IntegraGen's miRpredX 31-3p test was awarded a CE mark for use in the European Union.
Here's what you should know:
1. The miRpredX 31-3p is the first positive theranostic test for patients with metastatic colorectal cancer.
2. The test will be marketed as a CE-IVD product. The CE mark denotes the product is effective and safe.
3. The test identifies patients who would better respond to anti-EGFR drugs like cetuximab. It also allows physicians to take personalized medicine approaches.
4. IntegraGEn's Director of Molecular Diagnostics Yann Gaston-Mathe said in a release, "Achieving CE-IVD for the miRpredX 31-3p kit is a significant milestone for IntegraGen after only five years of test development and clinical validation. 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."