Skip to main content
Premium Trial:

Request an Annual Quote

New Products: Illumina's MiSeqDx and FDA-Cleared Kits; Syapse's Syapse for Labs Software


Illumina has received premarket clearance on its MiSeqDx system, the MiSeqDx Cystic Fibrosis 139-Variant Assay, MiSeqDx Cystic Fibrosis Clinical Sequencing Assay, and the MiSeqDx Universal Kit.

The Cystic Fibrosis 139-Variant Assay screens for disease causing mutations in the cystic fibrosis transmembrane conductance regulator gene, including all of the ones recommended for carrier screening by the American College of Medical Genetics and Genomics and the American College of Obstetricians and Gynecologists. The Cystic Fibrosis Clinical Sequencing Assay assesses the entire protein coding region and the intron/exon boundaries of the CFTR gene. The Universal Kit provides the reagents necessary for laboratories to develop their own amplicon-based diagnostic assays on the MiSeqDx.

Syapse has launched Syapse for Labs, clinical reporting software that enables molecular profiling test reports to be generated and delivered to physicians via an interactive web portal. The software manages patient clinical information, omics data, and supporting laboratory data. Reports are generated using a configurable rules engine, which updates reports as evidence in the knowledge base evolves.

The Scan

Follow-Up Data Requests to Biobank Participants Ineffective, Study Finds

An effort to recontact biobank enrollees for additional information reports low participation in a new BMJ Open study.

Study Finds Widespread Transmission of Resistant Bacteria in Vietnam Hospitals

A sequencing study in The Lancet Microbe finds widespread transmission of drug-resistant Escherichia coli, Klebsiella pneumoniae, and Acinetobacter baumannii in two Vietnam ICUs.

Novel Brain Cell Organoids Show Promise for Autism Research

University of Utah researchers report in Nature Communications on their development of brain cell organoids to study SHANK3-related autism.

Study Finds Few FDA Post-Market Regulatory Actions Backed by Research, Public Assessments

A Yale University-led team examines in The BMJ safety signals from the US FDA Adverse Event Reporting System and whether they led to regulatory action.