EntroGen Receives CE-IVD Mark for BRCA Complete Test

May 18, 2017

NEW YORK (GenomeWeb) – EntroGen said today that it has received CE-IVD marking for its BRCA Complete kit for exome sequencing of the BRCA1 and BRCA2 genes.

The test is a targeted next-generation sequencing assay for use on Illumina's MiniSeq, MiSeq, and NextSeq platforms. It can detect somatic mutations in BRCA1 and BRCA2 with limit of detection of roughly 2 percent and uniformity and average sequencing coverage of 95 percent and 0.2X, respectively, the company said.

The kit also comes with data interpretation software for reporting clinically relevant mutations.

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