TEST:

PGDx elio™ plasma resolve assay

Cohorts A, B, and 0 will enroll patients receiving alectinib as the first ALK-TKI, receiving alectinib as the first ALK-TKI and subsequently cytotoxic agents and/or lorlatinib after alectinib, and without a history of ALK-TKI, respectively. The results will provide crucial information for establishing treatment strategies, discovering novel biomarkers, and developing new therapeutic agents. UMIN000042439.

A cutoff of 0.25% variant allele frequency (VAF) was set up for diagnostic reporting. An inter-laboratory study of concordance with an orthologous test resulted in a positive percent agreement (PPA) of 91.7%.

High frequency of detecting actionable variants, high plasma-tissue concordance, and shorter time to reporting support the clinical feasibility and utility of ctDNA-based liquid biopsy as a firstapproach test when sufficient tumor tissue is unavailable. At the same time, variable frequency of actionable variants detected across different tumor types suggests that a tumor-specific approach should be considered.

High frequency of detecting actionable variants, high plasma-tissue concordance, and shorter time to reporting support the clinical feasibility and utility of ctDNA-based liquid biopsy as a firstapproach test when sufficient tumor tissue is unavailable. At the same time, variable frequency of actionable variants detected across different tumor types suggests that a tumor-specific approach should be considered.

This 33-gene ctDNA NGS assay shows high reproducibility, accuracy, and sensitivity, which enable the assay to be applied clinically in cancer mutation profiling to aid clinical decision making for oncology patients. In addition, our clinical experience strongly supports clinical feasibility and utility of ctDNA panels for advanced cancer patients.

This 33-gene ctDNA NGS assay shows high reproducibility, accuracy, and sensitivity, which enable the assay to be applied clinically in cancer mutation profiling to aid clinical decision making for oncology patients.

These cases show that combined tissue and ctDNA profiling at the time of initial diagnosis can reveal tumor heterogeneity or distinct metastases not observed in a selected tissue sample, and that profiling during and after therapy may provide early detection of recurrence, appearance of resistance mutations, or monitoring of measurable residual disease.

Once sequencing data is obtained, multivariate Cox regression analysis will be used to assess the association between post-surgery ctDNA detection and progression-free and overall survival. Ultimately, the results of this study will be used to design an ethically acceptable and cost-effective ctDNA-guided interventional trial in stage III colon cancer patients, in order to improve the risk stratification and reduce futile ACT and its associated side-effects.

"Personal Genome Diagnostics Inc...reported the publication of a research paper in The Oncologist, titled 'Validation of a ctDNA-based next-generation sequencing assay in a cohort of solid tumor patients: a proposed solution for decentralized plasma testing,' which assessed the performance of the company’s elio™ plasma resolve assay. This is the first study validating that a decentralized plasma-based next-generation sequencing (NGS) test can detect microsatellite instability (MSI) status along with the comprehensive landscape of sequence and structural alterations encountered across solid tumors."

Although there are reference labs perform single-site comprehensive liquid biopsy testing, the targeted assay we validated can be established locally in any lab with capacity to offer clinical molecular pathology assays. To our knowledge, this is the first report validating evaluating an on-site plasma-based NGS test detects the MSI status along with common sequence alterations encountered in solid tumors.

"Personal Genome Diagnostics Inc. (PGDx)…today announced a strategic collaboration with Fox Chase Cancer Center in Philadelphia for the PGDx elio™ plasma resolve liquid biopsy panel. The strategic collaboration combines the world-class Fox Chase research and clinical expertise in the community healthcare setting with PGDx leadership in the development of comprehensive genomic products that can be distributed and used in laboratories worldwide, wherever patients seek treatment for their cancer. Both organizations are driven by the overall goal of bringing the highest standards of care to patients in communities across the globe."