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Thermo Fisher Scientific Obtains CE-IVD Mark for Targeted NGS Oncology Test, Analysis Software

NEW YORK – Thermo Fisher Scientific said on Tuesday that it has received CE-IVD marking for its Oncomine Dx Express Test, a next-generation sequencing tumor mutation profiling test, and the companion Oncomine Reporter Dx analysis software and has launched them.

Thermo Fisher said the test can detect deletions, insertions, substitutions, and copy number gain present in 42 genes, as well as fusions or splicing variants in 18 genes from the DNA and RNA in formalin-fixed, paraffin-embedded (FFPE) tumor tissue samples of solid malignant neoplasms.

This assay also detects deletions, insertions, and substitutions in 42 genes, and fusions or splicing variants in seven genes from cell-free total nucleic acid (cfTNA) extracted from plasma samples of non-small cell lung cancer (NSCLC).

In addition to the test, the company also released the companion Oncomine Reporter Dx software, which allows healthcare providers to easily assess the genomic test results. Along with the recently launched Ion Torrent Genexus Dx Integrated Sequencer, the assay and software can offer an automated end-to-end CE-IVD workflow, the company said.