Analytical Validation of NavDx, a cfDNA-Based Fragmentomic Profiling Assay for HPV-Driven Cancers

• DOI: 10.3390/diagnostics13040725
• Publication Date: 2023-02-15T08:37:24Z
• Authors: Alicia Gunning; Sunil Kumar; Cassin Kimmel Wil...; Barry M. Berger; Stephen P. Naber; Piyush B. Gupta; Catherine Del Vec...; Charlotte Kuperwa...
• Keywords: Circulating tumor DNA

The NavDx® blood test analyzes tumor tissue modified viral (TTMV)-HPV DNA to provide a reliable means of detecting and monitoring HPV-driven cancers. has been clinically validated in large number independent studies integrated into clinical practice by over 1000 healthcare providers at 400 medical sites the US. This Clinical Laboratory Improvement Amendments (CLIA), high complexity laboratory developed test, also accredited College American Pathologists (CAP) New York State Department Health. Here, we report detailed analytical validation NavDx assay, including sample stability, specificity as measured limits blank (LOBs), sensitivity illustrated via detection quantitation (LODs LOQs). LOBs were 0-0.32 copies/μL, LODs 0-1.10 LOQs <1.20-4.11 demonstrating data provided NavDx. In-depth evaluations accuracy intra- inter-assay precision shown be well within acceptable ranges. Regression analysis revealed degree correlation between expected effective concentrations, excellent linearity (R2 = 1) across broad range analyte concentrations. These results demonstrate that accurately reproducibly detects circulating TTMV-HPV DNA, which aid diagnosis surveillance