Simoa Accelerator LaboratoryInnovation Center for Biomarker Research and Custom Assay Development

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

Ultrasensitive Simoa Assays

• 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

Tau

IL-17a

Troponin

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

Developing a Prototype Simoa Assay in Several Days

• Proprietary or commercially available reagents

• On-site or remote options available

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 antibodyDay 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

Custom Development Options

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

Prototype Dev. Assay Optimization Assay ValidationFeasibility Testing

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

Example of Homebrew Result

• 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

100

10

1

0.1

Partner LOD 92 pg/ml

Simoa LOD0.069 pg/ml

Plasma Samples

pg/m

l

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

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

0.0 0.3 0.7 1.0 1.3 1.7 2.0 2.3 2.7 3.0 3.3 3.7 4.0

0

1

2

3

4

5

6

cTnI: ng/L

Fre

quen

cy

HD-1: One Platform, a Continuous Spectrum of Value

Novel Markers

AcademicResearch

Pharma/BioPharma

ClinicalCRO

RUO IUO IVD

Single Molecule Sensitivity – Multiplexing – Full Automation - Workflow Efficiency - Cost

ClinicalIVD

Blood Sreening

CDx

FoodSafety

LDTs

Biothreat

Quanterix Simoa Accelerator Laboratory

• Work with Quanterix to define your interests and requirements• Contact sales@quanterix.com to discuss your specific project