EntroGen Receives CE-IVD Mark for BRCA Complete Test

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.

EntroGen also sells its DNA Fragmentation Quantification and Library Quantification qPCR assays to help users assess sample and library quality control.

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