Q&A – IndiTreat®

2cureX is happy to receive a number of questions and comments from our present and from potential future shareholders.

With the present Questions & Answers (Q&A) section, we would like to make these questions and their answers publicly available. Additional questions/comments should be mailed to info@2cureX.com.

Is IndiTreat® a drug/medical treatment?

Posted on 2019-01-22
No, IndiTreat is a laboratory test that can tell you which drug treatment that will work in the individual cancer patient and which treatment that will not work. In other words, IndiTreat is analyzing a large panel of drugs and combinations thereof, on the Individual patient’s tumor cells in vitro, before treatment is started. Immediately after the test has been performed the patient will be put on the most effective treatment.

At Sedermeradagen on 11. October 2018 you stressed the importance of the CE registration, can you explain what the CE-IVD labeling means with regard to introducing the IndiTreat® into the market.

Posted on 2018-10-12
The CE-IVD marking is a major milestone for 2cureX as it is required for the IndiTreat® market preparation and the subsequent market launch.
In detail there are 4 reasons why the CE-Certificate for IndiTreat® is such a critical milestone:
a. Med-Tech products in the field of IVD (In Vitro Diagnostics) need to adhere to the CE IVD Directive 98/79/EC, it grants IndiTreat® a CE-IVD certificate that serves as a trade passport for the European marketplace and will allow 2cureX to freely circulate its product throughout the 30 countries of the European Economic Area (EEA).
b. The CE-IVD label serves for med-tech products as a quality stamp, as it means that the organization has processes in place that ensure customers that the product delivers on its product-claims within the Intention for use.
c. The CE-IVD is a pre-requisite for market-access and reimbursement within the EU as well as certain major markets outside the EEA.
d. The CE-IVD certificate for IndiTreat® provides efficiency for launching products in other Tumor entities as there is now only one set of requirements and procedures to comply in terms of designing and manufacturing a product for the entire EEA.

When a product has the CE-IVD label, what does that mean in contrast to not having this label?

Posted on 2018-10-12
An IVD product that is placed on the European market must comply with the CE-IVD directive and carry the CE mark, in case the product lacks the CE-IVD label it will need to be registered as an RUO (Research Only) device and by definition is intended for research use only, and can’t be used for clinical use by physicians. This will impede market barriers in terms of market access and product reimbursement.

I am a shareholder in 2cureX, and I am excited about the prospect of the IndiTreat® test in future cancer treatment. You are now in colorectal cancer, can the test be applied to other cancers?

Posted on 2018-07-08
IndiTreat® is being clinical validated in two solid cancers: colorectal and ovarian cancer. It is important to 2cureX that clinical trials are conducted within the different cancer entities where we are launching the product initially. However, we have shown that the technology is applicable to other solid cancers.

How much effort is required by the lab in order to run the IndiTreat® test? As I understand the test, it kind of runs by itself when the medicine is applied, but the initial setup could take some time. I’m wondering how many tests a day one person can do and what the capacity would be staff wise. Do you require a lot of staff or can one person do many tests alone?

Posted on 2018-05-04
The IndiTreat® technology is easy to scale, and one person can run a large number of tests in parallel. Setting up the test facility is relatively easy done – it requires access to the 2cureX know-how and patent rights; but is not demanding staff wise. With regard to the setup of test-sites, we have strategically decided that we want to have a presence in all countries where we operate. This will have a very positive effect on the general uptake of the test in the individual countries.

58% is much better than 30%. But what makes you unable to reach higher? What is the obstacle in the method?

Posted on 2018-03-20
As mentioned above it is not the accuracy of the IndiTreat® test that is 58%, it is its ability, in the tested patient population, to identify an effective treatment. The reasons for it not being higher is that some patients will show resistance or low sensitivity towards all the treatments tested. It is likely that the percentage will go up when we include other types of cancer drugs in the test panel.

In 2cureX’s latest presentation you say that IndiTreat® will find a highly effective treatment for 58% of the patients compared to today’s approximately 30%. Is it true for colon cancer?

Posted on 2018-03-18
This is true for colon cancer on average for the different stages of the disease. For late-stage (IV), where the disease has spread to distant organs, most often the liver, the response is significantly lower.

Contact us

Please contact 2cureX for more information

Email: info@2cureX.com
Phone: +45 22115399
Web: www.IndiTreat.com

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Key benefits of IndiTreat

  • Tumor resistance
    Predict tumor resistance and sensitivity to cancer drugs
  • Right cancer treatment
    Select the most appropriate treatment, in accordance with guidelines or off-label
  • Better patient outcome
    Improve patient quality of life through in vitro testing of drug efficacy on the individual patient
  • Help chemo-naïve CRC patients
    Identify the most effective treatment in chemo-naïve colorectal cancer patients
  • Help late-stage CRC patients
    Identify the most effective treatment in late-stage colorectal cancer patients
  • Functional precision medicine
    Complement the genomic characterisation of tumours with functional data on resistance and sensitivity to drugs