Analytical Validation of NavDx+Gyn, a cfDNA-Based Fragmentomic Profiling Assay for HPV-Driven Gynecologic Cancers
<b>Background/Objectives</b>: 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 H...
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| Main Authors: | , , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
| Published: |
MDPI AG
2025-03-01
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| Series: | Diagnostics |
| Subjects: | |
| Online Access: | https://www.mdpi.com/2075-4418/15/7/825 |
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| Summary: | <b>Background/Objectives</b>: 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. <b>Methods</b>: Parameters include specificity as measured by limits of blank (LoBs) and sensitivity illustrated via limits of detection and quantitation (LoDs and LoQs). <b>Results</b>: 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 (R<sup>2</sup> > 0.99) across a broad range of analyte concentrations. <b>Conclusions</b>: 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. |
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| ISSN: | 2075-4418 |