TEST:

PGDx elio™ tissue complete assay

"Labcorp...announced today PGDx elio™ tissue completeopens in a new tab has been CE-marked under the European Union's (EU) new In Vitro Diagnostic Regulation (IVDR). It is now the first and only test of its kind in the EU CE-marked for comprehensive solid tumor profiling. This marks a significant milestone in expanding access to personalized treatment options for the approximately 2.7 millionopens in a new tab people diagnosed with cancer every year in the EU."

The AVENIO CGP Assay demonstrated high agreement with 2 established CGP tests, F1CDx and PGDx, in variant reporting, and closely aligned with F1CDx in HRDsig analysis across various tissue types. These results highlight the assay's reliability and demonstrate its utility in translational research.

NGS, with its capacity for comprehensive genomic analysis, excels in detecting diverse genetic alterations, offering superior resolution compared to CMA. This study supports the use of the PGDx elio tissue complete panel as a compelling alternative to CMA, showcasing its accuracy in assessing the HRD phenotype. The observed high concordance rate further enhances its value in the clinical diagnostic setting.

The AVENIO CGP assay is an end-to-end platform for tumor genomic profiling, with proven high analytical sensitivity and specificity. Its superb performance makes it well suited for translational research, providing deep genomic analyses to accelerate cancer research.

Here we describe an interesting case of donor-derived gynecologic origin tumor found in a liver transplant recipient. TUO classification by the Northwestern DNA methylation assay was critical in the following work-up to confirm site of origin of this tumor. This case demonstrates the robustness of the TUO classifier and its utility in identifying the tumor type in challenging cases, which is essential for appropriate treatment and clinical management.

AVENIO CGP Assay delivers high reliability with a 93.8% initial pass rate and 99.3% after retest. Its automated, integrated approach reduces hands-on and turnaround time, and ensures precision with APA and ANA more than 99%, making it an efficient solution for genomic profiling in various settings.

"Labcorp...announced new strategic service offerings within its precision oncology portfolio. This expansion will extend availability of the service through owned laboratories in Geneva and Shanghai to support research and investigational use in global clinical trials, streamlining access for patients to oncology clinical trials, broadening the patient population, and helping improve logistical efficiencies through Labcorp's global network."

"TMB was also assessed by the assay and correlated to the presence of NSCLC driver alterations and was found to be significantly lower in cases with NGS-confirmed canonical driver mutations compared with those without (p=0.0019). Overall, this study validates NGS as an accurate approach for detecting structural variants while also highlighting the need for further optimization to enable harmonization across methodologies for amplifications."

Utilizing the newly developed automated workflow on the Biomek NGeniuS produced accurate and reproducible results and reduced user hands-on time and touchpoints. Variant detection across all variant classes was also highly concordant between the manual and automated workflows. Taken together, these data demonstrate the Biomek NGeniuS system can be successfully implemented to perform laboratory automation of PGDx ETC, maintaining analytical performance with reduced user intervention.

Precision medicine relies on the ability to accurately identify cancer mutations through comprehensive diagnostic approaches including tumor genomic profiling. NGS not only facilitates this requisite but can also be applied to confirm cancer diagnoses or case re-evaluations where genomic findings are inconsistent with initial pathological review. This case series expands the value of CGP beyond biomarker detection for therapy selection, and highlights the justification of its use in diagnosis confirmation and tumor characterization.

CHIP and CCUS play important roles as precursors to hematopoietic malignancies. Consequently, we characterized the population with solid tumor malignancies for mutations suspicious for CHIP/CCUS. Although <2% of our cohort demonstrated variants at time of diagnosis/recurrence, these may be significant in determining treatment options in the future.

Conclusions This exploratory analysis of the MOUNTAINEER trial found generally consistent clinical efficacy of TUC + Tras to the primary analysis across subsets of pts w/ HER2+ RAS-WT mCRC and other clinically relevant genomic alterations. Table: 551O cORR DOR n % 95% CI n Months 95% CI Mutations Tissue NGS 45 46.7 31.7 – 62.1 21 15.3 8.9 – 25.5 ERBB2 6 66.7 22.3 – 95.7 - APC 36 44.4 27.9 – 61.9 16 16.6 6.1 – NE TP53 40 45.0 29.3 – 61.5 18 16.6 8.9 – NE ctDNA NGS 66 39.4 27.6 – 52.2 26 12.4 8.3 – 20.5 PIK3CA 7 28.6 3.7 – 71.0 - ERBB2 15 46.7 21.3 – 73.4 7 11.4 6.1 – NE APC 37 45.9 29.5 – 63.1 17 15.3 6.2 – NE Amplifications Tissue NGS 45 46.7 31.7 – 62.1 21 15.3 8.9 – 25.5 ERBB2 44 47.7 32.5 – 63.3 21 15.3 8.9 – 25.5 BRCA2 5 80.0 28.4 – 99.5 - ctDNA NGS 66 39.4 27.6 – 52.2 26 12.4 8.3 – 20.5 BRAF 7 14.3 0.4 – 57.9 - CCND1 7 14.3 0.4 – 57.9 - CDK6 10 30.0 6.7 – 65.2 - EGFR 19 36.8 16.3 – 61.6 7 12.5 4.2 – NE ERBB2 57 40.4 27.6 – 54.2 23 12.4 6.2 – 38.3 PIK3CA 5 40.0 5.3 – 85.3 - *cORR and DOR were not calculated for sample sizes <5.