دورية أكاديمية
Analytical Validation of NavDx, a cfDNA-Based Fragmentomic Profiling Assay for HPV-Driven Cancers
| العنوان: | Analytical Validation of NavDx, a cfDNA-Based Fragmentomic Profiling Assay for HPV-Driven Cancers |
|---|---|
| المؤلفون: | Alicia Gunning, Sunil Kumar, Cassin Kimmel Williams, Barry M. Berger, Stephen P. Naber, Piyush B. Gupta, Catherine Del Vecchio Fitz, Charlotte Kuperwasser |
| المصدر: | Diagnostics, Vol 13, Iss 4, p 725 (2023) |
| بيانات النشر: | MDPI AG, 2023. |
| سنة النشر: | 2023 |
| المجموعة: | LCC:Medicine (General) |
| مصطلحات موضوعية: | NavDx, HPV, oropharyngeal, cancer, papillomavirus, profiling assay, Medicine (General), R5-920 |
| الوصف: | 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 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. |
| نوع الوثيقة: | article |
| وصف الملف: | electronic resource |
| اللغة: | English |
| تدمد: | 2075-4418 39247783 |
| العلاقة: | https://www.mdpi.com/2075-4418/13/4/725Test; https://doaj.org/toc/2075-4418Test |
| DOI: | 10.3390/diagnostics13040725 |
| الوصول الحر: | https://doaj.org/article/4068731a865645a39247783db3a85438Test |
| رقم الانضمام: | edsdoj.4068731a865645a39247783db3a85438 |
| قاعدة البيانات: | Directory of Open Access Journals |
Full Text Finder | تدمد: | 20754418 39247783 |
|---|---|
| DOI: | 10.3390/diagnostics13040725 |