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...
Saved in:
| Main Authors: | , , , , , , , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
MDPI AG
2025-03-01
|
| Series: | Diagnostics |
| Subjects: | |
| Online Access: | https://www.mdpi.com/2075-4418/15/7/825 |
| Tags: |
Add Tag
No Tags, Be the first to tag this record!
|
| _version_ | 1849739489031749632 |
|---|---|
| author | Joshua Hutcheson David Conway Sunil Kumar Chloe Wiseman Syandan Chakraborty Evgeny Skrypkin Michael Horan Alicia Gunning Cassin Kimmel Williams Charlotte Kuperwasser Stephen P. Naber Piyush B. Gupta |
| author_facet | Joshua Hutcheson David Conway Sunil Kumar Chloe Wiseman Syandan Chakraborty Evgeny Skrypkin Michael Horan Alicia Gunning Cassin Kimmel Williams Charlotte Kuperwasser Stephen P. Naber Piyush B. Gupta |
| author_sort | Joshua Hutcheson |
| collection | DOAJ |
| description | <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. |
| format | Article |
| id | doaj-art-a08a074de3ab4a13a737f6458e112930 |
| institution | DOAJ |
| issn | 2075-4418 |
| language | English |
| publishDate | 2025-03-01 |
| publisher | MDPI AG |
| record_format | Article |
| series | Diagnostics |
| spelling | doaj-art-a08a074de3ab4a13a737f6458e1129302025-08-20T03:06:16ZengMDPI AGDiagnostics2075-44182025-03-0115782510.3390/diagnostics15070825Analytical Validation of NavDx+Gyn, a cfDNA-Based Fragmentomic Profiling Assay for HPV-Driven Gynecologic CancersJoshua Hutcheson0David Conway1Sunil Kumar2Chloe Wiseman3Syandan Chakraborty4Evgeny Skrypkin5Michael Horan6Alicia Gunning7Cassin Kimmel Williams8Charlotte Kuperwasser9Stephen P. Naber10Piyush B. Gupta11Naveris, Inc., Waltham, MA 02451, USANaveris, Inc., Waltham, MA 02451, USANaveris, Inc., Waltham, MA 02451, USANaveris, Inc., Waltham, MA 02451, USANaveris, Inc., Waltham, MA 02451, USANaveris, Inc., Waltham, MA 02451, USANaveris, Inc., Waltham, MA 02451, USANaveris, Inc., Waltham, MA 02451, USANaveris, Inc., Waltham, MA 02451, USANaveris, Inc., Waltham, MA 02451, USANaveris, Inc., Waltham, MA 02451, USANaveris, Inc., Waltham, MA 02451, USA<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.https://www.mdpi.com/2075-4418/15/7/825NavDx+Gyncervical cancervaginal cancervulvar cancerHPVpapillomavirus |
| spellingShingle | Joshua Hutcheson David Conway Sunil Kumar Chloe Wiseman Syandan Chakraborty Evgeny Skrypkin Michael Horan Alicia Gunning Cassin Kimmel Williams Charlotte Kuperwasser Stephen P. Naber Piyush B. Gupta Analytical Validation of NavDx+Gyn, a cfDNA-Based Fragmentomic Profiling Assay for HPV-Driven Gynecologic Cancers Diagnostics NavDx+Gyn cervical cancer vaginal cancer vulvar cancer HPV papillomavirus |
| title | Analytical Validation of NavDx+Gyn, a cfDNA-Based Fragmentomic Profiling Assay for HPV-Driven Gynecologic Cancers |
| title_full | Analytical Validation of NavDx+Gyn, a cfDNA-Based Fragmentomic Profiling Assay for HPV-Driven Gynecologic Cancers |
| title_fullStr | Analytical Validation of NavDx+Gyn, a cfDNA-Based Fragmentomic Profiling Assay for HPV-Driven Gynecologic Cancers |
| title_full_unstemmed | Analytical Validation of NavDx+Gyn, a cfDNA-Based Fragmentomic Profiling Assay for HPV-Driven Gynecologic Cancers |
| title_short | Analytical Validation of NavDx+Gyn, a cfDNA-Based Fragmentomic Profiling Assay for HPV-Driven Gynecologic Cancers |
| title_sort | analytical validation of navdx gyn a cfdna based fragmentomic profiling assay for hpv driven gynecologic cancers |
| topic | NavDx+Gyn cervical cancer vaginal cancer vulvar cancer HPV papillomavirus |
| url | https://www.mdpi.com/2075-4418/15/7/825 |
| work_keys_str_mv | AT joshuahutcheson analyticalvalidationofnavdxgynacfdnabasedfragmentomicprofilingassayforhpvdrivengynecologiccancers AT davidconway analyticalvalidationofnavdxgynacfdnabasedfragmentomicprofilingassayforhpvdrivengynecologiccancers AT sunilkumar analyticalvalidationofnavdxgynacfdnabasedfragmentomicprofilingassayforhpvdrivengynecologiccancers AT chloewiseman analyticalvalidationofnavdxgynacfdnabasedfragmentomicprofilingassayforhpvdrivengynecologiccancers AT syandanchakraborty analyticalvalidationofnavdxgynacfdnabasedfragmentomicprofilingassayforhpvdrivengynecologiccancers AT evgenyskrypkin analyticalvalidationofnavdxgynacfdnabasedfragmentomicprofilingassayforhpvdrivengynecologiccancers AT michaelhoran analyticalvalidationofnavdxgynacfdnabasedfragmentomicprofilingassayforhpvdrivengynecologiccancers AT aliciagunning analyticalvalidationofnavdxgynacfdnabasedfragmentomicprofilingassayforhpvdrivengynecologiccancers AT cassinkimmelwilliams analyticalvalidationofnavdxgynacfdnabasedfragmentomicprofilingassayforhpvdrivengynecologiccancers AT charlottekuperwasser analyticalvalidationofnavdxgynacfdnabasedfragmentomicprofilingassayforhpvdrivengynecologiccancers AT stephenpnaber analyticalvalidationofnavdxgynacfdnabasedfragmentomicprofilingassayforhpvdrivengynecologiccancers AT piyushbgupta analyticalvalidationofnavdxgynacfdnabasedfragmentomicprofilingassayforhpvdrivengynecologiccancers |