The next-generation sequencing test and analysis software have been introduced to expand access to precision oncology biomarker testing. Credit: Thermo Fisher Scientific Inc.

Thermo Fisher Scientific has launched the CE-IVD (IVDD) Oncomine Dx Express Test and Oncomine Reporter Dx to expand access to precision oncology biomarker testing.

The Oncomine Dx Express Test identifies deletions, insertions, substitutions and copy number gain present in 42 genes, as well as fusions or splicing variants in 18 genes, from DNA and RNA in solid malignant neoplasms’ formalin-fixed paraffin-embedded (FFPE) tumour tissue samples.

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

The qualitative in vitro diagnostic (IVD) test provides clinically relevant tumour mutation profiling in 24 hours and according to professional guidelines, which supports healthcare providers in managing cancer patients’ therapy.

The Oncomine Reporter Dx software matches the variant data to relevant evidence, including approved clinical trials, guidelines, treatments and peer-reviewed literature, in a user-friendly and personalised report that ensures healthcare providers can quickly evaluate the genomic test results.

Thermo Fisher Scientific clinical next-generation sequencing (NGS) and oncology president Garret Hampton said: “Genomic profiling in precision oncology is transforming cancer care, but true clinical utility hinges on timely, actionable results.

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“By delivering an IVD NGS solution that provides rapid results with minimal training and hands-on time, we’re working to make these insights available in any lab or hospital to help connect patients to precision oncology treatments.”

The company stated that both the NGS test and analysis software will be available for use in clinical laboratories.

It also noted that the new assay and software, along with the recently introduced Ion Torrent Genexus Dx Integrated Sequencer, provide an automated end-to-end CE-IVD workflow.

This complete process can be operated from a single software interface and delivers results in a quick turnaround time of less than 20 minutes.

Thermo Fisher Scientific said that the CE-IVD workflow allows any laboratory to bring genomic testing in-house.