2cureX announces CE-IVD marking of its IndiTreat test
October 9, 2018
Press Releases Regulatory
2cureX AB (“2cureX”), a leading company in conducting individual treatment design of cancer patients, is pleased to announce the receival of CE-IVD Marking of its product IndiTreat®, which is constructed to tailor individual treatments for colorectal cancer patients. The CE-IVD marking entitles 2cureX the right to sell IndiTreat® tests in Europe.
Ole Thastrup, Chief Executive Officer of 2cureX, commented, “The CE-IVD marking of IndiTreat® is a major milestone for 2cureX. Our strong patent portfolio, the CE-IVD marking and our (positive) ongoing multinational clinical trials put 2cureX in a unique position to successfully launch IndiTreat® into the European market as planned in 2020. The thorough and comprehensive CE-IVD documentation and implemented processes open for fast registration of additional products beyond colorectal cancer”.
The IndiTreat® technology generates thousands of small micro-tumors (tumoroids) from a small tissue sample obtained from the patient’s primary tumor or metastasis. IndiTreat® allows testing of all approved cancer treatments to determine to which the patient is sensitive and to which the patient is resistant. IndiTreat is currently being clinically validated in both colorectal cancer and ovarian cancer.
“Achieving CE-IVD for IndiTreat® is a major milestone for 2cureX after years of test development and clinical validation”, says Maarten van der Linden, Chief Business Officer of 2cureX “The CE-IVD mark is a trade passport for the highly attractive European marketplace for IVD’s: it will allow our organization to prepare for launch excellence on the European market where 260.000 colorectal cancer patients annually receive medical treatment and therefore are eligible for Individualized Treatment.”
IndiTreat® will be marketed as a CE-IVD product under the Directive 98/79/EC for in vitro diagnostic medical devices. CE-IVD marking of IndiTreat® follows the successful technical validation of the test, it’s attributes and the completion of a comprehensive clinical evaluation documenting the clinical applicability of the technology.
Sedermera Fondkommission is the Certified Adviser of 2cureX.
For more information about 2cureX:
|Ole Thastrup, Chief Executive Officer||Maarten van der Linden, Chief Business Officer|
|E-mail: firstname.lastname@example.org||e-mail: email@example.com|
|Phone: +45 221153 99||Phone: +45 22902469|
This information is information that 2cureX AB is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person set out above, on October 9th, 2018.
2cureX has developed a test called IndiTreat® (Individual Treatment Design), which is a patented and CE-IVD marked test for selecting the right drug for the right patient. IndiTreat® establishes thousands of 3D micro-tumors that are functionally similar to the patient’s tumor. From a large panel of approved cancer treatments IndiTreat® selects the best treatment for the individual patient. IndiTreat® is expected to become a standard tool in the treatment design for cancer patients.
IndiTreat® is currently being clinically validated in colorectal and ovarian cancer.
The company is listed at the Nasdaq First North stock exchange in Stockholm (symbol “2CUREX”).