NanoString Technologies said today that it has received International Organization for Standardization 13485:2003 certification for the nCounter Analysis System, NanoString’s multiplexed molecular detection instrument and reagents.
The ISO 13485:2003 certification, an internationally recognized quality standard for medical devices, covers the design, development, production, sales, and service of the nCounter system, NanoString said. The certificate demonstrates that NanoString has successfully implemented a quality management system that conforms to the worldwide standard for medical device and diagnostic manufacturing, the company added.
The nCounter system comprises a sample prep station and digital analyzer that reads NanoString's gene expression CodeSets, color-coded cartridges containing immobilized nucleic acid probes for various gene expression assays.
According to NanoString, the technology can detect and count hundreds of gene transcripts simultaneously with a sensitivity of less than one copy per cell. The company has been positioning its nCounter gene expression assays as bridging a gap between qPCR and microarrays.
"Our international customer base can be assured that the products we deliver today are of the highest standards, and that the ISO 13485:2003 criteria will provide a quality foundation upon which we and our partners will develop new diagnostic products," Mary Tedd Allen, vice president of manufacturing for NanoString, said in a statement.
The ISO is the world's largest developer and publisher of international standards. NanoString’s ISO 13485:2003 certificate was awarded by G-MED North America, a subsidiary of Laboratoire National de Métrologie et d'Essais.
Osmetech said last week that the US Food and Drug Administration has cleared the company's eSensor thrombophilia risk test, a multiplexed molecular diagnostic test for four genetic markers associated with thrombosis.
The test panel includes Factor V Leiden, Factor II Prothrombin, MTHFR 677, and MTHFR 1298, and is designed for use on the company's XT-8 system, a DNA detection platform for hospital and reference laboratories. The thrombophilia risk test can be configured to report out single genetic mutation results or various combinations including a FactorV/Factor II-only result, or the full panel of mutations, Osmetech said.
PerkinElmer this week introduced for use in the European Union its prenatal BACs-on-Beads, or BoBs, in vitro diagnostic assay for rapid prenatal testing of multiple genetic diseases.
The prenatal BoBs assay is the first IVD product from the company's multiplexed bead-based technology product family. BoBs analysis comprises hybridization of DNA sample sequences to BAC-derived probes representing identified target regions. Samples are enzymatically labeled with biotin, and after hybridization in a 96-well plate, a fluorescent streptavidin-phycoerythrin reporter is bound to the biotin labels.
Male and female reference DNA is also hybridized, and the fluorescence ratio between each sample and references indicates whether there is a gain or loss in the sample at the location of each BAC probe. Sample labeling is done enzymatically, which provides significant amplification of minute DNA amounts, according to PerkinElmer.
The assay enables targeted detection of DNA gains and losses in prenatally relevant regions, including the detection of aneuploidies of chromosomes 13, 18, 21, X, and Y; and DNA copy number changes in nine microdeletion syndrome regions. These chromosomal abnormalities are linked to DiGeorge syndrome, Williams-Beuren syndrome, Prader-Willi syndrome, Angelman syndrome, Smith-Magenis syndrome, Wolf-Hirschcorn syndrome, cri du chat, Langer-Giedion syndrome, and Miller-Dieker syndrome.