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New Products: Illumina's MiSeqDx Universal Kit; AC-Gen Reading Life's HC-Gen Test

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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.

The Scan

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A randomized pilot study in the Journal of Medical Genetics points to similar outcomes for breast cancer patients receiving germline BRCA testing through fully digital or partially digital testing pathways.

Survey Sees Genetic Literacy on the Rise, Though Further Education Needed

Survey participants appear to have higher genetic familiarity, knowledge, and skills compared to 2013, though 'room for improvement' remains, an AJHG paper finds.

Study Reveals Molecular, Clinical Features in Colorectal Cancer Cases Involving Multiple Primary Tumors

Researchers compare mismatch repair, microsatellite instability, and tumor mutation burden patterns in synchronous multiple- or single primary colorectal cancers.

FarGen Phase One Sequences Exomes of Nearly 500 From Faroe Islands

The analysis in the European Journal of Human Genetics finds few rare variants and limited geographic structure among Faroese individuals.