Glycanostics is a Slovakian scale-up developing a highly accurate early-stage test for the detection of 11 types of cancer. Established in 2017 by two internationally renowned scientists, Jan Tkac and Tomas Bertok, the company is on a mission to provide cost-effective, non-invasive glycan diagnostics for the rapid detection of early-stage cancer, dramatically improving survival rates and eliminating ineffective therapies.
Glycanostics is also a member of the EIC Scaling Club New Biotech Platforms group. We had the pleasure of talking to Eva Kovacova, the CEO of this innovative company, to learn more about its journey so far and the road ahead.
Ensuring we understand the urgency and importance of companies like Glycanostics, Eva paints a picture of medical diagnostics, with a particular focus on cancer detection.
Diagnostics are inherently life-saving, yet current methods often fall short, representing a significant unmet medical need. Many existing diagnostic tools, including ultrasound, CT, MRI, and mammography, are not always accurate enough, easily accessible, or suitable for all patient groups. Their limitations frequently necessitate painful biopsies that ultimately yield negative results, exposing patients to unnecessary risks and potential side effects. And, while laboratory tests focus on proteins or genes, they, too, often lack sufficient accuracy.
While there’s a wide discussion of various genetic analysis options, a significant issue with genetic analysis is that it only reveals a higher probability of developing cancer, not the presence of the active disease itself. A genetic test may show that a patient's genetic library contains malignant information, but this information is not necessarily being expressed. Hence, a genetic flaw doesn't always mean the disease will manifest.
Glycanostics’ innovative approach focuses on glycomics, detecting glycans (complex carbohydrates), the products of active expression of malignant information (genes), and the activity of several proteins rather than just the genetic potential for the disease. The scale-up’s cancer diagnostic test uses patented technology that analyzes glycans in blood serum. Cancer cells release elevated levels of glycoproteins (cancer antigens) into the bloodstream, which serve as biomarkers for detection.
While the usefulness of glycans from a biological information perspective is known, until Glycanostics’ innovation, no fast and affordable method of their accurate detection and analysis was available.
“Our patented technology is a magnetic-based ELISA approach, making it compatible with the equipment used by laboratories worldwide, and no significant investment is required,” says Eva, and adds that the method will be compatible with high-throughput machines used by industry leaders to analyze large amounts of samples.
Glycanostics’ technology can detect 11 types of solid tumors – prostate, breast, pancreatic, lung, stomach, liver, thyroid, bladder, ovarian, colorectal, and testicular.
“We have to develop separate tests for each cancer type, but they’re all based on the same technology. And our mission is to create a world where cancer will be diagnosed early and treated successfully, because the early diagnosis means a much higher probability of successful treatment.”
Eva shares that Glycanostics’ prostate cancer test has shown excellent results with high accuracy during pre-clinical validations, which were done in the so-called gray zone. This zone includes patients with Prostate-Specific Antigen (PSA) levels between 3 and 10 ng/mL, where urologists often struggle to make a definitive diagnosis. Even within this difficult gray zone, the test demonstrated excellent performance.
Now, Glycanostics has progressed to the next stage, meaning the company is transferring its product into a format suitable for mass production and compliant with IVDR requirements. This transition is being executed in collaboration with their contract manufacturer in France, with a focus on creating a test that is highly user-friendly for clinical laboratories. Eva says the company is ready to start production of the first three pilot batches, conduct analytical validation, clinical validation, and finalize the regulatory dossier to obtain the CE mark and FDA approval.
Following the prostate cancer test, Glycanostics is making excellent progress on a breast cancer test, which will launch soon after. Preclinical validation for the breast cancer test is highly promising, with studies involving over 800 samples.
Asked to share the secret behind this remarkable success in medical innovation, Eva says that it’s the glycan analysis, which represents a new frontier in molecular biology.
“We are the first to develop a technology capable of analyzing glycans in a fast and affordable manner, a breakthrough that promises immense use for clinical practice.”
Crucial to this innovation are the people who pioneered it: the co-founders of Glycanostics, Jan Tkac and Tomas Bertok, who previously worked together at the Slovak Academy of Sciences. Jan, following several postdoctoral fellowships at prestigious institutions such as Oxford University and Lund University, returned to Slovakia to establish his own scientific research group. Working alongside his colleague Tomas, they jointly developed and patented the core glycan analysis technology in 2018.
Eva joined as CEO in 2021, instantly strengthening the core team with over 23 years of essential expertise in the pharmaceutical industry. Her background is defined by steering complex, multi-billion-dollar global M&A transactions and successfully leading large-scale organizational integrations and carve-outs (JV between GSK and Novartis, LifeScan carve-out from J&J) across EMEA and Latin America.
“There were two scientists struggling to attract investors. After bringing my extensive management experience and business knowledge, everything fell into place,” Eva comments on the core team of the company and adds that today, the scale-up has attracted about 20 experienced professionals locally and has a network of international advisors.
“It's a mix of great technology in a completely new area and people who are focused and dedicated to bringing this innovation to the benefit of patients.”
Even the most successful journeys face their set of challenges, and Glycanostics is no exception. Asked to share some examples, Eva says that Glycanostics’ hindrances can be divided into two areas: the typical challenges faced by diagnostic companies and fundraising.
“Biology can always surprise you and cause some delays,” Eva tells us, and adds that transferring the product into a format compliant with IVDR requirements necessitates passing numerous quality tests. This rigorous process is invaluable, as it consistently reveals areas that need refinement and improvement to ensure optimal market readiness.
Another typical challenge for diagnostic companies is the requirement for clinical validation studies, which are both costly and time-consuming. Moreover, as Eva explains, the already strict requirements for registering laboratory tests and medical devices in Europe have become even more stringent. “We accept no compromises when it comes to quality. Hence, we are fully compliant with all the requirements,” she adds on the company’s perception.
Glycanostics is working closely with external partners on several aspects: “For example, when it comes to preparing the regulatory dossier for CE mark or building our quality management system to be compliant with ISO 13485, we engage highly experienced experts.”
According to Eva, the second major challenge – fundraising – has become substantially more complex in the last few years. To overcome it, Glycanostics has turned to securing grants. “We received an ERC grant, EIC Accelerator. We have a Seal of Excellence for EIC Transition alongside several grants from the Slovak Recovery and Resiliency Plan. We’re supplementing the funding with grants, and we also work with the local crowdfunding platform,” Eva shares the creative approach to securing necessary funding.
Regarding crowdfunding, the recent pre-Series A round, which raised approximately €4 million, was funded by 400 investors, facilitated through a single crowdfunding platform.
“We are now looking for a Series A lead investor. As an EIC Accelerator beneficiary, we are eligible to receive investment from the EIC fund, and we need lead investors to facilitate this. We’re currently seeking €5 million from a lead investor, with a further €5 million to be secured from the EIC.”
As usual, moving towards the final part of our conversation with EIC Scaling Club member companies, we ask Eva about Glycanostics’ most important milestones. She smiles and says that there are quite a few, including receiving grants and success with the pre-clinical validations.
“We see really promising results that we have already discussed with several multinational diagnostic and pharmaceutical companies at various congresses. They are very interested in our product, specifically in licensing our tests once they are CE-marked and FDA-certified.”
Eva adds that some companies have also expressed interest in using Glycanostics’ cancer tests in clinical trials. This interest stems from observed results where successful patient treatment led to test values returning to levels seen in healthy populations, indicating the test's suitability for monitoring treatment efficacy and patient recovery during trials.
“We’ve heard others try to develop a similar technology, but none have been successful,” Eva tells us, and adds that Glycanostics has had great opportunities to introduce the company and the product at several international conferences and congresses. “We have twice been a part of the EU pavilion at the BIO International Convention Congress in Boston as one of the most promising European biotech companies.”
Additionally, being invited to join the EIC Scaling Club is a milestone that Glycanostics is celebrating:
“We get a lot of support and recognition through the EIC Scaling Club. We literally stand out from the crowd by being part of the Club.”
Eva finalizes our conversation by saying that she enjoys access to various mentors, as well as other companies, because scale-ups face similar challenges, and being able to discuss them is invaluable. She adds: “We meet at different events organized by the Club, where we can introduce ourselves to investors or congresses, such as BIO, which I mentioned, or events where we could introduce ourselves to hospital chains.”
The EIC Scaling Club is a curated community where 120+ European deep tech scale-ups with the potential to build world-class businesses and solve major global challenges come together with investors, corporate innovators and other industry stakeholders to spur growth.
The top 120+ European deep tech companies will be carefully selected from a pool of high-growth scale-ups that have benefitted from EIC financial schemes, other European and national innovation programmes, and beyond.
The EIC Scaling Club is an EIC-funded initiative run in partnership by Tech Tour, Bpifrance (EuroQuity), Hello Tomorrow, Tech.eu (Webrazzi), EurA and IESE Business School.
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