Illumina has applied the CE mark to its MiSeqDx system and MiSeqDx Universal Kit, enabling laboratories enabling laboratories to develop in vitro diagnostic tests on the MiSeqDx. The system and kit now conform to the IVD Directive. The MiSeqDx Universal Kit includes the library preparation reagents, sample index primers, and sequencing consumables needed for laboratories to develop amplicon assays. The new functionality of the system and the new kit will begin shipping in Europe in November. Illumina received a CE mark for its two cystic fibrosis assays on the MiSeqDx system in July (CSN 7/3/2013).
AC-Gen Reading Life, a Spanish biotech company, has launched its HC-Gen test, a next-generation sequencing based hereditary cancer test. The assay analyzes 37 genes and 89 SNPs that confer a predisposition to breast, ovarian, colon, or pancreatic cancers.