Technical Specifications
Technical Specifications
DELFI-TF Intended Use:
DELFI-TF is a research service that has been developed to provide early evidence of treatment efficacy in early (phase I-II) oncology drug development trials
DELFI-TF has been applied by multiple pharmaceutical and biotechnology companies as a tool for early clinical decision-making in phase I-II development trials for diverse New Molecular Entities (NME).
DELFI-TF Assay Performance Characteristics:
Below is a summary of the performance metrics tested for the DELFI-TF assay*:
Performance Metric
DELFI-TF Performance
| Sample Requirement | 800 uL plasma or 1 ng cfDNA |
|---|---|
| Success Rate** | 99% |
| Limit of Blank*** | 0.3% |
| Reproducibility: Coefficient of VariationIn samples between LOB and 2x LOD, median(25%ile.75%ile) | 13.6%(6.4%,21.0%) |
| Correlation with MAF(validation cohort) | 0.94% |
| Concordance with RECIST(mNSCLC) | 77% |
*The DELFI-TF Assay and related services are for Research Purposes Only and are not intended for diagnostic procedures or applications. **The success rate for this study is defined as the percentage of plasma samples able to be processed through the DELFI assay pipeline (WGS using 1ng of cfDNA). ***The limit of blank was previously defined as the maximum of 95th percentile of DELFI-TF among multiple non-cancer cohorts.