Analytical Validation of NavDx, a cfDNA-Based Fragmentomic Profiling Assay for HPV-Driven Cancers.
Alicia GunningSunil KumarCassin Kimmel WilliamsBarry M BergerStephen P NaberPiyush B GuptaCatherine Del Vecchio FitzCharlotte KuperwasserPublished in: Diagnostics (Basel, Switzerland) (2023)
The NavDx ® blood test analyzes tumor tissue modified viral (TTMV)-HPV DNA to provide a reliable means of detecting and monitoring HPV-driven cancers. The test has been clinically validated in a large number of independent studies and has been integrated into clinical practice by over 1000 healthcare providers at over 400 medical sites in the US. This Clinical Laboratory Improvement Amendments (CLIA), high complexity laboratory developed test, has also been accredited by the College of American Pathologists (CAP) and the New York State Department of Health. Here, we report a detailed analytical validation of the NavDx assay, including sample stability, specificity as measured by limits of blank (LOBs), and sensitivity illustrated via limits of detection and quantitation (LODs and LOQs). LOBs were 0-0.32 copies/μL, LODs were 0-1.10 copies/μL, and LOQs were <1.20-4.11 copies/μL, demonstrating the high sensitivity and specificity of data provided by NavDx. In-depth evaluations including accuracy and intra- and inter-assay precision studies were shown to be well within acceptable ranges. Regression analysis revealed a high degree of correlation between expected and effective concentrations, demonstrating excellent linearity (R 2 = 1) across a broad range of analyte concentrations. These results demonstrate that NavDx accurately and reproducibly detects circulating TTMV-HPV DNA, which has been shown to aid in the diagnosis and surveillance of HPV-driven cancers.
Keyphrases
- healthcare
- high grade
- high throughput
- clinical practice
- public health
- cervical cancer screening
- liquid chromatography
- circulating tumor
- mass spectrometry
- sars cov
- cell free
- single molecule
- single cell
- mental health
- ms ms
- artificial intelligence
- optical coherence tomography
- young adults
- high performance liquid chromatography
- risk assessment
- nucleic acid
- label free
- data analysis
- tandem mass spectrometry
- tertiary care