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2ms
Validation of Idylla MSI and BRAF genotype tests on archival colorectal cancer samples for retrospective Lynch syndrome detection. (PubMed, Virchows Arch)
This is the largest study evaluating Idylla on archival FFPE material. High concordance with traditional methods suggests that Idylla can be used as an alternative approach for Lynch syndrome screening, improving accessibility and reliability of MSI and BRAF testing in challenging archival specimens.
Retrospective data • Journal • MSi-H Biomarker
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BRAF (B-raf proto-oncogene) • MSI (Microsatellite instability)
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MSI-H/dMMR
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Idylla™ BRAF Mutation Test • Idylla™ MSI Test
9ms
Press Release Biocartis NV: Biocartis Announces Multiple Abstracts Demonstrating the Impact of Idylla in Oncology Diagnostics to be Presented at USCAP 2025 Annual Meeting (GlobeNewswire)
"Seven abstracts from leading research and academic institutions will be presented as posters, highlighting the rapid, fully automated molecular testing capabilities of the Idylla Platform across several different cancer types, including lung cancer, thyroid cancer, endometrial carcinoma and colorectal cancer. Biocartis also continues to focus on melanoma, blood, brain and breast cancer."
Clinical data
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AmoyDx® Pan Lung Cancer PCR Panel • Idylla™ GeneFusion Assay • Idylla™ BRAF Mutation Test • Idylla™ EGFR Mutation Test • Idylla™ KRAS Mutation Test • Idylla™ MSI Test
9ms
BRAF p.V600E-Negative Langerhans Cell Histiocytosis Associated with a Periapical Cyst: A Case Presentation with Broad Review of the Differential Diagnosis and Disease Pathophysiology. (PubMed, Head Neck Pathol)
The association of LCH with a periapical cyst could be explained by the active surveillance and migration of neoplastic Langerhans-type cells in blood to the site of apical chronic inflammation, in a patient with LCH. Careful attention to morphologic features in conjunction with Langerin IHC, helps exclude other closely-related dendritic tumours. BRAF p. V600E testing, ideally with real-time PCR assays, can help identify patients who may benefit from BRAF inhibitor therapies. New generations of sequencing that cover a large panel of genetic alterations beyond the frequent BRAF p. V600E mutations (e.g. rare in-frame BRAF deletions), could provide valuable information about the extent, prognosis and treatment of LCH patients.
Review • Journal
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BRAF (B-raf proto-oncogene)
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BRAF V600E • CD20 positive
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Idylla™ BRAF Mutation Test
over1year
An Automated Real-Time PCR Assay versus Next-Generation Sequencing in the Detection of BRAF V600 Mutations in Melanoma Tissue Samples. (PubMed, Diagnostics (Basel))
IdyllaTM testing proved to be a reliable and rapid alternative to NGS in the determination of BRAF V600 mutation. Although BRAF. status was available earlier, this had no influence on the treatment decision in most cases.
Journal • IO biomarker • Next-generation sequencing
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BRAF (B-raf proto-oncogene)
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Idylla™ BRAF Mutation Test
over1year
Comparison Between EGFR PCR Alone and NGS with Gene Fusion PCR for Detecting Oncogenic Driver Alteration in Thai NSCLC Patients (IASLC-WCLC 2024)
However, NGS had a 12-day longer TAT compared to EGFR PCR. Gene fusion-panel PCR and NGS identified an additional 11.6% of patients harboring actionable alterations who may benefit from FDA-approved targeted therapies.
Clinical • Next-generation sequencing
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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) • MET (MET proto-oncogene, receptor tyrosine kinase) • RET (Ret Proto-Oncogene) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS)
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BRAF V600E • KRAS mutation • EGFR mutation • KRAS G12C • EGFR L858R • EGFR exon 19 deletion • EGFR T790M • RET fusion • MET exon 14 mutation • ALK fusion • ROS1 fusion • EGFR G719X • KRAS G12 • EGFR positive • EGFR L747P • EGFR L861R
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cobas® EGFR Mutation Test v2 • Idylla™ GeneFusion Assay • Idylla™ BRAF Mutation Test • Idylla™ EGFR Mutation Test
over1year
BRAF V600E Expression in Colon Cancer: Evaluation According to KRAS Mutation Status (AMP Europe 2024)
Our results suggest that total loss of BRAF in patients with CRC is more likely to be observed in patients with KRAS mutation. A correlation with molecular BRAF status is necessary to definitively assess the benefit of BRAF IHC as an indicative method of BRAF and KRAS status in CRC which could be used as a first alternative in countries with low income.
KRAS (KRAS proto-oncogene GTPase) • BRAF (B-raf proto-oncogene)
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Idylla™ BRAF Mutation Test
over1year
Resolving Discrepancies in Idylla BRAF Mutational Assay Results Using Targeted Next-Generation Sequencing. (PubMed, Genes (Basel))
Regardless, we recommend that Idylla BRAF cases with non-classical amplification curves undergo reflex NGS testing. These findings are likely relevant for other Idylla assays interrogating hotspot mutations in genes such as EGFR, IDH1/2, KRAS, and NRAS.
Journal • Retrospective data • Next-generation sequencing
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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) • IDH1 (Isocitrate dehydrogenase (NADP(+)) 1) • IDH2 (Isocitrate Dehydrogenase (NADP(+)) 2)
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Idylla™ BRAF Mutation Test
over1year
Circulating tumor DNA analysis in patients with BRAF-mutated metastatic cutaneous melanoma treated with BRAF and MEK inhibitors: Analysis of the OPTIMEL study. (ASCO 2024)
This report presents the initial analysis of the OPTIMEL study. The variant allele frequency of BRAF mutations in circulating tumor DNA is indicative of the objective response to BRAF and MEK inhibitors, as well as PFS. These findings could potentially influence our approach to managing patients with MM harboring a BRAF mutation.
Clinical • Circulating tumor DNA • Metastases
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NRAS (Neuroblastoma RAS viral oncogene homolog)
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Idylla™ BRAF Mutation Test
over1year
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
2years
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
2years
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
2years
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)