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30 years of DiaSys Diagnostic Systems

This year marks the 30th anniversary of the founding of DiaSys Diagnostics Systems. CLI chatted to Dr Günther Gorka, Chief Executive Officer and Founder, about the company’s story and innovations.

I see that 2021 marks 30 since the founding of DiaSys – congratulations! Can you tell me how the company into being?

Thank you first for the congratulations, 30 years is quite some time. So how did we come into being? Dr Manfred Probst and I were working for another company at their production site in Ireland, and one stormy night there, we came to the conclusion that, because there were some things that we wanted to do differently, we wanted to try to create our own company. Then we looked for partners and we found a third partner here in Germany for distribution in Germany and Austria and he was interested in having turbidimetric assays (homogeneous immunoassays), which are now a very important part of our portfolio. The other company was really not interested in these kind of assays, so I thought that’s nice, we are not going to be in conflict with them in any way. We started to look for a place and we ended up in the garage of our third partner, in Flacht [Rhineland-Palatinate, Germany], near to where we are now. It was a big garage of 100 square metres and several rooms, but it was a garage nevertheless, with parking for a car, but it was good for our needs at the time.

What does DiaSys specialize in?

As well as developing turbidimetric assays, our idea was also to create liquid ready-to-use reagents, which was not normal at the time. We had made a business plan, which allowed for a big loss in the first two or three years, because we wanted first to develop things and that takes some time. After a few weeks of starting, our third partner came to see us and said that he was purchasing two assays from another company that had worked well but now there is a problem with the stability of the reagents and could we do anything to help with this. These were typical clinical chemistry assays – alkaline phosphatase (AP) and gamma-GT [gammaglutamyl transferase] – but we found a solution for him in a couple of weeks and so four months after creating the company we had our first products, which 30 years later are still valid and working without any significant changes. We expanded our product portfolio more and more, but all with liquid ready-to-use reagents and, for the first few years, that was really the driving force of our range because they were so much easier for our customers to use and so much more stable than the reagents that they were used to using. Previously, the reagents were normally freeze-dried powders or a granulate that had to be reconstituted with water or buffers and were often only stable for a couple of hours or a couple of days, whereas our reagents were stable for at least a year, and later on for almost two years. Of course the difference was evident and that was how we came into business and that really is how we created our first successes and a good standing in the market.

At the time, there was one company in the USA that claimed to have similar reagents but they had to use organic solvents to create the long-term stability, whereas we managed to do it with aqueous solutions – only water and the normal ingredients plus some stabilizers. Organic solvents in clinical laboratories always cause problems – there is more evaporation, higher viscosity and therefore the handling is more difficult than with aqueous solutions, etc. So I am proud to say that we were really the first to develop these reagents on purely an aqueous base, so that was really the basis for our success.

How has the company’s product portfolio expanded since then?

Following our initial success with gamma-GT and AP we wanted to find a method for stabilizing NADH in aqueous solution, which was always difficult because usually many interfering compounds were created when NADH was stored for a longer time. We found a way to do it and so then we progressed step by step in clinical chemistry, developing a portfolio of all the routine products as well as some specialized ones, not only for enzyme activity but also for substrate determination, such as the lipids, urea, uric acid, etc. – there are many things that can be measured in serum and plasma

After four or five years of developing many of these reagents, we went back to immunoturbidimetry and then in 1997 we created our first three reagents for apo-lipoproteins and CRP [C-reactive protein] and we expanded this portfolio to more than 20 parameters; in clinical chemistry we are now up to 47 or 48 parameters that we have available.

Then, at the end of the 1990s, we found that our customers had a need for analysers – not only reagents – so we wanted to create analytical devices for our customers. We searched for a long time for the right analyser, but eventually we decided that we would have to try to develop one. So in 2006 we started a cooperation with an Indian company. At the same time, we also acquired the assets and the main people from an insolvency in France and we created DiaSys Technologies, which is now our core for developing our own analysers. Therefore, we used a two-pronged approach and we have now four instruments capable of 100, 200, 400 and 1200 routine tests. At this moment, we are heavily involved in the development of a new type of platform that will perform different technologies, such as photometry and also heterogeneous immunoassays, coagulation assays and ion-selective electrodes for determination of ions – sodium, potassium, chloride, calcium, magnesium, etc.

And that was our second large step, to develop into a systems, and we are happy now with the analysers that we are producing and we have seen in the last few months that, although the pandemic is not over, demand is returning now and people are catching up with the things that they didn’t do over the last 18 months

The past 18 months of global pandemic have been challenging for everyone. How has DiaSys reacted and adapted to the situation?

We have suffered with the pandemic, I must say. We had to adapt and use the Kurzarbeit [Short-time work] scheme, which we used in different areas to different extent from May 2020 until January 2021. Our portfolio consist of products mainly for routine diagnostics and these activities decreased, either because labs were closed or patients were not going to the doctor because of fear of infection with SARS-CoV-2. From autumn 2020, we introduced our first COVID-19 diagnostics, which were rapid tests for antigen and antibody determination. The antigen test was quite well accepted, we bought it in from an external source as we don’t produce rapid tests ourselves, and with the waves of infection we had waves of demand.

Additionally we have developed our own antibody test as we are still convinced that this will become more and more important to measure vaccination efficacy and to assess the need for booster jabs. The assay that we developed is an immunoturbidimetric test with the advantage that this test can be used in almost every medical lab. The other immunological tests that are available work specifically on the platforms that those manufacturers have brought to market. First we produced a test to detect infection, which measures moderate antibody titres. Now, after vaccination, we have individuals with very high antibody titres, especially after the second vaccination. There is also quite a different level of response depending on the type of vaccine used, so we had to improve the test and extend the measurement range. We are still doing research and development to improve it further. We have had some good results so far, but we are now looking to make it comply with the World Health Organization standard ( publications/m/item/WHO-BS-2020.2403), and we are looking to have this standardized test on the market in the next two to three months.

Does DiaSys do all of its own research and development or do you also foster links with academia and the wider community?

In the area of diagnostics you are really obliged to have links to academia, universities and research institutions who can support certain areas and we have those links. We are lucky enough that our Head of R&D (Dr Matthias Grimmler) is also a professor at the Hochschule Fresenius (a university of applied sciences) around 30km from here. This allows us take students to do their Bachelor’s or Master’s theses in our facilities on themes that are also useful and helpful for our own research. Plus of course we have many links to universities here in Germany and France and also other countries to some extent too. We have an especially good relationship with the University of Montpellier in France, the Universities of Düsseldorf and Essen here in Germany, and also in Leipzig and Munich. Additionally we also offer apprenticeships for school students in the area and they learn a bit about the natural sciences, the MINT subjects (maths, information technology, natural sciences and technology) and sometimes someone who has done one of these apprenticeships later applies for a job within the company, which is great!

What is the ethos of the company and how does this contribute to its success?

I am pleased to say that the principle that underlies the company is that we care for each other within the company and also for our people in the wider community. This was typified by one of our third party distributors who was on a cycling holiday in the Ahr valley but stopped his holiday to help the inhabitants who had lost everything when the dreadful recent flooding happened. Additionally, as a company, we have been happy to help both with a financial donation and also practically with a donation of bags that were then filled with provisions for people whose lives and houses have been totally destroyed and now have nothing.

What are some of the current challenges that the diagnostics industry is facing and what do you envisage for its future?

For some time now, we have seen the separation of diagnostics into two areas. One is the growth of large reference labs with big machines and automation that analyse, for example, 200 000 samples overnight.

The other growth area is in point-of-care diagnostics with small instruments, that are easy to use to do assays that either need to be done very quickly or which make sense to be done by the patients themselves, or that are useful for hospitals for monitoring patients with long-term conditions such as diabetes or other areas. These devices will be good for this ‘day-to-day business’ and also for rural areas, of which there are many in the world. So what we are developing at the moment is this ‘combination’ analyser that contains different technologies to cover all aspects of hematology in one instrument, so that all the information needed to make treatment decisions for a patient, particularly in an emergency, can be gained quickly. We have had some success in this already and are hoping to bring a product to market in 2024.

We are also developing our portfolio of reagents with an emphasis on sepsis, where there is still a need for analysis of further parameters in order to be better able to treat this condition. Sepsis is still one of the most life-threatening conditions that is difficult for a doctor to assess, so more tools to improve lab diagnostics would help.

Congratulations again and thank you for your time, do you have any final comments?

I think it will be important for the future to have companies of our size, lets say below 100 million sales, because often innovation comes from these small-to-medium sized companies, as we have greater flexibility than the bigger ones. However, the new in vitro diagnostics regulations are a greater challenge for us than for the bigger businesses, and so innovation will become harder to obtain.