The Viennese biotech company Macro Array Diagnostics was only set up in 2016, but has already launched a product successfully. The ready-to-use "Allergy Explorer" ("ALEX" for short) is widely used. The new method behind it allows for the quick diagnosis of allergies.
Standards have played an important role in product development right from the start. And the success story continues: Recently, the start-up was able to obtain substantial funding within the framework of Horizon 2020.
Help for allergy sufferers
Macro Array Diagnostics' objective is to improve decisively the lives of allergy sufferers. The start-up that specializes in allergy diagnostics was established by Christian Harwanegg, Georg Mitterer and the business angel Christian S. Dennstedt. Within a very short time, an innovative multi-parameter allergy test was developed.
The "Allergy Explorer" ("ALEX") uses a single drop of blood plasma or serum to obtain a comprehensive antibody profile and tests for 300 different allergens at the same time. As a result, the patients do not have to undergo the unpleasant procedure of the skin prick test.
"ALEX covers all known allergens. This diagnosis provides great added value to the patients. We can differentiate everything exactly. For example, it is possible to identify the allergens in egg yolk and egg white to which the patients respond. This helps them with regard to the choice of food because they know, for instance, whether they tolerate heated egg white or not," microbiologist and CEO Christian Harwanegg describes the revolutionary new method.
ALEX includes all the components required for rapid allergy testing. The results can be analyzed by software. Since the product's launch in August 2017, Macro Array Diagnostics has taken off internationally. The ready-to-use kit is used in laboratories in Austria, Switzerland and Italy. The next focus is on other EU countries. In addition, there is research-based co-operation with Canada.
At the right time: the start-up package of Austrian Standards
The application of international standards is a matter of course for the start-up. During product development they already thought ahead and reflected on the issues to be taken into account to meet the requirements of ISO 13485.
"ISO 13485 is the international standard allowing the manufacturers of medical products to demonstrate that they have an effective quality management system. The standard helped us getting to market faster. We can enter new markets more easily and it simplifies matters for everyone – for customers and suppliers alike," explains Birgit Weißenböck, Head of Quality Management and Regulatory Affairs at Macro Array Diagnostics.
The quality management system is even certified according to ISO 13485. "For us, as a start-up with limited resources, the start-up package offered by Austrian Standards came at exactly the right time," she adds. Tailored to the needs of start-ups, Austrian Standards' start-up package provides special benefits: discounts or access to an international network for gaining know-how.
Standards mean much more than just compliance with regulatory requirements for Macro Array Diagnostics. They help eliminate the need for re-inventing the wheel and give orientation. Especially in the beginning, this may be the key to reducing time to market for a start-up.
Birgit Weißenböck recommends: "It is important to define the intended use of a product early on and to decide on the countries where it should be put on the market. In internal co-ordination, feasibility should be tested as early as possible –– with all the relevant employees. A cross-departmental perspective contributes to using the recommendations of a standard in such a way that the project profits."
At present, the start-up is just a user of standards, but they think about actively shaping standards as well. Technical discussions with other experts active in this field can help Macro Array Diagnostics to make further progress.
And there is every sign for future growth. in addition to winning various awards, the start-up recently received a contract under the EU's Horizon 2020 programme. The funding to be provided is 2.5 million euro – more than to any other Austrian company to date.
More about the start-up package of Austrian Standards: www.austrian-standards.at/startup
ISO 13485 Medical devices - Quality management systems - Requirements for regulatory purposes
ÖVE/ÖNORM EN ISO 13485 Medizinprodukte - Qualitätsmanagementsysteme - Anforderungen für regulatorische Zwecke