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

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 healthca...

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Autores principales: Gunning, Alicia, Kumar, Sunil, Williams, Cassin Kimmel, Berger, Barry M., Naber, Stephen P., Gupta, Piyush B., Del Vecchio Fitz, Catherine, Kuperwasser, Charlotte
Formato: Online Artículo Texto
Lenguaje:English
Publicado: MDPI 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9955790/
https://www.ncbi.nlm.nih.gov/pubmed/36832208
http://dx.doi.org/10.3390/diagnostics13040725
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author Gunning, Alicia
Kumar, Sunil
Williams, Cassin Kimmel
Berger, Barry M.
Naber, Stephen P.
Gupta, Piyush B.
Del Vecchio Fitz, Catherine
Kuperwasser, Charlotte
author_facet Gunning, Alicia
Kumar, Sunil
Williams, Cassin Kimmel
Berger, Barry M.
Naber, Stephen P.
Gupta, Piyush B.
Del Vecchio Fitz, Catherine
Kuperwasser, Charlotte
author_sort Gunning, Alicia
collection PubMed
description 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.
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spelling pubmed-99557902023-02-25 Analytical Validation of NavDx, a cfDNA-Based Fragmentomic Profiling Assay for HPV-Driven Cancers Gunning, Alicia Kumar, Sunil Williams, Cassin Kimmel Berger, Barry M. Naber, Stephen P. Gupta, Piyush B. Del Vecchio Fitz, Catherine Kuperwasser, Charlotte Diagnostics (Basel) 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 (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. MDPI 2023-02-14 /pmc/articles/PMC9955790/ /pubmed/36832208 http://dx.doi.org/10.3390/diagnostics13040725 Text en © 2023 by the authors. https://creativecommons.org/licenses/by/4.0/Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (https://creativecommons.org/licenses/by/4.0/).
spellingShingle Article
Gunning, Alicia
Kumar, Sunil
Williams, Cassin Kimmel
Berger, Barry M.
Naber, Stephen P.
Gupta, Piyush B.
Del Vecchio Fitz, Catherine
Kuperwasser, Charlotte
Analytical Validation of NavDx, a cfDNA-Based Fragmentomic Profiling Assay for HPV-Driven Cancers
title Analytical Validation of NavDx, a cfDNA-Based Fragmentomic Profiling Assay for HPV-Driven Cancers
title_full Analytical Validation of NavDx, a cfDNA-Based Fragmentomic Profiling Assay for HPV-Driven Cancers
title_fullStr Analytical Validation of NavDx, a cfDNA-Based Fragmentomic Profiling Assay for HPV-Driven Cancers
title_full_unstemmed Analytical Validation of NavDx, a cfDNA-Based Fragmentomic Profiling Assay for HPV-Driven Cancers
title_short Analytical Validation of NavDx, a cfDNA-Based Fragmentomic Profiling Assay for HPV-Driven Cancers
title_sort analytical validation of navdx, a cfdna-based fragmentomic profiling assay for hpv-driven cancers
topic Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9955790/
https://www.ncbi.nlm.nih.gov/pubmed/36832208
http://dx.doi.org/10.3390/diagnostics13040725
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