# 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.