Thermo Fisher Scientific Gains CE-IVD Mark for Two Oncomine Tools

Thermo Fisher Scientific has received a CE-IVD mark for its Oncomine Dx express genomic test and Oncomine Reporter Dx software.

The Oncomine Dx test uses next-generation sequencing technology to deliver tumor mutation profiling in as little as 24 hours. The diagnostic test detects deletions, insertions, substitutions and copies present in 42 genes and fusions or splicing variants in 18 genes.

The Oncomine Reporter Dx software can quickly assess the genomic test results. The software matches the variant data to relevant information such as approved therapies, guidelines, clinical trials and peer-reviewed literature.

The company intends to combine the two tools with its CE-IVD marked Ion Torrent Genexus Dx sequencer for DNA or RNA extracted from tumor tissue samples or plasma samples.