From Vision to Reality

Growing tumoroids that optimally replicate the patient tumour is not trivial. 2cureX has 15 years’ accumulated experience optimising this process. We therefore deliver consistent, repeatable, and accurate results that make our IndiTreat® test suitable for clinical use.

A critical part of our process is interpreting the impact the drugs have on the tumoral cells. Our Artificial Intelligence-powered image analysis allows us to measure even the smallest changes within the required timeframe.

Our Management Team consists of experts with long and successful careers in their field, particularly in developing and rolling out in Vitro Diagnostics products in the market.

Conducting all internal processes according to ISO 13485 is not only a must for getting the IVD CE-marking on our IndiTreat® products, but a way to ensure their quality, safety and regulatory compliance. IndiTreat® is one of the very few patient derived-tumoroid tests that is CE-marked as an IVD.

We have built solid IP protection around the most critical elements of the IndiTreat® process, ensuring our freedom-to-operate and making it an important value driver of our company.

Reaching out to all stakeholders, including healthcare professionals, patients, economic decision-makers and policy makers is crucial when introducing a new concept in the medical field. At the end of 2022, IndiTreat® is actively promoted in 20 countries in Europe and Middle East through a hybrid network of distributors and direct operations.

We have built privileged relationships with Key Opinion Leaders and hospitals across Europe over the last 15 years. These relationships have been and continue to be crucial in developing products that address true medical needs and bringing them into clinical routine.

The IVD industry does not sit still and nor do we. We are constantly researching ways to further improve the preparation of tumoroids, to extend our portfolio of tests, and to optimise our processes in order to keep our leading position in the space.

Turning leading-edge technologies into products in one of the most tightly regulated industries in the world requires us to follow particularly strict processes and protocols. Our products are developed according to the ISO 13485 standard to ensure quality, patient safety and regulatory compliance.

Beyond developing the IndiTreat® products, we offer clinical testing services in our own facilities in Copenhagen. Here we receive patient samples from our customer hospitals and return the results in the form of a patient report that oncologists use to decide on the best therapy for that specific patient.

Clinical Studies are an ongoing requirement. They provide data and build evidence for regulatory approval of new products, but Studies are also needed to achieve reimbursement or to change clinical practice through the inclusion of the product in guidelines.

IVD is the most tightly regulated industry in the world. A deep understanding of the regulatory landscape and the definition of the right regulatory strategy can make the difference between making it to the clinical routine market or not. Our team has vast experience introducing new products into this complex environment.

Reimbursement of IVDs in Europe is extremely fragmented and complex whereby each country, and sometimes even each Region within a country has a different system. Payers can include public or private insurance schemes, hospitals or individuals, and the process of setting up coverage and pricing terms and conditions with each of them is a critical activity.

We are in continuous interaction with hundreds of oncologists across Europe and the Middle East, directly and through our distributors. We are constantly expanding our reach, scouting the different countries in search of a suitable distributor, signing them up, training them and then supporting and monitoring their local operations. Interacting with customers through multiple channels ensures their awareness and support of IndiTreat® products.

Our customers include healthcare professionals (mainly oncologists and pathologists) but also economic decision-makers at hospitals and other stakeholders such as policymakers, insurance companies and patients.

While our customers are healthcare professionals – oncologists and pathologists – our vision more accurately addresses their patients. We are introducing a paradigm shift in the way that these cancer patients are treated. We help to ensure that they are prescribed the drugs that have the greatest chance of success. Why should they take drugs that are toxic and have side effects? Why should they waste their valuable, limited time with treatments that may not work while others are more likely to have an efficacious effect?

Our vision is that functional drug sensitivity testing becomes routine – alongside other diagnostic approaches such as genomics and proteomics - for every cancer patient before any treatment decisions are made, so that personalised medicine finally becomes truly personal.

Our vision and ambition extend beyond the sphere of personalised medicine, however. It is our strong conviction that the way in which drugs are used around the globe needs to change. This is reflected also in the concerns expressed by the WHO and almost every other healthcare-related organisation.

A paradigmatic example is the indiscriminate use of antibiotics in the past, which gave way to resistances and the appearance of “superbugs” (strains of bacteria, viruses, parasites and fungi that are resistant to most of the antibiotics and other medications commonly used). Billions are wasted on non-helpful therapies. Why use chemotherapy that is not going to work? Why waste already scare resources? Functional drug sensitivity testing can help.

We are on the verge of a paradigm shift in the way cancer is treated. The increasing number of papers and studies demonstrate without doubt that awareness for functional drug sensitivity testing is growing. A recent study we performed amongst 140 oncologists in three of our prime distribution countries proves this further. The global market size is estimated at around 1 billion Euros for colorectal cancer applications only.

With the processes, people and expertise described in this Market Approach, we believe we have the necessary pieces in place to take the leading role in this shift, and so to change the way therapy decisions are made for the benefit of patients, healthcare professionals and the healthcare system as a whole.