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IntegraGen Theranostic Test for Colorectal Cancer Gets CE-IVD Mark

NEW YORK (GenomeWeb) – IntegraGen today announced that its test kit for predicting patient response to anti-EGFR therapy has been CE-IVD marked, and the company will launch it in the European Union.

The test, miRpredX 31-3p, is a positive theranostic test for patients with metastatic colorectal cancer that quantifies the expression of miR-31-3p in formalin-fixed, paraffin-embedded tumor samples using standard quantitative reverse-transcription PCR, IntegraGen said. It added that miRpredX 31-3p predicts the potential clinical benefits associated with first-line anti-EGFR therapy compared to anti-VEGF therapy, or when second or additional lines of treatment with an anti-EGFR therapy is beneficial, compared to chemotherapy by itself, for patients with RAS wild-type mCRC.

A recent study demonstrated the utility of miR-31-3p expression as a predictive marker for overall survival and response to anti-EGFR therapy treatment, Évry, France-based IntegraGen said.

Achieving CE-IVD marking follows five years of development work and clinical validation of the test, IntegraGen Director of Molecular Diagnostics Yann Gaston-Mathé said in a statement. He added that the worldwide market for miR-31-3p testing is estimated to be $150 million.