INTERVIEW
Gabriele Salaris, Head of Marketing & Sales, Ulisse Biomed
Q: Hyris System™ is defined as a “diagnostic ecosystem”. Can you explain what this means and what components make it a modular and scalable ecosystem?
A: Absolutely. When we talk about an ecosystem, we mean a set of elements – physical tools, software, chemical reagents, digital services – that work together to provide a complete solution. In the case of Hyris System™, the ecosystem includes our bCUBE portable PCR analysis devices, cloud software applications such as bAPP for managing tests and data, a line of proprietary reagent kits, and complementary services such as development and OEM. All these components are designed to be modular, meaning they can be combined according to needs. For example, a customer can start with one instrument and a few kits, and then grow the system by adding other modules – additional devices in parallel, new diagnostic panels, integration with their own databases – all without changing platforms. This is what scalability is all about: being able to start small, perhaps a district laboratory with a single bCUBE, and grow to a network with dozens of devices and hundreds of tests per day, while maintaining the same software infrastructure. The basic idea is to offer an integrated platform where every piece talks to the others seamlessly. This means that users do not have to turn to five different suppliers for PCR machines, reagents, analysis software, cloud services, etc., but find everything in a single, coherent system that can be expanded over time. Alternatively, a central laboratory can dedicate a low-volume analysis line by taking advantage of the modularity and scalability of the Hyris System, without compromising existing laboratory workflows and protocols.
Q: Your target market ranges from clinical diagnostics to nutraceuticals to industrial OEM. How do you manage to address such diverse needs with a single platform?
A: That's right, the use cases are very diverse – from hospital laboratories looking for rapid reporting of infections, to nutraceutical companies wanting to certify the identity of a medicinal plant, to OEM partners who may integrate our technology into their own products. The beauty of the Hyris System is that it was designed from the outset with a multi-sector approach. The key is versatility: our platform performs nucleic acid analysis, and DNA/RNA is a universal language whether you are looking for a flu virus in a swab or checking the genetic code of Arabica coffee. So, the same bCUBE device can perform a clinical test, then a food test, then a veterinary test, simply by changing the reagent kit and protocol loaded onto bAPP. On the software side, we have designed bAPP and bDATA with configurable features: for example, you can activate specific modules for agri-food traceability, such as linking GPS coordinates to field tests, which is useful for those who carry out checks on raw materials. Or, for clinical customers, we have ensured compliance with health data privacy and security requirements. In short, the technological base is common, but through the software and services we are able to customise the experience for each sector. In addition, the business model is flexible: some customers purchase the instrument and kits, such as clinics, while others prefer an all-inclusive subscription service – for example, food companies that want X analyses per month without having to deal with technical details. In these cases, we offer tailor-made “platform-as-a-service” formulas. In short, a single platform, but customised in detail to meet different needs. It's like an operating system that can run different applications depending on the user.
Q: Let's talk about decentralisation in diagnostics. How does Hyris System facilitate this process and what are the benefits for laboratories and patients?
A: Decentralising diagnostics means bringing testing closer to where it is needed, reducing dependence on large centralised laboratories. Hyris System was practically created for this purpose. Our bCUBE devices are compact and portable, so you can place them outside the traditional laboratory: in a hospital ward, in a doctor's office, but also in a container at the border for veterinary checks, anywhere. They also run on batteries or a small inverter, so we have literally seen them operating in the middle of the African jungle as well as in a mobile clinic. This brings a huge advantage: reduced response times. In a clinical setting, performing a molecular test on site means getting a result in perhaps 60 minutes instead of waiting 24-48 hours for the results from the central laboratory, with the sample travelling and so on. Another advantage is that we lighten the load on large laboratories, reserving them for more complex tests, while routine or urgent tests can be handled locally. And then there is the issue of geographical accessibility: decentralisation means being able to offer advanced diagnostics even in remote areas or countries with limited resources, where certain laboratory services may not even exist. With our platform and cloud connectivity, the sample no longer has to move: the data moves. Finally, decentralisation improves the patient experience.
Q: The platform integrates cloud solutions and artificial intelligence algorithms. What specific functions do they perform and how do they make diagnostics smarter?
A: Artificial intelligence in our platform operates mainly on two levels. The first is the interpretation of results. In advanced molecular tests, such as multiplexes with many targets, the raw output is amplification curves and fluorescence numbers. We have developed algorithms that analyse these curves in real time and immediately provide an interpreted report – for example, “Sample POSITIVE for pathogen X, NEGATIVE for Y, internal control valid”. In practice, AI automatically performs the analysis that an experienced biologist would do by eye, recognising patterns in the curves and cross-referencing data from various channels. This reduces errors and, above all, helps when the operator does not have much experience, because the software guides them in the interpretation. The second level is more advanced: we are talking about data analytics at the test population level. With a cloud platform that collects a huge amount of test data (anonymised and aggregated, of course), we can apply machine learning algorithms to identify trends or anomalies. For example, AI could alert a laboratory that there has been an unusual spike in positivity for a certain strain of influenza in a certain area over the last week – an early sign of an outbreak. Or, in an industrial setting, it could correlate test results with production batches to help trace the source of contamination. In short, the cloud allows us to move from the level of individual tests to the level of diagnostic big data, and AI is the only way to extract value from this big data in real time. From the user's perspective, much of this work is “under the hood”: what they see is that the system learns and becomes more efficient as it is used. A concrete example: our interpretation algorithms are periodically re-trained with new data, so they continuously improve their accuracy and ability to handle edge cases. Ultimately, artificial intelligence makes our platform smarter, more proactive and more reliable, contributing to the ultimate goal of speeding up and automating diagnostics without compromising quality.
Q: In a scenario where competition includes large diagnostic companies, what is your Unique Selling Proposition? What makes Ulisse Biomed and Hyris System special in the eyes of an institutional investor?
A: I would say that our USP – Unique Selling Proposition – lies precisely in vertical integration and agility. Let me explain: many large companies compete on a single aspect, such as who has the fastest laboratory machine, the most extensive test menu or the best management software. Ulisse Biomed, having been created from the union of different skills (Hyris hardware, Ulisse chemistry), can offer a complete package that is difficult to replicate. Hardware + software + reagents + cloud, all in a single platform. For an investor, this means that we have built a barrier to entry: it is not easy for a new competitor to put all these pieces of the puzzle together. Furthermore, we are asset-light and flexible. Our bCUBE has already been developed and patented; our proprietary reagents are an important IP asset (nine patent families cover our technology platforms, such as Sagitta for molecular diagnostics). Investors also appreciate the fact that we are riding clear macro trends: the decentralisation of diagnostics, the demand for this type of test has an estimated market growing at a significant CAGR – and the interest in digital/AI solutions in medtech. In addition, Ulisse Biomed is an innovative SME listed on the EGM (European Growth Market) but with the ambition of a multinational: we invest heavily in R&D but at the same time we are signing commercial agreements all over the world, from the United States to South Africa. Agility and global vision. An institutional investor looks at the numbers but also at the history: in just over a year since the Hyris-UBM integration, we have launched new product lines (e.g., the sexually transmitted infection test line, which leverages distribution synergies with the newly launched HPV line) and entered into partnerships in emerging sectors such as medical cannabis and personalised medicine. All this confirms that our ecosystem is not a static concept, but a living platform that is expanding into various markets. In summary: our USP is to offer integrated and decentralised molecular diagnostics 4.0, where others offer individual pieces. We believe that this approach, combined with the execution capabilities we are demonstrating, makes us an attractive opportunity for those investing in the future of healthcare and biotech.
Q: What is Ulisse Biomed's vision for the next 5 years?
A: We will continue to innovate, for example by integrating new markers such as the microbiome for personalised nutrition, or by further developing pre-analytical automation. But always with the underlying idea of distributed genetic testing: integrating the analyses already carried out by central laboratories with those performed in laboratories distributed throughout the territory. In practice, becoming a de facto standard for decentralised diagnostics at a global level.
