1. Confidential | 1
Single Molecule Array (Simoa™) for Ultra
High Sensitive Detection of Biomarkers
2. Confidential | 2
Who We Are
Founded in 2007, Quanterix is a leader in high definition diagnostics,
delivering ultrasensitive single molecule measurements for the benefit
of human health.
• Leverages proprietary single molecule array (Simoa™) technology
• Offers ̴1000x sensitivity improvement over current standard
• Proven applications in oncology, neurology, infectious disease, and beyond
3. Confidential | 3
Corporate Overview
• Founded 2007 by David Walt (founder of Illumina) and Nicholas Naclerio
• Exclusive licensee of patent portfolio developed by David Walt at Tufts University
• ̴ 50 employees, 15 Ph.D’s
• Expanded to state-of-the-art 20,000 sq. ft. facility April 2012 in Lexington, MA
• Venture-backed by leading life science investors and strategic partners
• Cumulative $47M Raised in Series A, B, C
4. Confidential | 4
Quanterix is supported by and working with
leading organizations around the world
Investors Partners
Funding Collaborations
6. Confidential | 6
Single Molecule Arrays (Simoa) Provide a Digital Advantage
0 pM 10 pM
• Reaction volume = 100 ×10−6 L
• Diffusion = dilution = low sensitivity
• Millions of molecules needed to reach detection limit
• Reaction volume = 50 ×10−15 L (2 billion times smaller), 50 femtoliters
• Diffusion defeated = single molecule resolution = ultimate sensitivity
• One molecule needed to reach detection limit
Simoa (Digital)
0 aM 3.5 aM 350 aM 3.5 fM
7. Confidential | 7
Step 1. Load Consumables
• Kits
• Cuvettes and disposable tips
• Simoa discs
Step 3. Load Samples
• 96 well plates or tubes
Step 2. Menu Setup
• Select assay
• Calibrators and controls
Step 4. Run Samples
Step 5. Data analysis
• First result in 75 min
Ultra-sensitive with
fully automated
simplicity
Small sample volumes
Open platform
(Homebrew for RUO)
68 test per hour, >500
data points per day
Quanterix Instrument Workflow
8. Confidential | 8
Simoa Disc
• Low-cost consumable
• 24 arrays/disc (4 discs = 96 well
plate)
• 216,000 femtoliter wells per array
• Manufactured using state-of-the
art Blueray™ technology by Sony
DADC
• High volume production easily
scalable 216K wells
9. Confidential | 9
Quanterix Instrument and Assay Features
Metric Quanterix
Throughput • 68 Tests/hour
• >500 data points per day
Workflow • Batch (plates or tubes)
Total Assay Time • <2.5 hours per 96-well plate
Hands on Time • Startup time <20 minutes
• Walkaway time TBD
Automation • Full (sample in to data out)
Sample input • 96-well plates and tubes
Sample volume • 10 ml -100 ml
Instrument Footprint • 135x60x160 cm (freestanding)
Content • 30 Kits at launch
• Homebrew (build your own)
Assay Flexibility • 1, 2 or 3-step assays, incubation time, number of wash steps
Metric Quanterix
Sensitivity • 200 - 1,000 fold better than ELISA
Dynamic range • >4 logs
Precision • <10%
Instrument
Assay
Performance
10. Confidential | 10
Digital ELISA detects proteins in the fg/mL range
Protein
SiMoA LOD
(pg/mL)
Gold Standard
Assay LOD
(pg/mL)
Sensitivity
Fold
Increase
IL-1b 0.001 0.057 R&D Systems 57
TNF-a 0.003 0.106 R&D Systems 35
GM-CSF 0.003 0.26 R&D Systems 87
p24 0.005 5 OCD 1000
IL-6 0.005 0.039 R&D Systems 8
PSA 0.006 10 Roche/Siemens 1667
Ab42 0.02 50 Innotest 2500
tau 0.02 60 Innotest 3000
IL-1a 0.024 1 R&D Systems 42
GLP-1 0.033 11 Luminex 333
p-tau (181 + 231) 0.04 NA NA ND
IL-5 0.049 0.115 R&D Systems 2
Troponin I 0.05 3 Abbott Architect (HS) 60
p-tau-231 0.05 NA NA ND
p-tau-181 0.1 60 Innotest 600
11. Confidential | 11
Simoa Addresses Many Opportunities That Exist for
High Sensitivity Clinical Diagnostics
Infectious Disease
Inflammatory DiseaseOncology
1 mm3 Tumor
BloodBrain
Endothelial Cells
Neurodegenerative Disease
Prenatal Screening
Cardiovascular Disease
Abnormal/
Rare Protein
Simoa allows blood tests for
neurological disorders
Simoa is world’s most sensitive
troponin test
Simoa is first Immunoassay to
be as sensitive to virus as PCR
Simoa first technology to
quantify effect of anti-TNF-a
drugs on target protein
Simoa shortened time for
detection of cancer recurrence
from years to months
12. Confidential | 12
Inflammation
Crohn’s Disease (TNF-a, IL-6) (Mayo Clinic)
• Study Objectives: Measure cytokine levels in normal individuals and patients with clinically
active Crohn’s disease (CDAI>220) undergoing anti-TNFa therapy (e.g. Remicade, Humira,
Enbrel)
• Completed retrospective clinical study on 17 patients.
• Observed significant elevation of IL-6 in plasma from
patients compared to controls. After therapy, the mean
reduction in the concentrations of TNF-a and IL-6 were
46% and 58%, respectively.
• Clinical Utility: Changes in cytokine concentrations after
therapy indicate that measurement using digital ELISA
could be used for monitoring therapeutic efficacy
Song et al., J. Immunol. Methods, 2011, 372, 177-186
0.0
0.5
1.0
1.5
2.0
2.5
3.0
3.5
4.0
4.5
5.0
#1 #3 #5 #11 #13 #17 #19 #25 #27
Case Number
Before treatment with anti-TNF-a
After treatment with anti-TNF-a
TNF-a(pg/mL)
xMAP LOD
Crohn's Disease Healthy
0.01
0.1
1
10
100
[IL-6](pg/mL)
xMAP LOD
Simoa LOD
13. Confidential | 13
Neurology
Brain hypoxia (Ab42, tau) (Univ. of Gothenburg)
• Achieved 2500-3000-fold greater sensitivity than benchmark commercial assays (LOD 10-20
fg/mL). Only test capable of precise measurement of these markers in blood (normally tested
in CSF).
• Completed retrospective clinical study on 25 cardiac arrest patients. Objective: look for
changes in serum levels of these markers as potential early indicators of long term brain
damage.
• Observed, for the first time, Ab42 elevation in live humans
associated with brain ischemia. Suspected significance in
Alzheimer's disease pathogenesis. Strong correlation with 6 month
cognitive outcome. Tau data even stronger.
• Clinical Utility: early prognostic indicators of long term brain
damage.
Zetterberg et al., PLoS ONE 6(12): e28263. doi:10.1371/journal.pone.0028263
good outcome
bad outcome
14. Confidential | 14
AccuPSA(pg/ml)LogScale
0.1
1
10
100
1000
Non-Recurrence Recurrence
Oncology
AccuPSATM (Johns Hopkins, NYU)
• Achieved 1,667-fold greater sensitivity than benchmark commercial assays
(LOD = 6 fg/mL). Only test capable of precise measurement of PSA following
prostatectomy.
• Completed pilot study on utility of the assay to predict recurrence of prostate
cancer after radical prostatectomy from a single blood test.
• Convincingly demonstrated that a single AccuPSA result 3-6 months after
surgery highly predictive of cancer recurrence over five year period.
• Clinical value: ability to target secondary
radiation treatment for higher risk group,
identification of ultra-low risk group for whom
such treatment unnecessary
• Commercial leverage: more accurate treatment
targeting; improved efficacy with earlier
treatment; single test result
• Lepor et al., Br. J. Urol. Int., 2011, 12 OCT 2011, DOI:
10.1111/j.1464-410X.2011.10568.x; Wilson et al., Clin. Chem.,
2011, 57, 1712-1721.
15. Confidential | 15
SimoaTM Benefits
Current Offerings Simoa
Current technologies lack sufficient sensitivity for
many biomarkers
̴ 1000x sensitivity improvement
(femtomolar, 10-15)
Limited dynamic range > 4 logs of dynamic range
Time consuming manual process (3-5 hrs.) Fully automated system – sample in, result out,
save on FTE cost and manual errors
Imprecision High imprecision of results < 10% CVs thanks to digital approach
Large sample size (25-50 microliters) As little at 1 microliter (with dilution)
Acceptable cost/sample Similar costs to current approach, using
conventional reagents
Limited path to Laboratory Developed Tests (LDT)
and IVD
Simoa is very amenable to LDT. Partner in IVD is
bioMerieux
16. Confidential | 16
Using single molecule measurement Simoa
delivers high definition diagnostics. This
remarkable digital sensitivity combined with
full automation unlocks a world of insight into
disease detection, diagnosis, and patient
treatment while meeting the demands of
today’s laboratory.
Thank You
