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    TEST:
    Oncomine™ Colon cfDNA Assay

    Company:
    Thermo Fisher Scientific
    Type:
    Laboratory Developed Test
    Related tests:
    Details
    Evidence

    News

    3ms
    Clinical validation of liquid biopsy-RECIST (LB-RECIST) in metastatic colorectal cancer (mCRC) patients: findings from the PLATFORM-B study. (PubMed, ESMO Open)
    LB-RECIST is prognostic and predictive of clinical outcomes in frontline mCRC. The clinical utility of LB-RECIST to guide early treatment decisions is warranted through interventional trials.
    Journal • Liquid biopsy
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    Oncomine™ Colon cfDNA Assay
    12ms
    Plasma mutation profile of precursor lesions and colorectal cancer using the Oncomine Colon cfDNA Assay. (PubMed, BMC Cancer)
    The detection of plasma NGS-identified mutations could assist in early screening and diagnostic of CRC in a noninvasive manner.
    Journal
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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) • TP53 (Tumor protein P53) • PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha) • NRAS (Neuroblastoma RAS viral oncogene homolog) • MAP2K1 (Mitogen-activated protein kinase kinase 1) • AKT1 (V-akt murine thymoma viral oncogene homolog 1) • SMAD4 (SMAD family member 4) • CTNNB1 (Catenin (cadherin-associated protein), beta 1) • FBXW7 (F-Box And WD Repeat Domain Containing 7) • APC (APC Regulator Of WNT Signaling Pathway) • GNAS (GNAS Complex Locus)
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    Oncomine™ Colon cfDNA Assay
    over1year
    Third line rechallenge with cetuximab (Cet) and irinotecan in circulating tumor DNA (ctDNA) selected metastatic colorectal cancer (mCRC) patients: The randomized phase II CITRIC trial (ESMO 2024)
    Background: In the management of mCRC after progression on irinotecan and oxaliplatin, therapeutic options offer marginal benefit, typically yielding response rates from 1-6%. The CITRIC study is the first randomized trial assessing the efficacy of liquid biopsy for driving anti-EGFR rechallenge in the third line setting. Our preliminary results demonstrate the effectiveness of Cet rechallenge in terms of ORR and DCR and might be considered a treatment option for RAS/BRAF/EGFR-ECD wt ctDNA pts. We will present updated efficacy data at congress.
    P2 data • Clinical • Circulating tumor DNA • Metastases
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    BRAF (B-raf proto-oncogene) • RAS (Rat Sarcoma Virus)
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    BRAF V600E • BRAF V600 • RAS wild-type
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    Oncomine™ Colon cfDNA Assay
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    Erbitux (cetuximab) • oxaliplatin • irinotecan
    over1year
    Circulating tumor cells and tumor DNA in patients with resectable colorectal liver metastases: The MIRACLE. (ASCO 2024)
    This is the first study conducted in patients with resectable CRLM without (neo)adjuvant chemotherapy, which demonstrates the impact of detectable circulating tumor load after surgery on RFS. Postoperative ctDNA and CTC detection are a strong predictor for a shorter RFS after local treatment, as opposed to preoperative ctDNA or CTC detection.
    Clinical • Circulating tumor cells • Tumor cell
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    CELLSEARCH® • Oncomine™ Colon cfDNA Assay
    2years
    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
    over2years
    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)
    |
    KRAS mutation • BRAF mutation • NRAS mutation • PIK3CA mutation
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    Oncomine™ Colon cfDNA Assay
    |
    Avastin (bevacizumab)
    over2years
    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
    over2years
    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)
    |
    BRAF mutation • PIK3CA mutation
    |
    Oncomine™ Colon cfDNA Assay
    over2years
    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)
    |
    Oncomine™ Colon cfDNA Assay
    3years
    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
    |
    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
    |
    Oncomine™ Colon cfDNA Assay
    |
    Vectibix (panitumumab) • Stivarga (regorafenib)
    over3years
    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
    |
    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)
    |
    BRAF V600E • BRAF mutation • BRAF V600 • BRAF wild-type • RAS mutation
    |
    Oncomine™ Colon cfDNA Assay
    |
    Vectibix (panitumumab) • Stivarga (regorafenib)
    over3years
    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
    |
    KRAS (KRAS proto-oncogene GTPase) • BRAF (B-raf proto-oncogene) • NRAS (Neuroblastoma RAS viral oncogene homolog)
    |
    KRAS mutation • BRAF mutation • NRAS mutation • BRAF wild-type • RAS mutation
    |
    Oncomine™ Colon cfDNA Assay
    |
    Avastin (bevacizumab)