Although less than ten years old, the German-based company Aesku.Diagnostics has been making a big name for itself in the field of autoimmunity in general and in in vitro autoimmune diagnostics in particular. This has culminated in the company being awarded the prestigious Frost and Sullivan 2008 European Autoimmune Disease Diagnostics Product Line Strategy Award. We wanted to find out more about Aesku, how they won the award and generally what makes them tick. We spoke to Dr Torsten Matthias, founder, owner and managing director of Aesku.Diagnostics.
Q: Your company has an intriguing name. What’s behind it and what are your company’s roots and history?
A: Our name is simply a reference to Asclepius, the ancient Greek god of medicine and healing, together with the field in which we’re active, namely “diagnostics”. However, there is actually much more to us than just diagnostics. Just as Asclepius had several daughters symbolising different subsets of good health, Aesku.Diagnostics has a number of “daughter” activities, principally in all the various fields of autoimmunity. It was clear to us from the outset that a challenging field such as autoimmunity would require a unique approach so an interdisciplinary network was created to combine research, diagnostics and therapy under the same umbrella.
Thus, Aesku is a group of companies that includes Aesku.Diagnostics (Autoimmunity IVD), Aesku.Therapy (Autoimmune Therapies) and Aesku.Systems (Lab automation) as well as Aesku.Inc, our subsidiary in the US. In addition we support the Aesku.Kipp Institute, a non-profit organisation primarily involved in research on the molecular mechanisms of a number of autoimmune diseases.
Despite being in existence for only nine years, Aesku.Diagnostics holds several patents and is highly regarded in the autoimmune diagnostics market in more than 80 countries. With over 140 different products in autoimmune diagnostics, we are considered as one of the European market leaders in the field.
Q: Congratulations on being awarded the Frost and Sullivan “2008 European Autoimmune Disease Diagnostics Product Line Strategy Award”. Could you explain exactly what this strategy is and what are your flagship products?
A: We have two main types of products, namely our enzyme-linked immunosorbent assays (ELISA) kits (marketed under the AESKULISA brand name) and immunofluorescence slide panels (marketed under the AESKUSLIDES brand). The ELISAs are more popular in autoimmune diagnosis; we have more than 100 CE-marked kits incorporating human recombinant antigens that are synthesised in-house to assure maximum sensitivity and specificity. The kits are used in rheumatology, thrombosis, gastroenterology, vasculitis, thyroid, diabetes, hepatology and other rare autoimmune pathologies. Our newly introduced 30-30-30 test format is compliant with most commercially available automated test platforms.
Right from the start we were aware of the importance of automation in the autoimmunity lab and so focused our research efforts on producing a universal product protocol that would be compatible with both automated and manual assay formats. Known as ‘THE ONE’ Aesku concept, this involves one working protocol, one pre-dilution ratio, one buffer system, one reagent system, one calibration range, one cut-off and one assay platform for all Aesku tests. This clearly improves lab throughput and reduces diagnosis time.
As for the immunofluorescence slides, these cover a broad range of tests and, like all our other assay systems, even they have a single universal protocol and a pre-set pipetting protocol.
Nowadays, a tender from a potential purchaser can almost never be completely satisfied if the manufacturer doesn’t offer automation possibilities for the tests; reagent rental contracts are the most common financial model to support the costs of such automation and instrumentation. For these reasons we decided to develop HELMED, an automatic flexible processor system capable of running and managing routine tests for autoimmunity and infectious serology in the lab.
Our company has always had the policy of providing customers with uninterrupted services, including innovative features such as our “second opinion lab service”, which gives customers free help on sample diagnosis questions. From its inception in 2000, Aesku.Diagnostics has always focused on the development of robust and autoimmune disease specific diagnostic kits. We have diversified our product portfolio and our company structure consequently emphasising equal importance to all the major disease sectors under the autoimmune disease space.
The HELMED project together with the Aesku “ONE” concept gives the company the tools and arguments to consolidate sales in mature markets, increase market shares in developing markets and have full control of the automation aspect, that is vital for the future of the business.
Q: The Frost and Sullivan award is presented to the company that has “demonstrated the most insight into customer needs and product demands”. How does your company effectively discern customer needs?
A: Besides the usual requests of our quality management system for continuous research and development to satisfy customer requests and market trends, we definitely do a little more to stay in direct contact with potential users.
For example, one great advantage of the customer support services mentioned above is that not only do they help our customers to be more efficient, but they also give us the opportunity to get a great insight into real life out there in the labs. Close contact and collaborative development projects with numerous recognised scientists in the autoimmunity field and also with experienced clinicians and established labs allow us to translate latest research findings into new products.
Q: In the past some people considered autoimmune diagnostics as a ‘niche’ market. Is this attitude changing, and if so why?
A: With one in twenty people in the general population being affected by one (or several) of 80 currently known autoimmune conditions, it’s actually surprising that autoimmune diagnostics should have ever been thought of as a ‘niche’ market. The problem was that although the number of recognised autoimmune diseases and the number of people suffering from them are high and have been growing steadily for years, the actual market didn’t actually grow correspondingly simply because there was a massive knowledge “gap” in the field.
Now over the last few years we can see an explosive increase in awareness of the impact that autoimmune diseases have on overall healthcare costs. This, together with recent research that shows convincingly that efficient therapeutic options exist in autoimmunity, provided there is an early and accurate diagnosis, has greatly stimulated interest in such early diagnosis — or even prognosis — systems for autoimmune conditions. All this has of course triggered the market for in vitro autoimmune diagnostics.
In addition, easy-to-use assays and advanced automation technologies such as those from Aesku have changed the field of autoimmune diagnostics from its old image of being somehow “esoteric” or “tricky” to one of reliable routine.
A very good example of this change in perception is “The One Concept”. First of all it allows customers to carry out safe, easy and efficient autoimmune diagnostics on a routine basis; secondly however it also creates interest on the part of larger diagnostic companies since it gives them the chance to implement autoimmune diagnostics on their instruments and automates.
Q: Indeed, some of these big players in clinical diagnostics have been adding autoimmunity diagnostics to their test menus, as well as taking over smaller companies. Do you view this as a threat or an opportunity? Why?
A: It’s a challenge! Our experience shows clearly that you need expert knowledge to be able to react quickly to changing customer needs or to rapidly transform new autoimmunity research findings into practical and cost-efficient test systems.
We are therefore convinced that our strategy, including as it does a clear focus, an extensive expert network in R&D and a comprehensive product portfolio complemented by innovative services puts us in a strong market position. Our expertise in autoimmunity makes us a valuable R&D partner (also a distribution partner) particularly for big players in clinical diagnostics. Up to now such big companies still offer only a relatively small portfolio in autoimmune diagnostics, even after sometimes having taken over hole companies.
Receiving the Frost & Sullivan award in competition against several big names clearly motivates us to continue our strategy of taking responsibility for all value steps in assay development and so providing an overall analysis platform for autoimmune diseases.
Q: In this time of economic crisis and recession, how do you see the future of the European IVD industry in general, and Aesku’s future in particular?
A: My guess is that, as confirmed by a recently published F & S report, our market is overall less likely than many other industries to be drastically affected by the current economic downturn. Unless there are major changes to test prices and reimbursement policies, it can be expected that, over the next few years the market will maintain its steady growth rate since routine test volumes are unlikely to be significantly affected.
We estimate that the IFA and ELISA autoimmunity markets will continue to grow in the upcoming years, whereas tests which are funded by out-of-pocket payments are likely to take a hit. New expensive technologies such as multiplex assays might have a growth stagnation due to cost limitations. That’s why we see a lot of opportunities for the Helmed and the ELISA/IFA consolidation in the current
market situation.
The F & S report that I mentioned previously points out that the diagnostics business in general is in late stage growth with innovation being a key factor to propel its escalation. By focusing our R&D on earlier disease detection and more advanced automation or even on tests that can predict patient outcomes, we will contribute to significant healthcare cost savings and perhaps even allow targeted medicine. New exciting R&D projects with potential to deliver considerable growth have already been identified.
We are ready for future growth!
