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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

US Booster Eligibility Decision

The US CDC director recommends that people at high risk of developing COVID-19 due to their jobs also be eligible for COVID-19 boosters, in addition to those 65 years old and older or with underlying medical conditions.

Arizona Bill Before Judge

The Arizona Daily Star reports that a judge weighing whether a new Arizona law restricting abortion due to genetic conditions is a ban or a restriction.

Additional Genes

Wales is rolling out new genetic testing service for cancer patients, according to BBC News.

Science Papers Examine State of Human Genomic Research, Single-Cell Protein Quantification

In Science this week: a number of editorials and policy reports discuss advances in human genomic research, and more.