NEW YORK (GenomeWeb) – Thermo Fisher Scientific today said that it has completed the listing of the Ion PGM Dx next-generation sequencing system with the US Food and Drug Administration as a Class II medical device.
As Clinical Sequencing News reported in June, Thermo Fisher planned to register the Ion Torrent PGM with the FDA rather than go through the 510(k) process, as the instrument had the same intended use as Illumina's FDA-cleared MiSeqDx platform. It also said at the time that it would market the instrument as Ion PGM Dx.
FDA categorizes medical devices into three classes, with Class I considered to be low risk and subject to the least regulatory controls and Class III deemed the highest risk devices and subject to the highest level of regulatory control, often requiring agency approval before they can be marketed.
The Ion PGM Dx platform was designed to meet the needs of the clinical laboratory and is intended for targeted sequencing of human genomic DNA using peripheral blood samples, Thermo Fisher said. It added that the system "supports reliable development and implementation of user-defined NGS diagnostic assays in a clinical laboratory and enables 21 CFR Part 11 compliance" — a code of regulations that define the criteria under which electronic signatures are considered trustworthy and equivalent to paper records.
The Ion PGM Dx system will include the instrument-specific library kit, template kit, sequencing kit, and 318 chip. The library kit is based on 200bp chemistry and will include barcodes to enable the cost-effective and flexible processing of up to 16 samples on a single run. The system provides integrated data analysis software for sample and reagent tracking capability, QC metrics, audit trails, and software controls so that clinical labs can maintain high-performance standards with the implementation of each new assay, Thermo Fisher said.
"As we look to the future, we plan to continue investing in our Ion PGM Dx System by enhancing user-defined NGS diagnostic assay capabilities and by providing an expanded menu of clinically focused IVD diagnostic NGS assays for our customers, with an emphasis on oncology," Thermo Fisher President of Life Science Solutions Mark Stevenson said in a statement.