The ARM-B skin-allergy diagnostics patch is a compact, easy to apply, low-cost allergy testing product.

Project Information

ARM-B

Grant agreement ID: 817194

DOI

10.3030/817194

Project closed

EC signature date 12 May 2018

Start date 1 June 2018

End date 31 August 2018

Funded under

• INDUSTRIAL LEADERSHIP - Innovation In SMEs

Total cost

€ 71 429,00

EU contribution

€ 50 000,00

Coordinated by

ALLOGEN BIOTECH LIMITED
Ireland

Periodic Reporting for period 1 - ARM-B (The ARM-B skin-allergy diagnostics patch is a compact, easy to apply, low-cost allergy testing product.)

Reporting period: 2018-06-01 to 2018-08-31

Summary of the context and overall objectives of the project

"ARM-B (Allergy Registration Microarray Biosensor) represents a leap in allergy diagnostics since ""skin prick"" tests. The test is performed either by a clinician or at home. The user places a patch, containing a micro-needle array onto their skin. Each micro-needle represents a single allergen. The detection processes involves measuring an immunoresponse from the user’s skin. This response is digitised and analysed using a reader or Smartphone.
ARM-B is a follow-on product from Allogen Biotech's allergen detection technology. It exploits significant intellectual property developed by Allogen Biotech in the fields of rapid diagnostics and electrochemistry.
""Skin Prick"" allergy testing is regarded as the most reliable method for allergy diagnosis. The test involves a medical professional placing a small droplet of allergen on the skin and then penetrating the skin so the allergen has a chance to create an immunoresponse. This triggers a localised swelling or hive which is measured to give an allergy severity rating. A major drawback to Skin Prick is time constraint and number of allergens to be tested. ARM-B involves a single-stage patch placement and can detect hundreds of allergens in a matter of minutes.
The ARM-B skin-allergy diagnostics patch is a compact, easy to apply, low-cost allergy testing product. It can provide allergy information in an electronic format. It is highly sensitive (capable of detecting a mild allergic reaction) and offers reliable identification of a wide panel of allergic disorders in a single test.

The worldwide market for allergy diagnostics and therapeutic products and services is over US$25.7bn (2014). The projection for diagnostic tests is set to reach US$5.74bn by 2022, with a rate of growth of 10.5% (CAGR) over a five-year period. Europe leads the market (volume/value) in terms of its use of allergy diagnostics products, constituting just over 50% of this diagnostics sector. US are the second-largest global market and show the highest rate of growth due to the increasing prevalence of inhaled allergies: rates driven by rising incidences of allergic diseases thought to be caused by lifestyle choices and environmental impacts.

Much of this value and growth is accounted by skin allergy tests (CAGR 8.2%, 2023), where consultation costs is typically $200 to $300, compared to antibody blood test $500 to $1000. Allogen Biotech’s technical expertise in biosensor development for diagnostics and commercial understanding of the allergy test market positions the company uniquely to exploit the technological advances ARM-B offers.
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Work performed from the beginning of the project to the end of the period covered by the report and main results achieved so far

"Size the reachable customers and a reliable market share
Establish a sound ""Go-To""Market"" Strategy
Accomplish 5 years financial projections
Risk Assessment and Contingency Plan
Define a minimum viable product to be first marketed
Scout and Identify industrial partners in the supply/value chain

• There is a clear market for ARM-B
• The market has many segments which will provide opportunities for ARM-B
• Little Intellectual Property has been filed for allergy diagnostics using microneedle arrays and smart sensors. This suggests the ARM-B launch will be timed well and into a market place that needs a leap in technological advancement.
• Allogen Biotech is short on several personnel needed for the ARM-B project, but we have begun interviewing for positions and managers
• A key area of difficulty will be the supply chain and its management. Building a consortium that includes a member with a supply chain fit for our needs will be important.
• There are technical difficulties unforeseen at the beginning of the project that will need to be addressed. These include the coating of the microneedles in individual allergens, the manufacturing cost of each array, and the packaging/storage of the ARM-B strips. It is envisaged these difficulties will be address before the Phase 2 proposal is submitted in April 2019.

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Progress beyond the state of the art and expected potential impact (including the socio-economic impact and the wider societal implications of the project so far)

ARM-B aims to deliver allergy diagnostics to the end user with a synergy between different technologies unseen before in medical diagnostics. ARM-B will build on the knowledge gained during the project to further develop an understanding of the market players, the fringe segments, technology limitations, and exploitable opportunities in the marketplace.
By the end of the project a full Phase 2 proposal will be written and submitted to H2020 for the April 2019 call. The main potential impact of this will be a funding mechanism to realise the potential technology of ARM-B and provide an innovative solution to allergy diagnostics. Allogen Biotech’s innovation advances traditional skin-prick tests, where an allergy clinician individually injects allergen formulation into the skin of a patient and observes and measures colour charts and size of hives after 15-20 minutes. Interpretation of the results can only be achieved by those clinically trained. ARM-B allows reliable skin allergy testing to be performed with a stick-on patch worn by a patient for a few minutes. The technology is non-intrusive for the patient, simple to apply for the allergy analyst. ARM-B is a child-friendly allergy diagnostics system, no nasty shocks, pain or crying. The microarray feature of the technology allows the clinical practice to test many more suspect allergens in one consultation. Test results on tens or even hundreds of allergies are available in 5 minutes. Allergy data and information displayed at a PC or other remote device. Allergy test results will list allergen panels, with individual biosensors electronically reporting allergy reaction levels numerically in terms of degree of severity. Spreadsheet data and graphical presented by an allergy diagnostics user interface. As with the traditional skin-prick test, the allergy clinician would consult the patient on test outcome – the clinical meaning of the results and advise on any further testing and treatments. The ARM-B would identify quickly the source of the most troublesome and complex allergy diseases, viz hay fever, food allergies, atopic dermatitis, allergic asthma, and anaphylaxis

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