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21h
BRAF V600E Mutation in Malignant Melanoma-A Romanian Research Experience. (PubMed, Medicina (Kaunas))
BRAF V600E mutation was identified in 15 out of 40 secondary tumors with lymph node location (37.5%) and in 6 out of 15 secondary tumors with another location (40%) without statistically significant differences between the mutation frequency and the location of the secondary tumors. Our results support MM high genetic heterogeneity, pointing out the relationship between BRAF V600E mutation and several clinicopathological characteristics, in primary and metastatic MMs, stressing the importance of BRAF testing implementation in Romania.
Journal
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BRAF (B-raf proto-oncogene)
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BRAF V600E • BRAF V600 • ATM mutation
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Idylla™ BRAF Mutation Test
4ms
Biocartis hosts corporate workshop and announces seven Idylla™ abstracts to be presented at AMP 2023 annual meeting (Biocartis Press Release)
"Biocartis...announces that it will host a free corporate workshop at the Annual Meeting of the ‘Association for Molecular Pathology’ (AMP), a leading molecular diagnostics conference, taking place between 14-18 November 2023 in Salt Lake City, Utah (US)."
Clinical data
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Idylla™ BRAF Mutation Test • Idylla™ KRAS Mutation Test • Idylla™ MSI Test
5ms
Validation of Idyllaâ„¢ BRAF Mutation Assay for the detection of V600E/D and V600K/R/M mutations in patients with Advanced Melanoma. (AMP 2023)
The Idylla BRAF Mutation Assay is a highly reliable and sensitive platform for detecting BRAF pathogenic variants in codon 600 in malignant melanoma. The test can be performed in less than two hours, significantly improving turnaround time, thus allowing faster time to treatment.
Clinical • Metastases
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BRAF (B-raf proto-oncogene)
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BRAF V600E • BRAF V600 • BRAF V600K • BRAF wild-type • BRAF V600R • BRAF V600D • BRAF V600M
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Idylla™ BRAF Mutation Test
5ms
Melanin-Bleaching for Biocartis Idylla BRAF Mutation Assay for Pigmented Melanoma (AMP 2023)
Melanin bleaching can be a double-edged sword: The melanin may disappear, but the tissue's morphology and integrity of nuclear contents may be compromised. KMnOâ‚„ frequently compromises structural integrity and antigenicity in IHC. Thus, a gentler Hâ‚‚Oâ‚‚ treatment was selected for the molecular analysis of moderately/heavily pigmented melanomas.
BRAF (B-raf proto-oncogene) • SOX10 (SRY-Box 10)
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BRAF mutation
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Idylla™ BRAF Mutation Test
5ms
Case Series of BRAF V600E-mutant Acute Myeloid Leukemia (AML): A Possible Lethal Molecular Sub-group (AMP 2023)
The rapid demise of these two patients with BRAF V600E-mutant AML highlights their poor prognosis. Few cases of BRAF V600E-mutant AML have been described in the literature, all of which reported poor survival. Intriguingly, most cases exhibited monocytic morphology and concurrent KMT2A rearrangements, as was observed in case 2.
Clinical
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KRAS (KRAS proto-oncogene GTPase) • BRAF (B-raf proto-oncogene) • RUNX1 (RUNX Family Transcription Factor 1) • KMT2A (Lysine Methyltransferase 2A) • TET2 (Tet Methylcytosine Dioxygenase 2) • RUNX1T1 (RUNX1 Partner Transcriptional Co-Repressor 1) • ZRSR2 (Zinc Finger CCCH-Type, RNA Binding Motif And Serine/Arginine Rich 2)
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BRAF V600E • BRAF V600 • KMT2A rearrangement • KRAS G12A • KRAS G12 • MLL rearrangement • MLL rearrangement
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Idylla™ BRAF Mutation Test • TruSight Myeloid Sequencing Panel
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Mekinist (trametinib) • Tafinlar (dabrafenib)
11ms
RAS testing of circulating cell-free DNA (cfDNA) from tissue RAS/BRAF wild-type metastatic colorectal carcinoma (mCRC) patients: Preliminary data from the Liquid Biopsy Monoclonal Antibodies in mCRC (LIBImAb) study. (ASCO 2023)
Patients RASmut on liquid biopsy at baseline are randomized to receive FOLFIRI plus Cetuximab or FOLFIRI plus Bevacizumab... These preliminary data suggest that liquid biopsy might better recapitulate the heterogeneity of mCRC and might be useful in clinical practice to complement tissue testing. The clinical relevance of RAS variants detected in cfDNA will be determined in the LIBImAb trial.
Clinical • Liquid biopsy • Metastases • Biopsy
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KRAS (KRAS proto-oncogene GTPase) • BRAF (B-raf proto-oncogene) • NRAS (Neuroblastoma RAS viral oncogene homolog) • RAS (Rat Sarcoma Virus)
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KRAS mutation • BRAF mutation • NRAS mutation • BRAF V600 • BRAF wild-type • RAS mutation • RAS wild-type • KRAS exon 2 mutation • KRAS exon 3 mutation
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Idylla™ BRAF Mutation Test • Idylla™ KRAS Mutation Test
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Avastin (bevacizumab) • Erbitux (cetuximab) • 5-fluorouracil • irinotecan • leucovorin calcium
1year
KEBI-Cyto Study - Use of the Biocartis Idylla (clinicaltrials.gov)
P=N/A | N=55 | Completed | Sponsor: Royal Cornwall Hospitals Trust | Recruiting ➔ Completed | N=200 ➔ 55
Enrollment change • Trial completion
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EGFR (Epidermal growth factor receptor) • KRAS (KRAS proto-oncogene GTPase) • BRAF (B-raf proto-oncogene)
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KRAS mutation • EGFR mutation • BRAF mutation
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Idylla™ BRAF Mutation Test • Idylla™ EGFR Mutation Test • Idylla™ KRAS Mutation Test
1year
Analysis of cell-free tumor DNA in cerebrospinal fluid as a diagnostic biomarker for leptomeningeal melanoma metastasis: a case series (EADO 2023)
analysis for BRAFV600- and NRASQ61-mutant ctDNA on CSF using the Idylla® platform holds promise as a sensitive and specific complementary biomarker for the diagnosis of LMM, especially in cases with ambiguous imaging or CSF cytology results. The rapid (90 min) analysis of 1 ml of CSF, offering same day results, can be of important benefit, facilitating urgent treatment decisions.
Clinical • Circulating tumor DNA
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BRAF V600E • NRAS mutation • NRAS Q61 • NRAS Q61R
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Idylla™ BRAF Mutation Test
over1year
Panitumumab plus trifluridine/tipiracil as third-line anti-EGFR rechallenge therapy in chemo-refractory RAS WT metastatic colorectal cancer: The VELO randomized phase II clinical trial. (ASCO-GI 2023)
P2 | "This is the first prospective randomized trial which evaluated anti-EGFR monoclonal antibody (panitumumab) in addition to standard of care (trifluridine-tipiracil) as third-line rechallenge therapy in chemo-refractory RASWT mCRC patients. Baseline liquid biopsy allows selection of RAS/BRAF WT ctDNA patients who could have a relevant clinical benefit. Clinical trial information: NCT05468892."
P2 data • Clinical
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KRAS (KRAS proto-oncogene GTPase) • BRAF (B-raf proto-oncogene) • NRAS (Neuroblastoma RAS viral oncogene homolog)
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BRAF V600E • KRAS mutation • NRAS mutation • BRAF V600 • BRAF wild-type • RAS wild-type • EGFR S492R
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FoundationOne® Liquid CDx • Idylla™ BRAF Mutation Test • Idylla™ KRAS Mutation Test
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Vectibix (panitumumab) • Lonsurf (trifluridine/tipiracil)
over1year
Mutation status of full RAS and BRAF in 169 Moroccan patients with colorectal cancer. (ASCO-GI 2023)
Beside established anti-CRC treatment, better understanding of the causality of CRC can be established by combining epidemiology and genetic/epigenetic on CRC etiology in Morocco. This approach may be able to significantly reduce the burden of disease in the country. Moreover, the Moroccan government should develop policy on CRC prevention and public health programs which may serve as a feasible setting to increase public awareness on lifestyle risk factors.
Clinical
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KRAS (KRAS proto-oncogene GTPase) • BRAF (B-raf proto-oncogene) • NRAS (Neuroblastoma RAS viral oncogene homolog) • RAS (Rat Sarcoma Virus)
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BRAF V600E • KRAS mutation • KRAS G12C • BRAF mutation • NRAS mutation • BRAF V600 • KRAS G12D • RAS mutation • NRAS Q61K • KRAS G12 • NRAS Q61 • KRAS exon 2 mutation • NRAS G12D • NRAS G13 • KRAS exon 3 mutation • KRAS exon 4 mutation • KRAS Q61K
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Idylla™ BRAF Mutation Test • Idylla™ KRAS Mutation Test
over1year
Idylla BRAF and NRAS (AMP 2022)
"The 23 common mutations detected in the BRAF and NRAS genes using this assay have significant impact on therapeutic selection. Somatic variants in the BRAF gene have been found in 37%-50% of all malignant melanomas, whereas somatic variants in the NRAS gene are found in 13%-25% of all melanomas. The Biocartis Idylla system offers a simple and rapid method to obtain somatic mutation information in these two genes that are of clinical importance."
EGFR (Epidermal growth factor receptor) • BRAF (B-raf proto-oncogene) • NRAS (Neuroblastoma RAS viral oncogene homolog)
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EGFR mutation • NRAS mutation • BRAF V600 • NRAS Q61K • NRAS Q61 • NRAS Q61R • NRAS G13 • NRAS Q61L • EGFR S492R
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Idylla™ BRAF Mutation Test • Idylla™ EGFR Mutation Test • Idylla™ NRAS-BRAF-EGFR S492R Mutation Assay
over1year
Clinical
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KRAS (KRAS proto-oncogene GTPase) • BRAF (B-raf proto-oncogene) • NRAS (Neuroblastoma RAS viral oncogene homolog) • RAS (Rat Sarcoma Virus)
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BRAF mutation • NRAS mutation • BRAF V600 • RAS mutation
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Idylla™ BRAF Mutation Test • Idylla™ KRAS Mutation Test
almost2years
Concordance between RAS and BRAF mutational status determination in ctDNA and tissue in patients with mCRC (ESMO-GI 2022)
It is a minimally invasive method with a high degree of sensitivity and is representative of tumour heterogeneity. Future work is needed to evaluate cases with tissue-plasma discordance and the emerging monitoring of acquired mutations in RAS and BRAF as mechanisms of resistance.
Clinical • Circulating tumor DNA
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KRAS (KRAS proto-oncogene GTPase) • BRAF (B-raf proto-oncogene) • NRAS (Neuroblastoma RAS viral oncogene homolog) • RAS (Rat Sarcoma Virus)
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BRAF V600E • KRAS mutation • BRAF mutation • NRAS mutation • BRAF V600 • RAS mutation
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Idylla™ BRAF Mutation Test • Idylla™ KRAS Mutation Test
almost2years
Prognostic value of conversion from RAS-mutated to RAS wild-type during treatment of metastatic colorectal cancer using liquid biopsies – real-world data of two Portuguese institutions (ESMO-GI 2022)
Several clinicopathological factors were correlated with RAS-wt conversion, which may help select pts most likely to benefit from LB during treatment. Doing LB in pts with Ras-mut tumors should be considered, preferentially early in the disease-course, since loss of mutation represents an opportunity for treatment with anti-EGFR-therapy otherwise unlikely.
Real-world evidence • Clinical • Liquid biopsy
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BRAF (B-raf proto-oncogene) • RAS (Rat Sarcoma Virus)
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BRAF mutation • RAS mutation • RAS wild-type
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Idylla™ BRAF Mutation Test
almost2years
Phase III study to compare bevacizumab or cetuximab plus FOLFIRI in patients with advanced colorectal cancer RAS/BRAF wild type (wt) on tumor tissue and RAS mutated (mut) in liquid biopsy: LIBImAb Study. (ASCO 2022)
The primary endpoint is the PFS Plasma samples will be analyzed for KRAS, NRAS, and BRAF mutations by Idylla ctKRAS and Idylla ctNRAS-BRAF-EGFGR. All samples will be also analyzed by NGS, in order to better evaluate the correlation of tumor heterogeneity with pts’ outcomes.
P3 data • Clinical • Liquid biopsy
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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 wild-type
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Idylla™ BRAF Mutation Test • Idylla™ ctKRAS Mutation Test
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Avastin (bevacizumab) • Erbitux (cetuximab) • 5-fluorouracil • leucovorin calcium
almost2years
Improving care of melanoma patients through efficient, integrated cellular-molecular pathology workflows using tissue samples with low tumour nuclear content. (PubMed, J Clin Pathol)
"The Idylla BRAF test has the potential to make a significant positive impact on progression-free survival of malignant melanoma patients due to its rapid turnaround time. The Idylla BRAF test can be used as an adjunct to NGS for timely management of patients, particularly those with a poor performance status at presentation."
Journal
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BRAF (B-raf proto-oncogene)
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BRAF mutation
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Idylla™ BRAF Mutation Test
2years
Comparison of Two Rapid Assays for the Detection of BRAF V600 Mutations in Metastatic Melanoma including Positive Sentinel Lymph Nodes. (PubMed, Diagnostics (Basel))
"The agreement rate was 91% (72/79). Although the agreement rate was high, we suggest that the use of IHC is more suitable for rapid BRAF testing on sentinel lymph node biopsies when associated with a low percentage and scattered tumor cells, which gave a high risk of non-contributory analysis and/or false negative results with the IdyllaBRAF Mutation Test."
Journal
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BRAF (B-raf proto-oncogene)
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BRAF V600E • BRAF mutation • BRAF V600 • BRAF V600K
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Idylla™ BRAF Mutation Test • VENTANA anti-BRAF V600E (VE1) Mouse Monoclonal Primary Antibody
2years
Phenotype-Genotype Correlation in Colorectal Cancer: A Real-Life Study. (PubMed, GE Port J Gastroenterol)
"Our small sample size may be a limitation of the study. In our cohort, RAS-mutated tumours were associated with worse DFS and OS in early-stage CRC, whereas the remaining molecular variables had no prognostic influence."
Journal
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BRAF (B-raf proto-oncogene) • MSI (Microsatellite instability) • MLH1 (MutL homolog 1) • MSH6 (MutS homolog 6) • MSH2 (MutS Homolog 2) • PMS2 (PMS1 protein homolog 2)
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MSI-H/dMMR • BRAF mutation • BRAF wild-type • PMS2 mutation
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Idylla™ BRAF Mutation Test • Idylla™ MSI Test
2years
Rapid Idylla™ mutational testing: Current and future theranostic applications (PubMed, Ann Pathol)
In this article, we review the data about the fast and fully automated real-time PCR platform Idylla™ (Biocartis, Mechelen, Belgium) permitting the mutational analyses of BRAF, KRAS, NRAS, EGFR and microsatellite instability notably in melanoma, non-small-cell lung cancer and colorectal cancer samples. Future applications as well as the implementation of Idylla™ in the workflow of pathology and/or molecular biology laboratories are also discussed.
Journal
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EGFR (Epidermal growth factor receptor) • KRAS (KRAS proto-oncogene GTPase) • BRAF (B-raf proto-oncogene) • NRAS (Neuroblastoma RAS viral oncogene homolog) • MSI (Microsatellite instability)
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KRAS mutation • EGFR mutation • BRAF mutation • NRAS mutation
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Idylla™ BRAF Mutation Test • Idylla™ EGFR Mutation Test • Idylla™ KRAS Mutation Test • Idylla™ MSI Test
over2years
[VIRTUAL] Use of Intra-Gross Examination Touch Prep Slides to Facilitate Turn-around Time (TAT) Advantage Using the Biocartis Idylla (AMP 2021)
The aim of our study was to investigate the use of TPs on the Idylla system to reduce TATs, such that results would be available with routine surgical pathology reports. Our approach of collecting TP samples directly from tissue and testing them via the Idylla system significantly reduced potential TATs. Samples processed with rapid intent often provided results the same day as or before the pathology report release.
MSi-H Biomarker
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EGFR (Epidermal growth factor receptor) • KRAS (KRAS proto-oncogene GTPase) • BRAF (B-raf proto-oncogene) • NRAS (Neuroblastoma RAS viral oncogene homolog) • MSI (Microsatellite instability)
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KRAS mutation • EGFR mutation • MSI-H/dMMR • BRAF mutation • EGFR positive
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Idylla™ BRAF Mutation Test • Idylla™ EGFR Mutation Test • Idylla™ KRAS Mutation Test • Idylla™ MSI Test
over2years
[VIRTUAL] Validation of a Rapid PCR-Based Assay for BRAF V600 Status for Prognostication and Therapeutic Selection in Colorectal Cancer Patients (AMP 2021)
Our results demonstrate that the Idylla BRAF Mutation Assay produces accurate, precise results in less than 3 hours, with faster TAT compared to NGS. Single-use cartridges eliminate the need for manual sample preprocessing and the risk of PCR contamination. In addition, this sensitive assay correctly identifies BRAF V600 alterations in samples with necrosis and low tumor cell content.
Clinical
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BRAF (B-raf proto-oncogene) • NRAS (Neuroblastoma RAS viral oncogene homolog)
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BRAF V600E • NRAS mutation • BRAF V600 • BRAF V600K • BRAF K601E • BRAF L597Q • BRAF V600R • BRAF K601 • BRAF L597
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Idylla™ BRAF Mutation Test • Idylla™ NRAS-BRAF Mutation Test • TruSight Tumor 170 Assay
over2years
[VIRTUAL] Validation of the Biocartis Idylla System for BRAF and KRAS mu- tations in formalin fixed tissues (ECP 2021)
The study has shown a 46% mutation rate for KRAS muta- tions in NSCLC samples, and with a KRAS G12C inhibitor on the hori- zon we have shown that it is feasible to use KRAS testing as a screening tool and for treatment stratification purposes in parallel. Results from the BRAF validation demonstrate the ability to detect mutations in the BRAF gene in a number of tissue types.
KRAS (KRAS proto-oncogene GTPase) • BRAF (B-raf proto-oncogene)
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BRAF V600E • KRAS mutation • BRAF V600 • KRAS G12D • KRAS G12V • BRAF V600K • KRAS G12A • KRAS Q61H • KRAS exon 2 mutation
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Idylla™ BRAF Mutation Test • Idylla™ KRAS Mutation Test
over2years
[VIRTUAL] Liquid biopsy driven anti-EGFR rechallenge in metastatic colorectal cancer (ESMO 2021)
The liquid biopsy driven rechallenge strategy with anti-EGFR confirmed to be feasible in clinical practice. The clinical outcome resulted consistent with the literature data. In addition to the molecular selection through the analysis of ct-DNA for RAS, the long anti-EGFR free interval is confirmed as a prospective selection criterion for this therapeutic option.
Liquid biopsy
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BRAF (B-raf proto-oncogene)
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BRAF mutation
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Idylla™ BRAF Mutation Test
almost3years
[VIRTUAL] Circulating tumor DNA mutation as a prognostic marker in melanoma with brain metastasis. (ASCO 2021)
Plasma-based, rapid ctDNA testing may be useful as an aid in detecting progression and gauging prognosis in patients with melanoma treated in the metastatic setting . The dynamics of ctDNA test positivity may indicate a need for more urgent imaging, particularly of the brain . Blood-based, semi-automated ctDNA detection may serve as an attractive adjunct to scheduled imaging surveillance in melanoma.
Circulating tumor DNA
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BRAF (B-raf proto-oncogene)
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BRAF mutation
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Idylla™ BRAF Mutation Test
almost3years
[VIRTUAL] The temporal evaluation of RAS and BRAF mutation by liquid biopsy at progression after bevacizumab combinations in patients with metastatic colorectal cancer (mCRC). (ASCO 2021)
This study demonstrated that there may be changes in RAS/BRAF mutation from plasma analysis after progression in patients with mCRC . Since better survival in the patient group with wild type was detected compared to the RAS concordance group, the evaluation of RAS mutation status at the time of progression may be important in terms of disease prognosis and treatment options.
Clinical • Liquid biopsy
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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
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Idylla™ BRAF Mutation Test • Idylla™ EGFR Mutation Test • Idylla™ KRAS Mutation Test
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Avastin (bevacizumab)
almost3years
[VIRTUAL] Liquid biopsy-driven anti-EGFR rechallenge in patients with metastatic colorectal cancer. (ASCO 2021)
In details 11 patients (78.6%) underwent irinotecan+ cetuximab treatment, whereas 3 patients (21.4%) underwent panitumumab monotherapy . The rechallenge strategy with anti-EGFR confirmed to be feasible in clinical practice . The clinical outcome resulted consistent with the literature data . In addition to the molecular selection through the analysis of ct-DNA for RAS, previous response to anti EGFR treatment is confirmed as a prospective selection criteria for this therapeutic option.
Clinical • Liquid biopsy
|
KRAS (KRAS proto-oncogene GTPase) • BRAF (B-raf proto-oncogene)
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KRAS mutation • BRAF mutation
|
Idylla™ BRAF Mutation Test • Idylla™ EGFR Mutation Test • Idylla™ KRAS Mutation Test
|
Erbitux (cetuximab) • Vectibix (panitumumab) • irinotecan
over3years
Detection of BRAF V600E Mutation in Ganglioglioma and Pilocytic Astrocytoma by Immunohistochemistry and Real-Time PCR-Based Idylla Test. (PubMed, Dis Markers)
"This included 2 cases of GG and 5 cases of PA. Our study found that BRAF V600E mutations are moderately frequent in PA and GG and that for these tumor entities, IHC VE1 is suitable for screening purposes, but all negative, equivocal, and weak positive cases should be further tested with molecular biology techniques, of which the Idylla system seems to be a promising tool."
Journal
|
BRAF (B-raf proto-oncogene)
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BRAF V600E • BRAF V600
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Idylla™ BRAF Mutation Test • VENTANA anti-BRAF V600E (VE1) Mouse Monoclonal Primary Antibody
over5years
Preclinical • Trial completion date • Metastases
|
BRAF (B-raf proto-oncogene)
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BRAF mutation • BRAF V600 • BRAF wild-type
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Idylla™ BRAF Mutation Test
|
Zelboraf (vemurafenib) • Cotellic (cobimetinib)