CLN Article

CE Mark Granted to Test That Predicts Colorectal Cancer Treatment Response

Regulatory Roundup: November 2017

IntegraGen has received the CE mark for its miRpredX 31-3p test, which is intended to guide treatment for patients with RAS wild-type metastatic colorectal cancer. The test quantifies the expression of the microRNA miR-31-3p in formalin-fixed, paraffin-embedded tumor samples using quantitative reverse transcription polymerase chain reaction. A recent study in the Journal of Clinical Oncology demonstrated that expression of miR-31-3p is a predictive marker of response to treatment with anti-epidermal growth factor receptor (EGFR) therapy such as cetuximab. The study also demonstrated that patients with miR-31-3p expression levels below a predefined threshold respond better to chemotherapy plus cetuximab than to chemotherapy paired with bevacizumab, an anti-vascular endothelial growth factor receptor (VEGF) therapy. Leveraging the predictive power of miR-31-3p, the miRpredX31-3p test is designed to help healthcare providers choose between first-line anti-EGFR therapy or anti-VEGF therapy for RAS wild-type patients. The test also forecasts when second or further lines of treatment with anti-EGFR therapy would be beneficial versus chemotherapy alone. 

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