Thermo Fisher Scientific completed the listing of its Ion PGM Dx next-generation sequencing (NGS) system with the FDA for clinical use as a class II medical device.
Intended for targeted sequencing of human genomic DNA using peripheral whole-blood samples, the system supports the development and implementation of user-defined NGS diagnostic assays in a clinical laboratory and enables 21 CFR Part 11 compliance, according to Mark Stevenson, president of life science solutions at Thermo Fisher Scientific. The system was validated using a large control panel that contains an extensive number of germline variants that are representative of a range of human conditions, he continued, adding that when it is used for diagnostic assay development, customers may define, validate, lock, and publish protocols in a role-based workflow for implementation into routine use, from library construction to variant calling.
“Next-generation sequencing is rapidly becoming an indispensable tool for clinical laboratories around the world, allowing clinical professionals to simultaneously screen hundreds of genes from patient samples to provide key genetic information and enable patient enrollment within clinical trials,” said Stevenson. “The Ion Torrent platform and accompanying reagents provide a number of unique advantages to clinical customers, enabling accurate and reliable genetic variant analysis from more samples due to low DNA input requirements (10 ng) and faster turnaround times that reduce the time of sample to result.”