Automation of novel multi-parameter allergy test that is cost-efficient and delivers instantly correct results

Project Information

AllergyExplorer

Grant agreement ID: 811470

DOI

10.3030/811470

Project closed

EC signature date 10 May 2018

Start date 1 June 2018

End date 31 May 2020

Funded under

• INDUSTRIAL LEADERSHIP - Innovation In SMEs

Total cost

€ 3 536 250,00

EU contribution

€ 2 475 375,00

Coordinated by

MACROARRAY DIAGNOSTICS GMBH
Austria

Periodic Reporting for period 2 - AllergyExplorer (Automation of novel multi-parameter allergy test that is cost-efficient and delivers instantly correct results)

Reporting period: 2019-06-01 to 2020-05-31

Summary of the context and overall objectives of the project

The WHO declared allergy a major health problem of the 21st century. In the past, medical practitioners had to pre-select very few allergens for in-vitro testing, based on prior anamnesis, under time and cost pressure. The consequences for the patients were not optimal treatment and reduced quality of life. For the public health systems more than 140 Bn Euro are spent each year which could be saved if all allergic patients were treated adequately.
We have developed a multi-parameter allergy test covering close to 100% of the globally relevant allergens in a single lab test and have proved that it works in clinical practice. We introduced affordable testing on the molecular level which provides valuable decision points such as enhanced risk assessment, to a level of detail and extent not available before this project. Our allergy test is technically validated and registered as an in-vitro diagnostics device in Europe and many other markets worldwide. So far we have customers in +50 countries in all 5 continents. With full lab automation available as the most valuable outcome of this project, we now target customer segments of highly automated clinical routine labs representing the biggest market segment. We expanded our molecular allergen panel to become the most complete in the market – by far. Our tests include fully integrated interpretation and decision support tools which will facilitate result interpretation by experts and non-experts alike regardless of the complexity of the patients profile. We demonstrated the clinical utility of our approach by generating supportive data to justify a change of the current diagnostic paradigm for the diagnosis of allergies. We upscaled our production capacity by developing automated solutions which increase quality and reduce costs of manufacturing to increase price sensitive market penetration in the future.

Work performed from the beginning of the project to the end of the period covered by the report and main results achieved so far

During this project, we focused on the most important parameters of any innovation-driven diagnostic product supplier: quality, validity, supply and cost of our products and processes.
Our project quality and risk management seamlessly integrated into our overall quality management and quality policy to exceed our customers’ expectations in any dimension relating to our products and services.
Automation and convenience is key for modern laboratory infrastructure and quality of outcome for the patient. Therefore, we developed our manual allergy test into a fully automated one, with the help of one of Europe’s leading OEM manufacturer and our dedicated RnD team. Going hand in hand with assay and software development we managed to bring to market to most complete and advanced allergy test. The AllergyExplorer has more molecular allergen parameters than all market competitors combined – and almost double of that. Many of the diagnostic parameters we developed during this project are clinically relevant and not available from competition. The developed automation platform not only integrates into any modern lab infrastructure, it is also capable of sufficient throughput for even the most demanding labs, while covering the low-cost need of small customers alike. In addition, our software brings all necessary education and training insights for clinicians to allow any medical practitioner to exploit our diagnostic results for the best benefit for the patient. On the go, we collect evidence for research and product development in real-time and without additional costs to patients or health care providers. Our marketing and RnD teams initiated studies to demonstrate the benefit of our tests – clinically, scientifically and socioeconomically. Our manufacturing and engineering teams ramped up production capacity by developing dedicated automation solutions during the project, so we are able serve the fast growing capacity need of our customers and decrease the cost of manufacturing. We will improve the life of allergic patients in the very near future, by eliminating the need to choose between cost or quality in allergy diagnosis – for good.

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)

In our efforts to become the new gold standard for allergy testing, we reached all the goals we aimed for – and beyond that. In less than two years we achieved global market penetration and evidence generation on levels unseen before, and we are still in the infancy of our products and our diagnostic concepts rollout.
While the importance of allergic diseases has been given little media attention in the recent months based on the COVID epidemic, allergies are still a globally important health care problem which causes unnecessary impairments in quality of life, premature death and excessive health care expenditures.
With our current level of business activity, we expect that our tests produce higher number of diagnostics results on a molecular level as all our competitors combined. Yet we are the only company to systematically collect the data and trying to combine them with clinical anamnesis – and if possible, outcome.
We have shown on all levels that comprehensive allergy diagnosis is necessary, can be cost-effective, and if used by properly trained or supported health care personnel, will improve the burden of allergic diseases.

Allergy Explorer (ALEX) test kit including testing equipment

Prototype MADxMAX45k instrument