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TEST:
Oncomine™ Colon cfDNA Assay

Type:
Laboratory Developed Test
Related tests:
Evidence

News

5ms
Early changes in circulating tumor DNA (ctDNA) predict treatment response in metastatic KRAS-mutated colorectal cancer (mCRC) patients. (PubMed, Heliyon)
In selected cases, co-mutations were able to better anticipate radiological progressive disease (PD) than the increase of KRAS-mutated clones. In conclusion, our study confirms plasma ctDNA as a crucial tool for anticipating PD at an early time point and highlights the value of a comprehensive assessment of clonal dynamics to improve the management of patients with mCRC.
Journal • Circulating tumor DNA • Metastases
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KRAS (KRAS proto-oncogene GTPase) • TP53 (Tumor protein P53) • PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha) • FBXW7 (F-Box And WD Repeat Domain Containing 7) • GNAS (GNAS Complex Locus)
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TP53 mutation • KRAS mutation • PIK3CA mutation • RAS mutation
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CELLSEARCH® • Oncomine™ Colon cfDNA Assay
8ms
Dynamic Monitoring of Circulating Tumor DNA in Patients With Metastatic Colorectal Cancer. (PubMed, JCO Precis Oncol)
ctDNA analysis is useful for molecular characterization and tumor response monitoring in patients with mCRC. Quantitative variations of released ctDNA are associated with clinical outcomes.
Journal • Circulating tumor DNA • Metastases
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KRAS (KRAS proto-oncogene GTPase) • BRAF (B-raf proto-oncogene) • PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha) • NRAS (Neuroblastoma RAS viral oncogene homolog)
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KRAS mutation • BRAF mutation • NRAS mutation • PIK3CA mutation
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Oncomine™ Colon cfDNA Assay
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Avastin (bevacizumab)
10ms
THE YIELD OF NEXT GENERATION SEQUENCING IN DIAGNOSTIC WORK UP OF SUSPICIOUS BILIARY STRICTURES (UEGW 2023)
There is a significant additional yield of NGS in the setting of biliary strictures. Nevertheless, NGS has a limited impact on clinical decision making and for now should only be used in patients in which the outcome is most valuable. This could be to differentiate between different causes of cancer to determine the optimal chemotherapy regimen, or in patients with a clinical suspicion of malignancy but without any mass on cross-sectional imaging.
Next-generation sequencing
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Oncomine™ Colon cfDNA Assay
1year
Circulating tumor DNA in colorectal cancer patients with resectable liver metastases: Preliminary results of the MIRACLE study (AACR 2023)
ctDNA is a potential biomarker to detect MRD after curative treatment for CRLM. Our results demonstrate that out of all patients with detectable ctDNA at baseline (before surgery), ctDNA is still present in 36% of patients three weeks after resection.
Clinical • Tumor mutational burden • Circulating tumor DNA
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KRAS (KRAS proto-oncogene GTPase) • BRAF (B-raf proto-oncogene) • TP53 (Tumor protein P53) • PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha) • TMB (Tumor Mutational Burden)
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BRAF mutation • PIK3CA mutation
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Oncomine™ Colon cfDNA Assay
1year
Use of liquid biopsy for detection of pathogenic variants in cell-free tumor DNA from patients with precursor lesions and colorectal cancer (AACR 2023)
The detection of variants in liquid biopsy demonstrates the potential for non-invasive early screening and diagnostic of CRC.
Clinical • Liquid biopsy • Circulating tumor DNA • Biopsy
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KRAS (KRAS proto-oncogene GTPase) • BRAF (B-raf proto-oncogene) • TP53 (Tumor protein P53) • PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha) • MAP2K1 (Mitogen-activated protein kinase kinase 1) • SMAD4 (SMAD family member 4) • FBXW7 (F-Box And WD Repeat Domain Containing 7) • GNAS (GNAS Complex Locus)
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Oncomine™ Colon cfDNA Assay
over1year
PROSPECTIVE EVALUATION OF EMERGENT RAS AND BRAF MUTATIONS IN PRETREATED METASTATIC COLORECTAL CANCER PATIENTS CANDIDATE TO ANTIEGFR RE-TREATMENT: PRELIMINARY FINDINGS FROM THE PARERE STUDY (AIOM 2022)
We are now conducting a phase II randomized study, PARERE, to compare panitumumab followed by regorafenib versus the reverse sequence as treatment strategy in anti-EGFR pre-treated chemorefractory pts with RAS/BRAF wt ctDNA. This is the largest series of pts prospectively screened for anti-EGFR re-tx. Around one out of 3 pts bear RAS or BRAF mutations in their ctDNA. Anti-EGFR free interval is not a valuable surrogate of ctDNA mutational status, thus supporting liquid biopsy as a selection tool for clinical trials in this setting and for the use of anti-EGFR re-tx in the real life.
Clinical
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HER-2 (Human epidermal growth factor receptor 2) • KRAS (KRAS proto-oncogene GTPase) • BRAF (B-raf proto-oncogene) • TP53 (Tumor protein P53) • PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha) • NRAS (Neuroblastoma RAS viral oncogene homolog) • SMAD4 (SMAD family member 4) • CTNNB1 (Catenin (cadherin-associated protein), beta 1) • FBXW7 (F-Box And WD Repeat Domain Containing 7) • RAS (Rat Sarcoma Virus) • GNAS (GNAS Complex Locus)
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BRAF V600E • BRAF mutation • BRAF V600 • BRAF wild-type • RAS mutation
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Oncomine™ Colon cfDNA Assay
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Vectibix (panitumumab) • Stivarga (regorafenib)
over1year
Prospective evaluation of emergent RAS and BRAF mutations in pre-treated metastatic colorectal cancer patients candidate to anti-EGFR re-treatment: Preliminary findings from the PARERE study (ESMO 2022)
We are now conducting a phase II randomized study, PARERE, to compare panitumumab followed by regorafenib versus the reverse sequence as treatment strategy in anti-EGFR pre-treated chemorefractory pts with RAS/BRAF wt ctDNA. About 1 out of 3 pts bear RAS or BRAF mut in their ctDNA. Anti-EGFR free interval is not a valuable surrogate of ctDNA mut status, thus supporting liquid biopsy as a selection tool for clinical trials in this setting and for the use of anti-EGFR re-tx in the real life.
Clinical
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HER-2 (Human epidermal growth factor receptor 2) • KRAS (KRAS proto-oncogene GTPase) • BRAF (B-raf proto-oncogene) • TP53 (Tumor protein P53) • PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha) • NRAS (Neuroblastoma RAS viral oncogene homolog) • SMAD4 (SMAD family member 4) • CTNNB1 (Catenin (cadherin-associated protein), beta 1) • FBXW7 (F-Box And WD Repeat Domain Containing 7) • RAS (Rat Sarcoma Virus) • GNAS (GNAS Complex Locus)
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BRAF V600E • BRAF mutation • BRAF V600 • BRAF wild-type • RAS mutation
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Oncomine™ Colon cfDNA Assay
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Vectibix (panitumumab) • Stivarga (regorafenib)
almost2years
Circulating tumor DNA in metastatic colorectal cancer: Real-time monitoring of disease evolution and treatment response (ESMO-GI 2022)
In this retrospective exploratory study, we evaluated the utility of ctDNA analysis in a series of 53 mCRC patients treated with chemotherapy plus bevacizumab in first-line...Conclusions The mutational analysis performed on ctDNA is useful for mCRC molecular characterization, and quantitative variations of released ctDNA are associated with clinical outcomes. Together these results support the use of liquid biopsy for both molecular characterization and tumor response monitoring in mCRC patients.
Circulating tumor DNA
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KRAS (KRAS proto-oncogene GTPase) • BRAF (B-raf proto-oncogene) • NRAS (Neuroblastoma RAS viral oncogene homolog)
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KRAS mutation • BRAF mutation • NRAS mutation • BRAF wild-type • RAS mutation
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Oncomine™ Colon cfDNA Assay
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Avastin (bevacizumab)
3years
[VIRTUAL] Circulating tumor DNA variant allelic fraction as a surrogate for disease burden estimation in patients with RAS wild-type metastatic colorectal cancer: A secondary endpoint of the VALENTINO study (ESMO-GI 2021)
"A research grant and drug supply during panitumumab-based maintenance treatment was provided by Amgen...We identified 15.32% as the optimal VAF cut off for survival prediction. Conclusions ctDNA VAF should be prospectively investigated as a prognostic marker and may be useful for estimating disease burden compared to physician experience, CEA and CT scans."
Clinical • Circulating tumor DNA
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TP53 (Tumor protein P53) • PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha) • MAP2K1 (Mitogen-activated protein kinase kinase 1) • SMAD4 (SMAD family member 4) • FBXW7 (F-Box And WD Repeat Domain Containing 7)
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TP53 mutation • PIK3CA mutation • APC mutation
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Oncomine™ Colon cfDNA Assay
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5-fluorouracil • Vectibix (panitumumab) • leucovorin calcium