNVs, indels, fusions VCF, BAM VariantPlex BRCA1/BRCA2 Archer SNVs and indels VCF, BAM, BAI TruSight Myeloid Illumina SNVs and indels FASTQ, BAM, VCF TruSightTM Tumor 15 Illumina SNVs and indels FASTQ, BAM, VCF TruSightTM Tumor 26 Illumina SNVs and indels FASTQ, BAM, VCF TruSeqTM Cancer Amplicon Illumina SNVs and indels FASTQ, BAM, VCF BRCA1/BRCA2 (AFP2 assay) Illumina SNVs and indels FASTQ, BAM, VCF Oncomine (OCA) v2/3 Thermo Fisher SNVs, indels, CNVs, fusions BAM, VCF, BAI Ion AmpliSeq™ Cancer HotSpot Thermo Fisher SNVs and indels BAM, VCF, BAI Hybridization Capture Agilent probes Agilent SNVs, indels, fusions FASTQ, BAM, VCV Agilent/IDT probes Agilent/IDT SNVs, indels, fusions FASTQ, BAM, VCF TruSightTM Tumor 170 Illumina SNVs, indels, CNVs, fusions BAM, VCFs, CSV TruSightTM Cancer Illumina SNVs and indels FASTQ, BAM, VCF Ion AmpliSeq™ Inherited Cancer Thermo Fisher SNVs and indels VCF, BAM, BAI Haloplex Molecular barcodes/UMIs Agilent Haloplex Technology Agilent SNVs and indels FASTQ, BAM, VCF Somatic Fusions FusionPlex ALK/RET/ROS Archer Fusions FASTQ, BAM TruSightTM RNA fusion Illumina Fusions FASTQ, BAM, VCF Whole Exome Clinical Exome Agilent SureSelect Agilent SNVs and indels FASTQ, BAM TruSightTM One Illumina SNVs and indels FASTQ, BAM, VCF In Progress: RUO Future: IVD
- 18. © 2019. Allrights reserved by PierianDx | Confidential 18 Ex. PierianDx Supported Roadmap Oncology Testing Adoption Today 3 Months 12 Months 2+ Years All Solid Tumor All Solid Tumor TSO 500 ArcherDx Myeloid TSO 500 Lymphoid, Myeloid TSO 500 ArcherDx Myeloid 6 Months TruSight Cancer In-House Lab Services Send-Out Lymphoid, Myeloid Solid Tumor Hereditary Liquid Biopsy Liquid Biopsy Hereditary Cancer Hereditary Cancer Heme
- 19. © 2019. Allrights reserved by PierianDx | Confidential 19 Let Us Help! Building Your NGS Testing Program? Rakesh Nagarajan, MD, PhD Executive Chairman and Founder rakesh@pieriandx.com Resources Available www.pieriandx.com