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TEST:
PGDx elio™ plasma complete assay

Company:
LabCorp
Type:
Laboratory Developed Test
Related tests:
Evidence

News

2ms
Enhanced detection of ctDNA molecular response for immunotherapy treated non-small cell lung cancer through analyses of cell-free and matched white blood cell DNA (AACR 2024)
This real-world study of ICI treated, advanced NSCLC highlights the opportunity afforded through integrated analyses of ctDNA and matched WBCs to accurately determine mR and the associations with radiographic response and OS.
Tumor mutational burden • PD(L)-1 Biomarker • IO biomarker • Circulating tumor DNA
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PD-L1 (Programmed death ligand 1) • TMB (Tumor Mutational Burden)
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PGDx elio™ plasma complete assay
1year
Impact of genomic alterations measured in circulating tumor DNA (ctDNA) on clinical response to telisotuzumab vedotin treatment in patients with non-small cell lung cancer (NSCLC). (ASCO 2023)
MET amp occurred more frequently in responders; however, Teliso-V activity was not restricted to these pts, as most responders were not MET amplified. Specific genomic alterations beyond MET may influence clinical response. The current analysis demonstrated numeric differences between pts with identified drivers who did or did not respond to Teliso-V.
Clinical • Circulating tumor DNA
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EGFR (Epidermal growth factor receptor) • KRAS (KRAS proto-oncogene GTPase) • MET (MET proto-oncogene, receptor tyrosine kinase)
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KRAS G12C • MET amplification • EGFR wild-type • MET overexpression • MET mutation • KRAS G12
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PGDx elio™ plasma complete assay
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telisotuzumab vedotin (ABBV-399)
1year
Enhanced detection and classification of cell-free DNA alterations through matched normal analyses with PGDx elioTM plasma complete (AACR 2023)
Additional sources of discordance for somatic and germline alterations were primarily attributed to patients with high levels of ctDNA where differentiation of these variant sources can be challenging through solely computational-based techniques. Taken together, these data demonstrate that through the integrated analysis of cell-free DNA and matched leukocyte DNA, classification of the source of cfDNA-derived alterations can be achieved, which may improve the accuracy of non-invasive tumor profiling, molecular response assessment, and clonal evolution analyses.
Tumor mutational burden
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TMB (Tumor Mutational Burden) • MSI (Microsatellite instability)
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PGDx elio™ plasma complete assay
2years
Comprehensive liquid biopsy profiling enabled by PGDx elio plasmacomplete to facilitate precision oncology through decentralized access to testing (AACR 2022)
The PGDx elio plasma complete assay can be processed manually or through automated liquid handling systems with high concordance, with an overall success rate of 97.8%. Taken together, these data demonstrate that the PGDx elio plasma complete assay is a sensitive, specific, accurate, reproducible, and robust approach to enable CGP to guide both translational biomarker discovery and CGP-informed precision oncology strategies.
Tumor mutational burden • BRCA Biomarker • Liquid 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) • PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha) • TMB (Tumor Mutational Burden) • NRAS (Neuroblastoma RAS viral oncogene homolog) • BRCA1 (Breast cancer 1, early onset) • BRCA2 (Breast cancer 2, early onset) • MSI (Microsatellite instability) • RET (Ret Proto-Oncogene) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS) • NTRK1 (Neurotrophic tyrosine kinase, receptor, type 1) • NTRK3 (Neurotrophic tyrosine kinase, receptor, type 3) • FGFR1 (Fibroblast growth factor receptor 1) • NTRK2 (Neurotrophic tyrosine kinase, receptor, type 2)
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PGDx elio™ plasma complete assay
over2years
Personal Genome Diagnostics and Cleveland Clinic Collaborate to Expand Utility of Liquid Biopsy Applications in Oncology Clinical Research (Personal Genome Diagnostics Press Release)
“Personal Genome Diagnostics…announced a collaboration with the Center for Immunotherapy and Precision Immuno-Oncology (CITI) and the Cleveland Clinic Lerner Research Institute, Cleveland, Ohio. Both parties will collaborate to enhance capabilities within elioTM plasma complete reporting, as well as collaborate on the development of proprietary methods for complex biomarker detection and assay iterations to meet emerging liquid biopsy applications in solid tumors. This strategic collaboration combines Cleveland Clinic’s world-class research and commitment to innovation with the comprehensive PGDx portfolio and actionable genomic information. Both organizations are driven to elevate the standard of care for patients and increase utilization of precision diagnostics within the cancer care continuum.”
Licensing / partnership
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PGDx elio™ plasma complete assay
almost3years
Personal Genome Diagnostics launches elio™ plasma complete, a kit enabling decentralized, comprehensive liquid biopsy analysis for oncology research applications (Personal Genome Diagnostics Press Release)
"Personal Genome Diagnostics Inc. (PGDx)...today announced the launch of elio™ (empowering local insight for oncology) plasma complete, a NGS kit solution for comprehensive blood-based genomic analysis. The elio™ plasma complete kit is intended to support research in areas like biomarker discovery, therapy selection, and monitoring, and is ideal for investigating genetic mutations and genomic signatures in multiple cancer types."
Launch
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PGDx elio™ plasma complete assay