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Biocartis Gets CE Mark for EGFR Mutation Test

NEW YORK (GenomeWeb) – Biocartis today said that it has CE marked its Idylla EGFR Mutation Test for lung cancer, which can now be sold throughout the European Economic Area.

The test enables detection of 51 EGFR mutations directly from one slice of FFPE tissue, which the firm said is in contrast with traditional EGFR testing methods that often require up to six or more tumor slices. The PCR-based test provides results in 2.5 hours and requires less than 2 minutes of hands-on time, according to Biocartis.

The firm further stated that in a study presented at the American Society of Clinical Oncology annual meeting in Chicago last week, the Idylla EGFR Mutation Test produced results faster and easier than a commonly used pyrosequencing-based method.

The Mechelen, Belgium-based molecular diagnostics firm now has five CE-marked Idylla tests for melanoma, colorectal, and lung cancer. The most recent of those was its Idylla NRAS-BRAF Mutation Test for colorectal cancer, which was CE marked last December.