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Simoa Accelerator Laboratory

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Presentation on theme: "Simoa Accelerator Laboratory"— Presentation transcript:

1 Simoa Accelerator Laboratory
Innovation Center for Biomarker Research and Custom Assay Development

2 Simoa HD-1 Analyzer Unprecedented ultrasensitivity
Full automation – sample in to result out; save on FTE cost and manual errors Throughput >500 samples per shift Excellent precision due to digital approach Wide dynamic range Easy & cost-effective implementation Multiplexing capability with small sample volumes Homebrew capabilities with open platform Available for RUO

3 Ultrasensitive Simoa Assays
Tau IL-17a Troponin Broad menu of ultrasensitive singleplex and multiplex assays Well validated assays for biomarkers important in multiple applications areas including oncology, neurology, inflammation, infectious and cardiovascular disease, signal transduction, metabolism Important publications demonstrating analytical assay performance of Simoa and clinical utility of biomarker measurements

4 Simoa Accelerator Laboratory Capabilities
Work directly with Quanterix scientists or send reagents/samples Develop ultrasensitive prototype assays using homebrew kit on HD-1 analyzer. Further optimization and validation of prototype assays available Testing capabilities from a single plate of samples to several thousand specimens to support large clinical studies Expand applications work (e.g. evaluation of new sample types). Matrices tested include: serum and plasma, CSF, urine, tears, tissue extracts, cell or IVF culture supernatant, blood spots – Guthrie cards

5 Developing a Prototype Simoa Assay in Several Days
Day 1: Basic training and homebrew assay reagent development Introduction to Simoa technology and the HD-1 Analyzer Conjugation of beads with capture antibody Biotinylation of detector antibody Day 2: Initial runs of prototype assay Evaluation of initial conditions for LOD determination Selection of optimal bead coating and biotinylation levels Optimize detector antibody and substrate concentrations Day 3: Assessment of matrix and background Final rounds of assay optimization (e.g. 2-step vs. 3-step, buffers etc.) Spike recovery and dilutional linearity Day 4: Sample testing Test a plate of individual samples using optimized prototype conditions Proprietary or commercially available reagents On-site or remote options available

6 Custom Development Options
Feasibility Testing Prototype Dev. Assay Optimization Assay Validation Assay Feasibility Testing and Prototype Development Quanterix will help identify antibody sources and standards Screen up to 3 antibodies (includes antibody-flip for total of 6 combinations) Select the best antibody pair for prototype development Assay Optimization Following development of a prototype assay, Quanterix scientists will expand optimization strategies to further improve assay performance for sample testing Assay Validation Following optimization of an assay, assay validation will be performed. The project scope will be reviewed to define expected outcomes and timelines

7 Sample Accelerator Success Stories
Average sensitivity improvements of ~ 100 fold in only a couple of days using the Quanterix Homebrew Assay Kit Ultrasensitive assays developed for challenging oligomeric or post- translationally modified protein isoforms Detection of cytokines from urine, tissue extracts and dried blood spots after completing internal validation studies Evaluation of small volumes of IVF embryo supernatant to assess biomarker profiles and correlation with implantation outcomes Homebrew kit can be adjusted for detection of bispecific antibodies. Simoa as a tool for PK/PD studies

8 Example of Homebrew Result
100 Partner LOD 92 pg/ml Utilizing Homebrew, a Simoa assay to a colorectal cancer biomarker was developed that was 1300x more sensitive than ELISA assay Endogenous protein was detectable in 19/20 samples 10 pg/ml 1 0.1 Simoa LOD 0.069 pg/ml Plasma Samples

9 Simoa Detects Changes in Serum IL-6 with Compound vs Placebo
Change in IL-6 levels as a function of treatment including placebo and compound 3.5 g/d dose group, adjusting for baseline

10 Ultrasensitive Troponin I Assay for Chest Pain Patients with no Evidence of TnI Using a Conventional Assay Simoa TnI assay has the highest analytical sensitivity of all commercial assays and may be the best in the establishment of a baseline level for any given subject Wu AHB and van Wijk XMR. Clin Biochemistry 2014

11 HD-1: One Platform, a Continuous Spectrum of Value
RUO IUO IVD Clinical IVD Academic Research Pharma/ BioPharma Clinical CRO Blood Sreening CDx Novel Markers LDTs Biothreat Single Molecule Sensitivity – Multiplexing – Full Automation - Workflow Efficiency - Cost Food Safety

12 Quanterix Simoa Accelerator Laboratory
Work with Quanterix to define your interests and requirements Contact to discuss your specific project

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