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TEST:
Oncomine Dx Express Test

Type:
CE Marked
Related tests:
Evidence

News

23d
Analytical validation of the Oncomine™ Dx Express Test using liquid biopsy samples as an IUO assay in a CAP/CLIA lab (AACR 2024)
This validation study to estimate analytical accuracy, limit of detection, variant calling accuracy and precision has demonstrated that the ODxET assay is highly robust in detecting SNV and INDEL mutations in plasma samples and is suitable for use in a CAP/CLIA laboratory as an IUO assay.**=In Vitro Diagnostic use only. Not available in all regions including North America.
Liquid biopsy • Biopsy
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Oncomine Dx Express Test
23d
Analytical performance of the Oncomine™ Dx Express Test, a CE-IVD NGS liquid biopsy assay for identification of clinically relevant variants (AACR 2024)
The analytical accuracy study shows the false positive rate at 0.20% for SNVs, 0% for indel locations and fusion targets. In addition, the analytical reproducibility study shows 99.64% intra-run repeatability call rate for DNA variants and 98.75% for RNA variants.ConclusionIn conclusion, we establish that the ODxET assay on Ion Torrent Genexus Dx Integrated Sequencer, is fast and efficient while demonstrating high sensitivity, specificity, and reproducibility for testing NSCLC liquid biopsy samples.
Clinical • Liquid biopsy • Next-generation sequencing • Biopsy
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Oncomine Dx Express Test
5ms
Thermo Fisher Scientific Signs Companion Diagnostic Agreement with Boehringer Ingelheim to Select Patients with NSCLC for Targeted Therapy Treatment (Businesswire)
"To support emerging precision therapies and improve patient outcomes by increasing access to reliable genomic testing needed to match patients with targeted cancer treatments, Thermo Fisher Scientific today announced a companion diagnostic (CDx) partnership with Boehringer Ingelheim. Through this collaboration, the companies will work to develop CDx tests to help identify patients with non-small cell lung cancer (NSCLC) with specific genomic mutations....The collaboration will leverage the Oncomine Dx Express Test on the Ion Torrent Genexus Dx System as well as the Oncomine Dx Target Test."
Licensing / partnership
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Oncomine Dx Express Test
6ms
European Real-World Assessment of the Clinical Validity of a CE-IVD Panel for Ultra-Fast Next-Generation Sequencing in Solid Tumors. (PubMed, Int J Mol Sci)
The test detected all the expected ALK, RET, NTRK1, and ROS1 fusion isoforms and MET exon 14-skipping splice variants. The average TAT from extracted nucleic acids to the final variant report was 18.3 h. The Oncomine Dx Express Test in combination with the Ion Torrent Genexus System is a CE-IVD-compliant, performant, and multicenter reproducible method for NGS detection of actionable biomarkers from a range of tumor samples, providing results in a short TAT that could support timely decision- making for targeted therapeutic interventions.
Real-world evidence • Journal • Clinical • Next-generation sequencing • Real-world
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ALK (Anaplastic lymphoma kinase) • MET (MET proto-oncogene, receptor tyrosine kinase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS) • NTRK1 (Neurotrophic tyrosine kinase, receptor, type 1)
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NTRK1 fusion • MET exon 14 mutation • ROS1 fusion • ALK-ROS1 fusion
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Oncomine Dx Express Test
11ms
Oncomine Dx Express CE-IVD liquid biopsy assay for non-small cell lung cancer: Performance review and analytical validation. (ASCO 2023)
Here, we demonstrated that the ODxET workflow on Genexus Dx Integrated Sequencer is a fast and efficient tool for testing clinical NSCLC liquid biopsy samples with high sensitivity and specificity.
Review • Liquid biopsy • Biopsy
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EGFR (Epidermal growth factor receptor) • HER-2 (Human epidermal growth factor receptor 2) • KRAS (KRAS proto-oncogene GTPase) • BRAF (B-raf proto-oncogene) • ALK (Anaplastic lymphoma kinase) • RET (Ret Proto-Oncogene) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS) • NTRK1 (Neurotrophic tyrosine kinase, receptor, type 1) • NTRK3 (Neurotrophic tyrosine kinase, receptor, type 3) • NTRK2 (Neurotrophic tyrosine kinase, receptor, type 2)
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BRAF V600E • KRAS G12C • BRAF V600 • NTRK1 fusion • NTRK2 fusion • EGFR exon 19 deletion • EGFR T790M • EGFR exon 20 insertion • ALK fusion • EGFR exon 19 deletion + EGFR T790M • KRAS G12 • EGFR exon 20 mutation • HER-2 exon 23 mutation • KRAS deletion
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Oncomine Dx Express Test
1year
Oncomine™ dx express CE-IVD liquid biopsy assay for non-small cell lung cancer: Performance review and analytical validation (AACR 2023)
In the analytical reproducibility study, the average with-in run repeatability call rate (No Calls excluded) was 99.64% for DNA variants and 98.75% for RNA variants.Conclusion - Here, we demonstrated that the ODxET workflow on Genexus™ Dx Integrated Sequencer is a fast and efficient tool for testing clinical NSCLC liquid biopsy samples with high sensitivity and specificity.For in vitro diagnostic use. Not available in all regions including the United States.
Review • Liquid biopsy • Biopsy
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EGFR (Epidermal growth factor receptor) • HER-2 (Human epidermal growth factor receptor 2) • KRAS (KRAS proto-oncogene GTPase) • BRAF (B-raf proto-oncogene) • ALK (Anaplastic lymphoma kinase) • RET (Ret Proto-Oncogene) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS) • NTRK1 (Neurotrophic tyrosine kinase, receptor, type 1) • NTRK3 (Neurotrophic tyrosine kinase, receptor, type 3) • NTRK2 (Neurotrophic tyrosine kinase, receptor, type 2)
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BRAF V600E • KRAS G12C • BRAF V600 • NTRK1 fusion • NTRK2 fusion • EGFR exon 19 deletion • EGFR T790M • EGFR exon 20 insertion • ALK fusion • EGFR exon 19 deletion + EGFR T790M • KRAS G12 • EGFR exon 20 mutation • HER-2 exon 23 mutation • KRAS deletion
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Oncomine Dx Express Test
1year
Thermo Fisher Scientific Partners with AstraZeneca to Develop Solid Tissue and Blood-Based Companion Diagnostic Test for Tagrisso (Thermo Fisher Scientific Press Release)
"As part of a global, multiyear agreement, Thermo Fisher Scientific today announced it is working with AstraZeneca to develop a solid tissue and blood-based companion diagnostic (CDx) test for Tagrisso (osimertinib). The CDx will help identify patients with non-small cell lung cancer (NSCLC) who may be eligible for treatment with Tagrisso by identifying tumors that exhibit epidermal growth factor receptor (EGFR) alterations including exon 21 L858R mutations, exon 19 deletions or T790M mutations. The collaboration will leverage the Oncomine Dx Express Test on the Genexus Dx System, a fully-integrated next-generation sequencing (NGS) platform featuring an automated specimen-to-report workflow that economically delivers results in as little as 24 hours to bring test results to clinicians and patients faster."
Licensing / partnership
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Oncomine Dx Express Test
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Tagrisso (osimertinib)
over1year
Thermo Fisher Scientific Launches CE-IVD (IVDD) Next-Generation Sequencing Test and Analysis Software to Expand Access to Precision Oncology Biomarker Testing (Businesswire)
"...Thermo Fisher Scientific today launched the CE-IVD (IVDD) Oncomine Dx Express Test and Oncomine Reporter Dx for use in clinical labs....Using targeted NGS technology, the Oncomine Dx Express Test delivers clinically relevant tumor mutation profiling in as little as 24 hours to aid healthcare professionals, in accordance with professional guidelines, in therapy management of cancer patients. This assay also detects deletions, insertions, substitutions in 42 genes and fusions or splicing variants in seven genes from cfTNA extracted from plasma samples of non-small cell lung cancer (NSCLC)."
Launch
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Oncomine Dx Express Test