TEST:

Labcorp® Plasma Complete™

METamp occurred more frequently in responders; but Teliso-V activity wasn’t restricted to these pts: most responders weren’t METamplified. Specific genomic alts beyond MET may influence clinical response. The current analysis demonstrated numeric differences between pts with identified drivers who did or didn’t respond to Teliso-V.

"Labcorp researchers performed comprehensive genomic and immune profiling on 143 formalin-fixed paraffin-embedded breast cancer samples to investigate the interaction between VEGF and immune gene expression. In triple-negative breast cancer (TNBC) samples, VEGF was co-expressed with immune checkpoint genes such as PD-1 and PD-L1...Labcorp researchers performed a targeted RNA-sequence-based assay on 143 breast cancer patient samples, demonstrating that concurrent loss of HLA class I with increased HLA class II expression was associated with co-expression of biomarkers indicative of immune escape but not survival outcomes...Researchers analyzed genomic and gene expression data from over 2,000 colorectal cancer samples to generate and test a model for predicting MSI status, which was confirmed using MSI status from The Cancer Genome Atlas (TCGA) studies of colorectal and endometrial carcinoma."

TERT, TP53, and CTNNB1 MUT had little effect on tumor response in either treatment arm; TP53 MUT appeared to be a factor for poor OS prognosis in both arms. Further analysis is needed due to the differences in baseline characteristics between ctDNA and ITT pts, and the difference in sample size between arms.

The analytical validation of the Labcorp Plasma Complete test demonstrates that the liquid biopsy approach is highly sensitive, specific, accurate, reproducible, and robust for comprehensive genomic profiling to complement tissue-based testing and inform clinical decision making.

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.

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.

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.

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.

“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.”

"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."