2cureX CEO-Interview Ole Thastrup CE-IVD status IndiTreat® and 2cureX commercial outlook
Last week, 2cureX took a big step towards market launch of IndiTreat by obtaining CE-IVD labelling of the product. Below, CEO Ole Thastrup tells us more about what the CE certificate means and the way forward for 2cureX.
Initially, tell me more about what a CE marking is and what it means in practice?
The CE marking is a universal approval process that applies to different products, such as everyday appliances, in accordance with specific directives that impose specific requirements that correspond to specific standards. For medical devices and especially IVD products, it is very different. Medical devices are subject to strict regulations and it is important to remember that these rules aim to protect the consumers when the product is used. It is a huge effort to get the CE-IVD labelling. The documentation consists of over a thousand pages.
If we practically apply this to our business, the CE-IVD labelling simply means that our product IndiTreat now can be sold in all EEA countries (EU, Iceland, Norway and Lichtenstein). For 2cureX, the CE-IVD marking is thus a quality mark for the IndiTreat test, which has opened the door to an important market. The CE-IVD marking makes 2cureX a much stronger company with significantly lower market risk for our product IndiTreat. We have therefore cleared a major obstacle on the way to become a commercial MedTech company.
When does the market launch of IndiTreat take place? What remains before the market launch?
We are planning launch IndiTreat in Denmark, Sweden, Germany and the UK in 2020. In order to achieve this ambitious objective, it was very important for us to receive the CE-IVD marking of IndiTreat in 2018 as it is a prerequisite for preparing the market launch.
Achieving the CE-IVD marking is an essential step on our way to the market. Even though IndiTreat first will be marketed in 2020, the CE-registration will allow us, before originally planned, to full-heartedly prepare our launch markets for the introduction of IndiTreat. IndiTreat is a tool for oncologists in individualize cancer treatment, and our customers are hospitals, healthcare providers and patients. 2cureX is conducting clinical trials at major cancer hospitals in Denmark, Germany and the United Kingdom. Clinical data and recommendations from key oncologists at these hospitals are important components of the market preparation.
What is the size of the market?
At present, 260,000 colorectal cancer patients in Europe are treated annually with traditional cancer drugs, and all of these are therefore suitable for individual treatment using IndiTreat. In the case of ovarian cancer, a disease that often affects younger women with fatal consequences, the European Medicines Agency (EMA) notes that approximately 154,000 European women suffer from the disease. In other words, the potential market for IndiTreat, where the CE-IVD labelling now has opened possibilities, is significant already within the two initial indications.
In conclusion – what’s next for 2cureX?
The next step is to work with our strong clinical partners, other key opinion leaders and potential customers to prepare the markets in the Nordic countries, Germany and the UK before launching IndiTreat. Oncologists and patients need to get an understanding that IndiTreat is the puzzle piece that is missing today to implement the concept of individualized cancer treatment. We therefore have close dialogues with leading oncologists and actively participate in conferences within the area. On top of that we also cooperate with Europe’s largest colorectal cancer patient association, EuropaColon, which plays a very important role in bringing the message of individualized treatment to the most important players – the colorectal cancer patients.