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HTG Achieves ISO 13485:2003 Certification

NEW YORK (GenomeWeb News) – HTG Molecular Diagnostics said today it has received ISO 13485:2003 certification for the design, manufacture, and distribution of instruments, software, reagents, and test kits for gene expression analysis.

The certification covers the design, development, production, and sale of the HTG's qNPA technology-based products and services. According to the company's website, the gene expression technology combines a lysis-only, no amplification protocol and multiplexing of up to 47 genes per well for the multi-parameter evaluation of any sample type.

In order to get certified, the Tucson, Ariz.-based firm had to demonstrate it has quality management systems to meet customer and regulatory requirements for the design and development of medical devices, it said.

The Scan

Genome Sequences Reveal Range Mutations in Induced Pluripotent Stem Cells

Researchers in Nature Genetics detect somatic mutation variation across iPSCs generated from blood or skin fibroblast cell sources, along with selection for BCOR gene mutations.

Researchers Reprogram Plant Roots With Synthetic Genetic Circuit Strategy

Root gene expression was altered with the help of genetic circuits built around a series of synthetic transcriptional regulators in the Nicotiana benthamiana plant in a Science paper.

Infectious Disease Tracking Study Compares Genome Sequencing Approaches

Researchers in BMC Genomics see advantages for capture-based Illumina sequencing and amplicon-based sequencing on the Nanopore instrument, depending on the situation or samples available.

LINE-1 Linked to Premature Aging Conditions

Researchers report in Science Translational Medicine that the accumulation of LINE-1 RNA contributes to premature aging conditions and that symptoms can be improved by targeting them.