We will transform our industry

with INNOVATION, improve

public health while reducing
health care expenditures
Shukur Ullah
By
CEO, MADx

www.macroarraydx.com 1
 MADx – Macro Array
Diagnostics
 Foundation 2016

 Based in Vienna, Austria

 Private company with public

funding

 20 employees, 150 years of allergy know how

 IVD Manufacturing, focus on allergy

 ISO 13485 & 9001 certification since June 2017

 Market entry with CE marked IVD product in August

2017

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We make the most innovative test for
allergy
MISSION MARKET & CLIENTS COMPETITION
Our offering is targeted for: Unlike
CHANGING THE GAME • Any other product on the market
• Medical professionals in patient
WITH INNOVATION
care, research or pharmaceutical
industry Our product
• Delivers a complete and precise
who diagnosis
OUR PRODUCT: The most • Need comprehensive and high • for every individual patient
advanced and complete allergy test resolution diagnostic tools to make • Allows personalized precision
available on the market the best decision on treatment & medicine to become the new
therapy gold standard in allergy
treatment
Reducing direct and indirect cost for
this global health problem
TECHNOLOGY
Improving patients quality of life A combination of immunology, nanotechnology, molecular diagnostics and
tools for interpretation and guidance

Company Purpose 3
Problem / Opportunity in Allergy
Impact of diagnostics

The European parliament interest group on allergy and asthma has identified key societal
problems
http://www.eaaci.org/documents/Brochure_EP_Interest_Group-April_2017.pdf
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Allergy testing

Today Future

trend
99% Skin test
10% Blood test Paradigm
1% Provocation change 100% Blood test
Confirmative anamnesis
10% Skin test
< 1% Provocation

? % Optimal therapy 99% Individual therapy

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Atopy and the allergic march

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Principle of ALEX

• ALEX is a solid-phase immunoassay

• 283 test results
• Allergen extracts or molecular
allergens
• Balanced allergy panel
• Inhalative allergens
• Food allergens
• Insect venoms
• Latex
• Comprehensive view of a patient’s
sensitization status

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 Product
ALEX eliminates the trade-off between COST and QUALITY of allergy
diagnosis
Features
• Patent-pending combination of
Experience
• CE marked IVD kit including
nanotechnology and multiplex
all reagents and accessories,
immunoassays
ready to use, 12M shelf-life
• State-of-the-art performance
• One product replaces > 700
• > 98 % concordance with reference
products
methods
• > 99 % coverage of all routine
• quantitative results for specific IgE
clinical testing needs
• Almost 300 allergens + total IgE on
each test Benefits • No pre-selection of test

• Near complete allergen panel parameters

• Most comprehensive molecular panel • Saves time during anamnesis,

test available lab processing and

• Minute serum volume required (100 administration

microliter) • Full automation and lab

• The only routine product with CCD integration will be available

Inhibition integrated early 2020

• High specificity, 80 % less false • On-demand selection for non-

positive results screening applications (@flat

• Prediction of cross-reactions between rate cost) www.macroarraydx.com 10

allergens • Automatic interpretation and
 Feature comparison ALEX :
ImmunoCAP ISAC
Parameter ALEX® ImmunoCAP®ISAC Comment/Source of info
Manufacturer Macro Array Diagnostics Thermo Fisher Scientific
Kit size 20 patient samples 19 patient samples + 1 calibration sample DfU
Allergen components (#) 126 112 DfU
Allergen extracts (complete allergens) (#) 156 0 DfU
Serum volume required per sample 100 µl 35 µl DfU
Assay time 4 hours 4 hours DfU
Signal generation Colourimetric, enzymatic signal amplification Fluorescence, no signal amplification DfU
Limit of detection, sIgE for allergen components ≥ 0.3 kUA/L ≥ 0.3 ISU DfU
Limit of detection, sIgE for allergen extracts ≥ 0.3 kUA/L not available -
Limit of detection, tIgE 1 kU/L not available -
Measuring range, sIgE 0.3 - 50 kUA/L 0.3 - 100 ISU DfU
Total IgE Measurement Inlcuded not available -
Total IgE Measuring range 1 - 2.500 kU/L not available -
Readout CCD camera Confocal Laser Scanner BioCapital Scanner Manual
Scanning duration/operation < 2 seconds for 1 test 30 seconds for 1 test ISAC Software Manual
Result analysis Fully automated analysis, manual control Semi-automated analysis, manual control ISAC Software Manual
Minimum samples per run 1 4 Product design
Maximum samples per run (1 operator, 1 day) 96 160 personal experience
Calibration Integrated on every array 1 test of every ISAC kit needed for calibration, heterologous DfU
Allergen or batch specific correction Data Matrix barcode based None Product design
Automation Manual Manual Product design
Storage of processed test before readout 3 Months (if protected from light) Not stated in product characteristics file -
Test results Quantitative kUA/L Arbitrary units; semi-quantitative DfU
Precision (CV, total) < 20 % 25 % > 1 ISU, >> 25 % < 1 ISU DfU
Array Stability 1 year, unopend 1 year, unopend stated on kit
Sample type Serum, plasma (no EDTA) Serum, plasma (no EDTA) DfU
Hemolytic sample interference No No DfU
Total IgE interference Not measureable < 3.000 kU/L tIgE Not measureable < 10.000 kU/L tIgE Product characteristics files
CCD Inhibition yes no -
Software adujustment of allergen panel(s) yes no -
Reagents ready to use ready to use, washing solution has to ordered separately DfU
How to guide online (youtube) offline, paper/pdf only -

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Innovation in Allergy diagnosis

In vivo In vitro Molecular Multiplex ALEX

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Allergen source, allergen extract,
allergen
Allergen source Allergen extract Allergen = molecular
allergen
IgE

Mast cell with

histamine

Allergen producer Mixture of Sensitizing molecule,

allergenic and non- capable of inducing
(e.g. mite faeces) allergenic proteins histamine release

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 Molecular Allergology – diagnostic impact

Extract-based Diagnosis Diagnosis with molecular allergens

• Proper risk assessment not possible • Risk assessment much more precise – threat
of anaphylaxis yes/no?
• Poor resolution of cross-reactivities
• Complete resolution of cross reactivities
• Choosing the right specific immuno-therapy possible
(SIT), more difficult due to poor resolution of
cross-reactivities • Targeted use of SIT
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ALEX Product

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ALEX Technology
• EP Patent was filed March 2016
• PCT/EP2017/057481 was renewed this year
• The patent was published September 2017
• Nationalization phase from 2018

1 mm

Mite

Birch

Cat
Two-step test manufacturing

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Assay principle
Preparation Step 1 Washing

Serum Wash unbound

Blood collection and incubation antibodies away
serum preparation 120 min 3x 5 min

Step 2 Washing Step Step 3 Analysis

Detection- Wash unbound Enzymatic Image acquisition,

antibody detection antibodies (color)-reaction analysis and report
30 min away 5 x 5 min 5-10 min ˂ 1 min

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CCD antibody blocking efficiency
• One of the key features of ALEX
Test performed w/o CCD
inhibitor

Test performed with

CCD inhibitor

Hemmer et al., (2081) Journal of Allergy and Clinical Immunology Volume 141, Issue 1

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 II. Near CCD-free allergy
diagnosis
• IgE antibodies directed against CCDs are clinically
irrelevant, but lead to results of extract based tests(&some
molecular allergens) that are falsely elevated
• ALEX is the only test that offers automatic blocking of CCD
antibodies (=higher specificity)!
• In other systems an extra incubation step is required
Left: examples of an ALEX study
performed with random CCD positive
samples. Results can be completely
blocked, in other test systems a
falsely positive result will occur

Right: example of an ALEX test of

the same sample without CCD blocking
(upper picture) and with the
standard ALEX CCD blocking reagent.
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 Thank you for
your attention!

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