In the era of personalized medicine, molecular profiling has become essential for the treatment of cancer patients. With an increasing number of genomic alterations becoming clinically relevant, sequential testing of individual mutations becomes a significant challenge for clinical laboratories. Next-generation sequencing (NGS), which can detect multiple alterations at once from a small amount of tissue, offers a solution.
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The Oncomine Dx Target Test is currently available in the following commercial labs:
|Reference lab||Telephone number||Website|
|Quest Laboratories, Inc.||866-697-8378||questdiagnostics.com|
|NeoGenomics Laboratories, Inc.||866-776-5907||neogenomics.com|
|PhenoPath, a Quest Diagnostics Company||888-927-4366||phenopath.com|
The Ion Torrent Oncomine Dx Target Test is the first targeted NGS-based in vitro diagnostic test for non-small cell lung cancer (NSCLC) and cholangiocarcinoma (CC), simultaneously delivering multiple biomarker results for multiple targeted therapies from one sample within four days.
|Cancer type||Gene||Targeted therapies|
|NSCLC||BRAF||TAFINLAR® (dabrafenib) in combination with MEKINIST® (trametinib)|
|EGFR, L858R and exon 19 deletions||IRESSA® (gefitinib)|
|EGFR exon 20 insertions|
Figure 1. List of genes for therapeutic use.
Technical and validation data for the Oncomine Dx Target Test ›
Gene targets included for NSCLC
|Gene targets for therapeutic use|
|BRAF: V600E||EGFR: L858R, exon 19 deletions, and exon 20 insertions||ROS1: fusions||RET: fusions|
|Analytically validated targets|
Figure 2. Complete gene list. *The test reports fusion/translocation variants for ROS1 and RET only. This test only reports mutations for ALK and MET. **Performance for the additional gene target variants has been validated based on a representative method. Only IDH1 is reported for CC.
Next-generation sequencing (NGS) can sequence hundreds to thousands of genes and detect multiple biomarkers at the same time. The sequencing takes place in a chip that contains millions of wells (flow cells) with separate sequencing reactions taking place in each well, allowing many genes to be sequenced at once and multiple variations to be detected simultaneously, unlike traditional companion diagnostic technologies such as FISH, IHC, or PCR, which only analyze one target gene at the time.
Figure 3. The NGS process starts with extraction of the DNA and/or RNA, which is processed in the chip in the Ion PGM Dx instrument, and results are analyzed and reported by a dedicated bioinformatics solution.
The Oncomine Dx Target Test Clinical Test Report is automatically generated as a PDF and incorporates relevant patient, sample, and test information required to help ensure high-performance standards, regulatory compliance, and quality control. The test results are presented in two-parts: companion diagnostic marker results with associated therapy indications and cancer driver analytical-only biomarker results in a separate section. The report is customizable and LIMS system-compatible.
Download an example of an Oncomine Dx Target Test report ›
NSCLC results for sequence variations for therapeutic use (for illustrative purposes only: EGFR, BRAF, ROS1, and RET are mutually exclusive)
Amino acid change
EGFR exon 20 insertions
TAFINLAR® + MEKINIST® (dabrafenib in combination with trametinib)
|RET||RET Fusions||POSITIVE||GAVRETO™ (pralsetinib)|
Amino acid change
Figure 4. An example of the Oncomine Dx Target Test report format. The report includes a section with results of the validated biomarkers and information about relevant treatment indication, as well as a section with the other biomarkers not validated for treatment selection (not shown).
Abbreviated Intended Use: The Oncomine Dx Target Test is a qualitative in vitro diagnostic test that uses targeted high-throughput, parallel-sequencing technology to detect single-nucleotide variants (SNVs), deletions, and insertions in 23 genes from DNA and fusions in ROS1 and RET from RNA isolated from formalin-fixed, paraffin-embedded (FFPE) tumor samples from patients with non-small cell lung cancer (NSCLC) and IDH1 R132 mutations from FFPE tumor tissue samples from patients with cholangiocarcinoma (CC) using the Ion PGM Dx System.
Test limitations and warnings
For In Vitro Diagnostic Use.