Quanterix Corporation · NASDAQ:QTRX
Quanterix — Technical Presentation (October 2015)
26 slides from Quanterix's technical presentation, October 2015
Slide 1: Development, Validation, and Application of Ultrasensitive Simoa-based Immunoassays for Prospective Clinical Trials
Development, Validation, and Application of Ultrasensitive Simoa-based Immunoassays for Prospective Clinical Trials Dominic Eisinger, Ph.D. October, 2015 1
Slide 2: Outline
Outline Myriad RBM: Company Overview Simoa Services: Assay Design, Validation & Performance Assays in Development Applications Q&A 2
Slide 3: Myriad RBM Testing Lab
Myriad RBM Testing Lab As of October 15, 2015: 3
Slide 4: Myriad RBM – Company Overview
Myriad RBM – Company Overview • RBM -Founded in 1998 as a division of Luminex; spun-out in 2002 • Pharmaceutical Services Business: provides multiplex immunoassay testing services • CLIA Reference Lab in Austin, TX • Purchased by Myriad Genetics – May 31, 2011 • Purchased Crescendo Biosciences – Mar
Slide 5: Myriad Genetics
Myriad Genetics Myriad Genetics is dedicated to saving lives and improving the quality of life of patients through the discovery and commercialization of novel, transformative diagnostic tests across major diseases • Largest molecular diagnostic clinical laboratory in the world • Global leader in he
Slide 6: Myriad RBM provides the following product and service offerings
Myriad RBM provides the following product and service offerings: eo HumanM&Ps CustomM®P Builder DiscoveryMAP® ImmunoMAP® If a smaller, more focused panel of analytes is OncologyMAP® NeuroMAP™ required, we can build a Custom MAP to HumanMAP® MetabolicMAP® meet your needs. ExplorerMAP KidneyMAP* Cardi
Slide 7: Simoa Services: Assay Design, Validation & Performance
Simoa Services: Assay Design, Validation & Performance 7
Slide 8: Simoa Assay Development: Feasibility
Simoa Assay Development: Feasibility Antibody pair screen Standard screen Proprietary blockers tested Sample screen - normal serum & plasma, disease, heterophile, & TruCulture® Linearity & spike recovery Correlation to ELISA if applicable Specificity - antibody competition 8
Slide 9: Simoa Assay Development
Simoa Assay Development Bead, detection titration, all diluent SbG titration, RGP Standard, background and dynamic range Controls - at least one level is normal human serum 9
Slide 10: Simoa Assay Validation Parameters
Simoa Assay Validation Parameters Lowest Detectable Dose / LLOQ Normal Range Dynamic Range Imprecision Spiked Recovery Linearity Correlation Cross-reactivity Matrix Interferences Stability – Short term storage / Freeze-thaw
Slide 11: Launched Assays (Current Menu)
Launched Assays (Current Menu) LLOQ* LLOQ* Volume Required Biomarker (Serum and (Undiluted Plasma) Samples) Serum or plasma BLC (CXCL-13) 0.64 pg/mL 0.064 pg/mL 60 µL IFN-γ 0.019 pg/mL 0.0095 pg/mL 200 µL IL-1 beta 0.031 pg/mL 0.016 pg/mL 200 µL IL-6 0.091 pg/mL 0.0046 pg/mL 50 µL IL-10 0.037 pg/mL
Slide 12: BLC (CXCL13): RBM Simoa Assay – Validation (1:10)
BLC (CXCL13): RBM Simoa Assay – Validation (1:10) ULOQ: 130pg/mL LLOQ: 0.064 pg/mL 12
Slide 13: BLC: RBM Simoa Assay - Precision
BLC: RBM Simoa Assay - Precision Mean Inter-Run Controls Run #1 Run #2 Run #3 Run #4 Run #5 pg/mL CV Level 1 3.2 4% 5% 13% 18% 10% 12% Level 2 20 8% 9% 11% 4% 11% 10% Level 3 201 4% 16% 6% 0% 10% 11% 13
Slide 14: IL-17A: RBM Simoa Assay - Validation (1:4)
IL-17A: RBM Simoa Assay - Validation (1:4) ULOQ, 120 pg/mL LLOQ, 0.012 pg/mL LDD, 0.029 pg/mL
Slide 15: IL-17A Linearity (Feasibility)
IL-17A Linearity (Feasibility) Results 1:2 Results 1:4 Linearity (pg/mL) (pg/mL) % Recovery Serum 1 0.24 0.14 120% Serum 2 0.57 0.29 103% Serum 3 0.35 0.16 95% Serum 4 0.90 0.49 109% Serum 5 0.49 0.27 110% Serum 6 0.49 0.27 111% Serum 7 0.27 0.14 105% Serum 8 0.16 0.088 111% Plasma 1 0.96 0.54 114%
Slide 16: IL-17A Antibody Competition Assay
IL-17A Antibody Competition Assay Results 1:2 (pg/mL) Results 1:2 (pg/mL) Sample ID No pretreatment Pre-incubated with IL-17A Ab % Recovery Serum 1 0.24 <LOW> 0% Serum 2 0.57 <LOW> 0% Serum 3 0.35 <LOW> 0% Serum 4 0.90 <LOW> 0% Serum 5 0.49 <LOW> 0% Serum 6 0.49 <LOW> 0% Serum 7 0.27 <LOW> 0% Serum
Slide 17: IFN-gamma: RBM Simoa Assay - Validation (1:2)
IFN-gamma: RBM Simoa Assay - Validation (1:2) ULOQ, 20 pg/mL LLOQ, 0.019 pg/mL LDD, 0.019 pg/mL
Slide 18: Assays in Development
MYRIAD @RBM. \ Assays in Development
Slide 19: Assays in Development: Sensitivity
Assays in Development: Sensitivity MRBM Simoa LLOQ* R&D system MDD MRBM Luminex LLOQ* Analyte (pg/mL) (pg/mL) (pg/mL) IL-2 0.065 7.0 8.22 RDS BLC MDD: 1.64pg/mL IL-4 0.031 0.11 6.92 GM-CSF 0.025 0.26 4.20 *LLOQ was calculated without sample dilution factor 19
Slide 20: GM-CSF (1:4)
GM-CSF (1:4) ULOQ: 20pg/mL LLOQ: 0.025 pg/mL 20
Slide 21: Applications
MYRIAD @RBM. Applications 21 INNOVATIVE SOO WT) ON Ss
Slide 22: Rheumatoid Arthritis (RA) v. Normal (IFN-γ)
Rheumatoid Arthritis (RA) v. Normal (IFN-γ) Average Median Min Max Sample Type Sample number (pg/mL) (pg/mL) (pg/mL) (pg/mL) Normal 20 0.135 0.0585 0.0206 1.15 RA 20 0.212 0.0652 0.0081 1.24 22
Slide 23: Rheumatoid Arthritis (RA) v. Normal (IL-1β)
Rheumatoid Arthritis (RA) v. Normal (IL-1β) Average Median Min Max Sample Type Sample number (pg/mL) (pg/mL) (pg/mL) (pg/mL) Normal 19 0.0441 0.0181 0.0045 0.343 RA 20 0.0802 0.0489 0.0051 0.401 23
Slide 24: Rheumatoid Arthritis (RA) v. Normal (TNF-α)
Rheumatoid Arthritis (RA) v. Normal (TNF-α) Average Median Min Max Sample Type Sample number (pg/mL) (pg/mL) (pg/mL) (pg/mL) Normal 20 1.10 1.07 0.635 1.73 RA 20 3.73 1.44 1.01 39.3 24
Slide 25: Summary – Simoa Services
Summary – Simoa Services Extending Our Proven Track Record in Delivering Valuable Pharmacodynamic Immunoassay Data to Ultra- Sensitive Immunoassays Expertise for Innovative Dx Discovery Collaborations & Partnerships Cytokines Acute- Metabolic Hormones Inflammatory Cardio- Oncology Tissue Phase Vascu
Slide 26: Myriad RBM
MYRIAD @RBM.