The University of Gdańsk Technology Transfer Centre has just sold the rights to an invention by prof. dr hab. Adam Lesner and dr Natalia Gruba from the Faculty of Chemistry UG. Scientists have developed a diagnostic test for detecting epithelial cancer of the urinary tract, commonly known as urinary tract cancer. It will improve patients' quality of life and increase the efficiency of diagnosis of this disease.

The work on the test was complex and took several years. All sold inventions of prof. Adam Lesner and dr Natalia Gruba - i.e. four Polish patents and one European patent - include a diagnostic test for detecting cancer of the urinary tract epithelium in their scope.

The method for diagnosing this type of cancer, invented by chemists from the UG, is a huge success and an alternative to the methods currently used in practice: a bioanalytical method for identifying cancer cells in a urine sample, imaging using ultrasound (USG) and speculum methods. In addition, it is completely non-invasive for the patient - only a urine sample is taken to detect the disease, even at a very early stage.

The UG Technology Transfer Centre, which has been involved in cooperation with the test's developers almost from the beginning, has just sold the rights to the test to Urteste, which will carry out further research and development (R&D) and ultimately market the product. 

‘The process of technology transfer of innovative research results from the university to the market is very complex. The UG CTT team, in cooperation with scientists, constantly monitors innovative research results and submits for patent protection those that have a real chance of later entering the market. We are pleased that we manage to conclude the commercialisation processes and sell the rights to inventions created at the UG,' says CTT Director Katarzyna Gronowska. ‘The partnership with Urteste is just beginning, but we look forward to further fruitful cooperation on developing other technologies originating from UG. Urteste is a reliable partner specialising in innovative technology to detect cancer at early stages of development; in a short period, it went public and became a joint stock company from a limited liability company.’

As the CEO of Urteste points out, further development of the bladder cancer detection test is an important undertaking for the company.

‘The first step is to conduct intensive research and development (R&D) works to develop an effective diagnostic test. A vital aspect of the project's development will, of course, be its financing. The company will invest significant resources in R&D and use its own laboratory infrastructure. Still, we will also seek external sources of funding, mainly in the form of grants,’ says Urteste CEO Grzegorz Stefanski. ‘In the context of the commercialisation of the project, we plan to look for a business partner to help us commercialise the test. This partner could be a diagnostic company with experience in marketing similar products,’ he adds.

Creating a non-invasive test to diagnose urinary tract cancer is an outstanding achievement for the UG research team. How did the idea for the research come about, and what was the road to commercialisation like? We ask the author, prof. Adam Lesner from the Laboratory of Biochemical Analytics and Nanodiagnostics at the Department of Environmental Technology, Faculty of Chemistry UG.

Elżbieta Michalak-Witkowska: - Do you remember the beginnings of the work on the test?

Prof. dr hab. Adam Lesner: - My research group, operating within the Laboratory of Analytical and Biochemical Nanodiagnostics, has been working on proteolytic enzymes, i.e. enzymes that digest proteins and peptides, for a very long time. Initially, we worked on a system with one known enzyme and tried to look for its activity. This went on for 25 years - we would pick one enzyme, analyse it, and create specific chemical tools, which were the basis of our patent. At some point, we decided to look for a particular type of enzyme - not just available off the shelf 'commercially'. We were looking for the activity of specific enzymes in body fluids: blood, plasma, urine and saliva. Our idea was to check if we could see the activity of particular enzymes in a more complex biological system where enzyme activities overlap. Initially, we focused on plasma, which yielded strongly unsatisfactory results. The second stage of the study was saliva and urine. We noticed that urine was very well suited to our research. When we found that the enzyme activity was low in urine and reflected the state of the body well, we decided that this area was worth exploring further and that the research should continue.

- That was seven years ago, in 2017?

- Yes, we had already come to a solution by then, but unfortunately, we were not able to get funding for further research, and we had to invest a significant amount of money. Instead, we had a compound that, when exposed to the urine of people with urinary cancer, broke down (whereas it did not break down in the case of healthy people). This activity we were able to monitor, study and record.

- Listening to your story, I can see that the whole implementation-commercialisation adventure was very intricate in this case.

- You could definitely put it that way. Intricate, multi-stage and bumpy. From the beginning, however, we were confident we were heading in the right direction. We developed a prototype quite quickly. Still, our solution needed to be improved, and its diagnostic parameters had to be defined. When, in the course of research carried out in cooperation with the Department of Urology at the Vincent à Paulo Hospital in Gdynia, headed by dr Lech Stachurski, it turned out that the efficiency of our test was better than good - it showed an efficiency of 80-90 per cent - we knew we could not give up.

- From the point of view of a scientist, how do you view cooperation with the socio-economic environment?

- When you are not a businessman by nature, the business environment and all the intricate procedures of working with it can overwhelm you. This is where the role of the UG Technology Transfer Office is essential; the Office supports scientists at every stage - from filing a patent application and securing ownership rights to finding a business partner. Their assistance with monitoring fee deadlines at the Patent Offices, responding to numerous letters or performing a range of additional market analyses, valuations, and studies is extremely valuable.  Of course, I have colleagues who successfully combine the roles of scientist and businessman, but this requires a lot of energy and knowledge of the market.

- Can a young scientist with an idea for an invention implement it, and if so, how? Are the procedures we have at the university helpful and clear in this regard?

- The procedures are formally easy; they are also nicely written out and enriched with diagrams. But some terms or concepts a scientist simply does not understand. Nor do we know the potential market we could contact to make a proposal to companies more interested in our solutions.

For a young scientist to go from ground zero, i.e. from an idea, to reaching what I call a critical mass, and then to present the concept to a non-scientific audience, to get funding, to convince investors who can fund a certain stage of research for a promise that is realistic at that moment - is a very big and difficult challenge.

I can imagine a scientist with a brilliant idea without the funds to market his solution.

- So it's all about money - and not small amounts.

- Let me use an example. My area of interest is disease diagnosis. In order to introduce an invention to the market, it is necessary, among other things, to perform a so-called medical experiment. This gives objective results, thanks to which we already know that our invention is sufficiently effective. The cost of such an experiment in our country is up to one million zlotys. With an uncertain result (because, despite the belief in their invention, a scientist, especially at the beginning of the road to commercialisation, cannot speak of any certainty), it isn't easy to find these funds. Young scientists may have a problem with this, so even a breakthrough invention may not meet with financial support. It is also worth remembering that a given idea is never the last. A scientist always thinks that their invention should get funded.

- You are starting a partnership with Urteste. Is it a real chance for your test to appear on the market soon?

- Work on the test needs to continue. We need to validate our results in an independent centre, conduct the aforementioned medical experiment and prove that the test is effective enough to register it as a medical device. Again, this is a long and bumpy road. 

- What will the test be used for? Are you most interested in showing the progression of a disease in a particular environment, analysing risk groups or perhaps using it on the general population?

- Each of these purposes requires the construction of a different test. The answer to this question, the selection of the target group, is still unknown. The decision must be made by the Company.

- What is there to wish for scientist-inventors?

- Certainly more money for R&D projects. There is not a lot of it right now.  Well, and a project pool for hazardous ideas, i.e. ideas that have no chance of being understood among experts.

- I keep my fingers crossed for that and wish you good luck. Thank you for the interview.