CARLSBAD, Calif.--(BUSINESS WIRE)--Thermo Fisher Scientific today announced that it has completed the listing of its Ion PGM Dx next generation sequencing system with the U.S. Food and Drug Administration (FDA) for clinical use as a class II medical device.
“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 Mark Stevenson, President of Life Science Solutions at Thermo Fisher Scientific. “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 (10ng) and faster turnaround times that reduce the time of sample to result.”
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