Search Results (2)

Background/Objectives: The NavDx+Gyn blood test detects and quantifies fourteen HPV types in various sample types to provide a reliable means of detecting and monitoring HPV-driven gynecologic cancers. NavDx+Gyn is an extension of the NavDx assay, which identifies five high-risk HPV types. NavDx has been clinically validated in multiple independent studies for the surveillance of HPV-driven oropharyngeal cancer and has been integrated into clinical practice by over 1300 healthcare providers at over 500 medical sites in the US. The NavDx+Gyn assay incorporates an analysis of nine additional high-risk HPV types. Here, we report a detailed analytical validation of the NavDx+Gyn assay for use in cervical, vaginal, and vulvar cancer patients to detect fourteen high-risk HPV types related to HPV-driven gynecologic cancers. Methods: Parameters include specificity as measured by limits of blank (LoBs) and sensitivity illustrated via limits of detection and quantitation (LoDs and LoQs). Results: The LoBs were between 0 and 0.0926 copies/μL, LoDs were 0.1009 to 0.3147 copies/μL, and LoQs were 0.1009 to 0.3147 copies/μL, demonstrating the high analytic sensitivity and specificity provided by NavDx+Gyn. In-depth evaluations, including accuracy and intra- and inter-assay precision studies, were shown to be within acceptable ranges. Regression analysis revealed a high degree of correlation between expected and effective concentrations, demonstrating excellent linearity (R² > 0.99) across a broad range of analyte concentrations. Conclusions: These results demonstrate that NavDx+Gyn accurately and reproducibly detects fourteen types of high-risk HPV, which aids in the diagnosis and surveillance of the vast majority of HPV-driven gynecologic cancers. Full article

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 (R² = 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. Full article