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4ms
Phase classification • Liquid biopsy • IO biomarker
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BRAF (B-raf proto-oncogene)
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InVisionFirst®-Lung
12ms
LIBELULE: a randomized phase III study to evaluate the clinical relevance of early liquid biopsy in patients with suspicious metastatic lung cancer. (PubMed, J Thorac Oncol)
P3; Early liquid biopsy testing did not significantly shorten the TTI in unselected patients referred for suspected advanced lung cancer. Nevertheless, it could reduce the TTI in patients eligible for systemic treatment, particularly for those with actionable alterations.
Journal • P3 data • Liquid biopsy • Metastases • Biopsy
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InVisionFirst®-Lung
over1year
NeoGenomics to Introduce Comprehensive Lung Solution & Feature Hematopathology Services at ASCO, Offering Actionable Insights to Support Treatment Management (GlobeNewswire)
"NeoGenomics, Inc...will showcase its versatile lung solution and its COMPASS Hematopathology Services portfolio at the American Society of Clinical Oncology (ASCO) conference in Chicago, May 31–June 4 (booth #31093)....NeoGenomics will also feature COMPASS, a suite of single-order sample-to-diagnosis services for hematological malignancies."
Clinical
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InVisionFirst®-Lung • Neo Comprehensive™ - Heme Cancers
almost2years
Real-world clinical utility of next-generation sequencing ctDNA for patients with advanced lung squamous cell carcinoma (ELCC 2024)
"Conclusions NGS-ctDNA provided clinically informative results for 26% of pts with advanced lung SCC, including 6% for whom targeted therapies are available in routine practice or clinical trials (4% ESMO ESCAT tier I and 2% ESMO ESCAT tier IIB). These results suggest that molecular profiling, including plasma NGS testing, should be considered in this population."
Clinical • Real-world evidence • Circulating tumor DNA
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EGFR (Epidermal growth factor receptor) • KRAS (KRAS proto-oncogene GTPase) • ALK (Anaplastic lymphoma kinase) • TP53 (Tumor protein P53) • PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha) • NRAS (Neuroblastoma RAS viral oncogene homolog) • PTEN (Phosphatase and tensin homolog) • IDH1 (Isocitrate dehydrogenase (NADP(+)) 1) • FGFR1 (Fibroblast growth factor receptor 1) • HRAS (Harvey rat sarcoma viral oncogene homolog) • CDKN2A (Cyclin Dependent Kinase Inhibitor 2A)
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InVisionFirst®-Lung
over2years
Trial completion • IO biomarker • Liquid biopsy • Metastases • Biopsy
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EGFR (Epidermal growth factor receptor) • PD-L1 (Programmed death ligand 1) • BRAF (B-raf proto-oncogene) • ALK (Anaplastic lymphoma kinase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS)
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PD-L1 expression • BRAF V600E • EGFR mutation • BRAF V600 • ALK rearrangement
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InVisionFirst®-Lung
over2years
Plasma-First to Accelerate Time to Treatment and Improve Target Detection in Advanced Lung Cancer: A Prospective Study (IASLC-WCLC 2023)
Liquid biopsy in the initial diagnostic workup of patients with suspected advanced NSCLC accelerates time to treatment and yields more actionable alterations. A plasma-first approach increases access to precision medicine with the potential for improved patient outcomes.
Clinical • Metastases
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InVisionFirst®-Lung
over2years
Characterization of the immune and genomic profile of a large cohort of advanced KRAS-driven non-small cell lung cancer (EACR 2023)
KRAS is a complex genetic mutation associated with heterogeneity in PD-L1 expression and co-alterations, which could serve as biomarkers for differential outcomes. STK11 co-mutation appears to be a poor prognostic biomarker in this context.
PD(L)-1 Biomarker • IO biomarker • Metastases
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KRAS (KRAS proto-oncogene GTPase) • TP53 (Tumor protein P53) • STK11 (Serine/threonine kinase 11)
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PD-L1 expression • KRAS mutation • KRAS G12C • KRAS G12V • STK11 mutation • PD-L1 negative • KRAS G12 • KRAS G13 • KRAS A146 • KRAS Q61
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PD-L1 IHC 22C3 pharmDx • Guardant360® CDx • InVisionFirst®-Lung
over2years
Integrating multiple biomarkers for early lung cancer detection in people undergoing CT screening: The iDx-Lung Study – initial correlates of demographics with analytical results (BTOG 2023)
The iDx-lung study will evaluate biomarkers and build a prediction model for the early detection of lung cancer to improve current LDCT screening protocols. The team of academic and industrial partners have successfully completed the set-up phase of this large-scale translational study. Recruitment, sample collection and analysis is underway.
InVisionFirst®-Lung • EarlyCDT®-Lung
over2years
LIBELULE: A randomized phase III study to evaluate the clinical relevance of early liquid biopsy (LB) in patients with suspicious metastatic lung cancer. (ASCO 2023)
Early LB significantly reduces the time to contributive molecular analysis and the time to initiation of appropriate 1st line therapy in pts eligible for systemic treatment, especially for pts with actionable alterations indicating targeted 1st line therapy. Clinical trial information: NCT03721120.
P3 data • Clinical • Liquid biopsy • Metastases • 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) • MET (MET proto-oncogene, receptor tyrosine kinase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS) • STK11 (Serine/threonine kinase 11) • NTRK (Neurotrophic receptor tyrosine kinase)
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BRAF V600E • EGFR mutation • ALK rearrangement • MET exon 14 mutation • ROS1 rearrangement • RET rearrangement
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InVisionFirst®-Lung
over2years
Clinical and genomic correlates of liquid biopsy (LB) derived variant allele frequency (VAF) in advanced NSCLC patients (AACR 2023)
In patients with aNSCLC, mVAF depends on disease burden, on the molecular characteristics of the disease and on the presence and extent of liver disease. LDH levels above ULN predict the presence of ctDNA and percentage of mVAF.
Clinical • Liquid biopsy • Metastases • Biopsy
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TP53 (Tumor protein P53) • RB1 (RB Transcriptional Corepressor 1)
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TP53 mutation • RB1 mutation
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FoundationOne® Liquid CDx • InVisionFirst®-Lung
over3years
LIBELULE: Evaluation of the Feasibility and Clinical Relevance of Liquid Biopsy in Patients With Suspicious Metastatic Lung Cancer (clinicaltrials.gov)
P3; Recruiting --> Active, not recruiting | Trial completion date: Oct 2022 --> Aug 2023 | Trial primary completion date: Oct 2022 --> Aug 2023
Trial completion date • Trial primary completion date • Enrollment closed • IO biomarker • Liquid biopsy
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EGFR (Epidermal growth factor receptor) • PD-L1 (Programmed death ligand 1) • BRAF (B-raf proto-oncogene) • ALK (Anaplastic lymphoma kinase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS)
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PD-L1 expression • BRAF V600E • EGFR mutation • BRAF V600 • ALK rearrangement
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InVisionFirst®-Lung
over3years
Resistance Mechanism to BRAF inhibition Identified by Single Circulating Tumor Cell molecular profiling in BRAF-mutant Non-Small-Cell Lung Cancer (EACR 2022)
In BRAF V600E -mutant NSCLC, combination therapy with dabrafenib and trametinib demonstrated robust activity, but its resistance mechanisms are poorly known. Conclusion Single CTC profiling reveals for the first-time a wide spectrum of off-target alterations in multiple oncogenic pathways from patients with BRAF -mutant NSCLC. Single CTC sequencing analysis may provide important complementary information to bulk tumor samples to assess heterogeneous resistance mechanisms and to guide precision medicine in BRAF V600E NSCLC.
Circulating tumor cells
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BRAF (B-raf proto-oncogene) • PTPRC (Protein Tyrosine Phosphatase Receptor Type C)
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TP53 mutation • BRAF V600E • BRAF mutation • BRAF V600
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InVisionFirst®-Lung
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Mekinist (trametinib) • Tafinlar (dabrafenib)