is near to complete without conversion from one R&D focused company, to one fully fledged in in vitro diagnostics company. Så very is evident av their recently released annual report as who describes the intensivework as the company closed down under the latest the year, inklusive the launch av without allra first product - IndiTreat mCRC 3L - one functional precision medicine tool - for oncologists. BioStock have taken a closer look.
As described in 2cureX annual report for 2020 Last year was marked by the launch of the company’s first product – IndiTreat mCRC 3L – in Europe. It marked a new phase for the Copenhagen-based in vitro diagnostics (IVD) company, which was able to take some important transformative steps from a primarily R&D focus to becoming a more commercially focused organization. Read more about the first rollout of IndiTreat here.
This transformation has continued in 2021. After presenting a commercial roadmap outlining its commercialization strategy in 2023, 2cureX made some changes to its management team, including the recruitment of I fernado Andreu as CEO of the company. Not long after, he was recruited Kenneth Johansen as new CFO. The two new appointments add expertise to develop new business opportunities in the international arena.
In March, 2cureX announced the completion of the TICC study in metastatic colorectal cancer patients. The press release also stated that the primary endpoint of the clinical trial had been met: IndiTreat-guided treatment in metastatic colorectal cancer improves progression-free survival (PFS) after eight weeks of treatment. Detailed results of the study will be published at ASCOconference in June.
To create en ny product category
Since then, the company, supported by last year’s capital raising of SEK 40 million through a directed new share issue, has been able to accelerate its business development activities, which aim to create a new product category in the market – Functional Precision Oncology – and to establish itself as a leading player in this market. Fernando Andreu speculates in the annual report that the upcoming changes in the IVD regulatory framework in Europe will transform the competitive landscape to 2cureX’s advantage. The company is currently working on updating its technical files to comply with the new regulations when they come into force – something that other companies and institutions offering functional tests may not be able to do, according to Andreu.
The CEO further reinforced his positive opinion in the report:
»The transition from a research technology to a clinical technology is not an easy one in a highly regulated environment like in vitro diagnostics, but the company is well prepared and is driven by a stable, experienced and highly motivated team. We are confident that we will be able to capitalize on and extend our lead as functional precision oncology continues to mature, thereby realizing both the vision that 2cureX was founded on and the expectations of our shareholders, to whom we are committed and who, to our great gratitude, have stood by us for another year.«
Bif one leader inname presectionsooncology
For the remainder of 2021, 2cureX will focus on finding the first users for IndiTreat – mCRC 3L in the key European markets. This already goes beyond 2cureX’s original plan to initially offer its product only in Sweden, Denmark, Finland and Norway due to the positive response to IndiTreat’s initial launch. Now, after careful assessment of market opportunities and entry barriers, 2cureX has added Italy, Spain, France and Poland to its priority countries, as this is where the company is already actively discussing with potential distributors and early users of IndiTreat.
Overall, according to 2cureX, IndiTreat has not only helped the company itself through the transformation from its previous focus on FoUtill to a commercial one; it has also helped functional precision oncology undergo a similar maturation process from being a strict research technique, to being a clinical tool and potentially becoming part of clinical guidelines in the near future – thereby driving the next wave in individual-based oncology.
The content of BioStock's news and analysis is independent, but BioStock's operations are to some extent financed by companies in the industry. This post refers to a company from which BioStock has received funding.
