IntegragenIntegraGen, a company specializing in the transformation of data from biological samples into genomic information and diagnostic tools for oncology, announced on September 7, 2017 the CE-IVD marking and commercial launch of its miRpredX 31-3p test kit in the European Union.
This is the first positive theranostic test for patients with metastatic colorectal cancer.

The utilization of the miRpredX test can identify metastatic colorectal cancer patients who will likely achieve a better response to anti-EGFR drugs like cetuximab and its use will enable clinicians to better individualize treatment approaches” said Professor Michel Ducreux, Head of the Gastro-enterology Unit at the Gustave Roussy Cancer Center in Villejuif, France. “As such, the results of this test will enable oncologists to select the therapy likely to provide the greater clinical benefit for a given patient”.

miRpredX 31-3p test kitAchieving CE-IVD for the miRpredX 31-3p kit is a significant milestone for IntegraGen after over 5 years of test development and clinical validation”, stated Yann Gaston-Mathé, Director of Molecular Diagnostics at IntegraGen. “We anticipate strong interest for this test as a result of the demand by oncologists for better tools to personalize treatment approaches for cancer patients. We are extremely pleased to execute this critical step in our corporate strategy and to launch our commercial efforts for miR-31-3p in a worldwide market estimated at $150 million.”

The miRpredX kit will be marketed as a CE-IVD product under the Directive 98/79/EC for in vitro diagnostic medical devices. CE-IVD marking of the kit follows the successful technical validation of the test and completion of several studies documenting the clinical performance of the test.

For more information on the miRpredX 31-3p test visit www.miRpredX.com.