TEST:

TruSight Tumor 170 Assay

Seven tremelimumab-related serious adverse events (grade 2-3) occurred in 5 patients. While the primary PFS6 endpoint was not met, there were two durable objective responses in rare cancers and a favourable change in disease trajectory for an additional five patients based on TTP ratio 1.3.

Its sensitivity for low-frequency variants enables real-time treatment adaptation, supporting precision oncology. Its comprehensive design is particularly valuable for challenging diagnoses and clonal evolution monitoring.

Within this range, the integration of TMB into the MSI classification workflow significantly improves diagnostic accuracy. For samples that remain inconclusive, orthogonal confirmation using MSI-PCR is advised to ensure accurate MSI classification.

This study demonstrates the feasibility of implementing cfDNA tumor profiling from blood in our laboratory. This assay provides sensitive detection of genomic variants in a cfDNA sample . Initially, the reporting will be performed for 64 genes covering only SNVs and insertions/deletions.

In this study, we applied the iSCORED pipeline for ultrafast, genome-wide CNV information of renal tumors with results showing complete concordance with established CNV analysis methods. This method could facilitate pathological diagnosis and potentially inform targeted treatment in less than 2 hours. Future directions include expanding analyzed tumor types and integrating methylation classification into the pipeline.

In second-line treatment, no difference between an Irinotecan-based regimen and re-exposure to platinum-based agents (12.36 vs 10.13 months; HR 0.92; P=0.85) could be observed (HR 1.45; P=0.35). HRRm BTC patients showed a potential advantage in OS following platinum-based first-line chemotherapy, presumably attributed to enhanced opportunities for targetable co-alterations. Further investigation is needed to delineate HRD in the context of personalizing systemic therapies of BTC.

Response duration was 12.0 and 9.3 months for patients identified by the ODxT Test and CTAs, respectively, in DESTINY-Lung01. The ODxT Test detected HER2 mutations in NSCLC with high analytical and clinical accuracy and identified HER2m populations with response rates similar to populations identified by CTAs, supporting clinical utility of the ODxT Test to inform treatment decisions for HER2m NSCLC.

P2; Active, not recruiting --> Completed

A trend for a clinical benefit of second-line therapy with re-exposure to platinum-based agents as compared to irinotecan-based regimens was observed (HR= 0.79, 95%CI 0.34-1.8, P= 0.56)... Platinum-based chemotherapy associates with more favorable outcomes in HRRm BTC patients. Further investigation is needed to delineate HRD in the context of personalizing systemic therapies of BTC.

The 6 AV studies met the necessary product requirements and acceptance criteria to detect clinical samples with ERBB2 mutations. Additionally, the CV study clinical accuracy and clinical efficacy results demonstrated the safety and effectiveness of the use of the ODxTT in FFPE samples as an aid to identify NSCLC patients eligible for treatment with the Daiichi Sankyo lung cancer therapeutic T-DXd.

Moreover, simultaneously available transcript quantification and variant calling provide the ability to implement several disease classifiers. This work lays the foundation for integration with our clinically available tumor exome sequencing assay to allow joint exome transcriptome analysis in a single informatics platform.

Mutations in ESR1 and in PI3K pathway genes at T0 were associated with worse prognosis in palbociclib-treated patients. We describe the emergence of newly acquired mutations in palbociclib-treated patients, which might potentially affect subsequent treatment.