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.
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.
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.
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.
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.
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.
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.
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.
Please contact 2cureX for more information