Review our FAQs to get more information about the NavDx test and other related topics
How does the NavDx blood test work?
The NavDx blood test is the first and only clinically validated circulating tumor tissue modified viral (TTMV®)-HPV DNA blood test that aids in the detection of HPV-driven cancers.4 TTMV-HPV DNA is a unique biomarker of tumors driven by human papillomavirus. The NavDx test analyzes the pattern of TTMV-HPV DNA fragments released by tumor cells into the blood to provide a TTMV Score, reflective of the normalized TTMV-HPV DNA fragments /mL of plasma.4,6 NavDx testing has demonstrated ≥97% specificity and ≥89% sensitivity to more accurately detect disease status in HPV-driven oropharyngeal squamous cell carcinoma (OPSCC).6 NavDx testing reliably distinguishes TTMV-HPV DNA from non-cancerous sources of HPV DNA, regardless of tumor HPV integration status.4 The NavDx blood test can detect and identify the most prevalent high-risk HPV genotypes, including HPV-16, HPV-18, HPV-31, HPV-33, and HPV-35.4,8
What information does the NavDx test results report provide?
NavDx testing analyzes the pattern of TTMV®-HPV DNA fragments released by tumor cells into the blood, which is used to generate a score.4,8 The NavDx test results report includes your patient's TTMV-HPV DNA status (present or absent), their TTMV-HPV DNA Score (TTMV Score), and their HPV genotype. The report features a graph that sequentially plots the patient's TTMV Score for each NavDx test performed and a results and interpretation section, where Naveris provides a brief qualitative written interpretation of the test result. The easy-to-interpret, actionable NavDx test results report helps inform clinical decisions so you can optimize HPV+ oropharyngeal and anal cancer care.
Who are the appropriate patients to receive the NavDx blood test?
Any patients with HPV-driven oropharyngeal or anal cancer are appropriate candidates for NavDx testing. The NavDx blood test is currently being used to help physicians detect and monitor HPV-positive oropharyngeal (head and neck) and anal cancer. NavDx testing is used to confirm that the tumor is HPV-positive, to assess treatment response, and to detect recurrences, including in distant metastases. The test is also being studied for use in cases of HPV-positive cervical cancer. The
clinical utility of NavDx testing has been validated in a 3-year longitudinal study and proven in real-world practice.6
What are the recommendations for using the NavDx test?
Following definitive treatment, NavDx testing can reliably monitor for HPV-driven head and neck cancer recurrence during surveillance. Serial testing of TTMV-HPV DNA with the NavDx blood test demonstrated ≥98% negative predictive value and ≥95% positive predictive value for active HPV-driven malignancy, and accurately detected biopsy-proven recurrence a median of 4 months earlier than imaging.6,7
NavDx Testing
Clinical practice guidelines and CMS coverage policy for recurrence detection include surveillance at specified intervals:
During Surveillance
≤2 years post treatment: every 3 months
3-5 years post treatment: every 6 months
6+ years post treatment: 1 time per year
Can NavDx testing distinguish between cancerous and noncancerous HPV DNA?
Yes. The NavDx blood test reliably distinguishes TTMV-HPV DNA from non-cancerous sources of HPV DNA, regardless of tumor HPV integration status.4 NavDx testing has demonstrated a ≥97% specificity and ≥89% sensitivity to identify patients with newly diagnosed and nonmetastatic HPV-driven oropharyngeal squamous cell carcinoma (OPSCC).6 The NavDx test utilizes proprietary, quantitative digital droplet PCR (ddPCR) technology to analyze fragments of circulating TTMV-HPV DNA, a unique biomarker of tumors driven by HPV.6 NavDx testing can detect and identify the most prevalent high-risk HPV genotypes, including HPV-16, HPV-18, HPV-31, HPV-33, and HPV-35.6
Is NavDx testing covered by insurance?
Medicare covers serial NavDx testing of TTMV-HPV DNA for surveillance of recurrence in patients with a history of documented HPV-driven oropharyngeal cancer, who presently have no evidence of disease, starting one day following surgery or 7 days following chemotherapy, radiation therapy and/or immunotherapy. The NavDx test is also covered by many commercial health insurance companies and is continually pursuing and gaining coverage to ensure patients have access to the test. In the event NavDx testing is not covered by your patient's insurance plan, Naveris may appeal to the insurance company on your patient's behalf. Should you have any questions about insurance coverage or billing policies, please contact our Billing team at (833) NAVERIS or email us at billing@naveris.com.
Is there financial assistance for patient costs?
Naveris is committed to ensuring that the NavDx test is accessible to patients by providing support services, as well as financial assistance to those who qualify. Our Naveris Billing team works with patients so that cost is not a barrier to testing. Depending on your patient's insurance plan, there may be an out-of-pocket portion that a patient is responsible to pay as part of a deductible or coinsurance. Our Naveris Billing team works to make the NavDx test accessible, by submitting insurance claims, helping interpret explanations of benefits (EOBs), helping with appeals on behalf of patients, and determining financial assistance eligibility. If your patient is experiencing financial hardship, they may qualify for financial assistance through the Naveris Cares™ program.
Can my patients use their HSA/FSA to pay for the NavDx blood test?
Patients should check with their HSA/FSA account administrator or insurance company to determine eligibility.
References
1. Ferrandino RN, Chen S, Kappauf C, et al. Performance of liquid biopsy for diagnosis and surveillance of human papillomavirus–associated oropharyngeal cancer. JAMA Otolaryngol Head Neck Surg. doi:10.1001/jamaoto.2023.1937. 2. Hanna GJ, Roof SA, Jabalee J, et al. Negative predictive value of circulating tumor tissue modified viral (TTMV)-HPV DNA for HPV-driven oropharyngeal cancer surveillance. Clin Cancer Res 2023. doi: 10.1158/1078-0432.CCR-23-1478. 3. Berger BM, Hanna GJ et al. Detection of Occult Recurrence Using Circulating Tumor Tissue Modified Viral HPV DNA among Patients Treated for HPV-Driven Oropharyngeal Carcinoma. Clin Cancer Res 2022;28(19):4292–4301. 4. Chera BS, Kumar S, Shen C, et al. Plasma circulating tumor HPV DNA for the surveillance of cancer recurrence in HPV-associated oropharyngeal cancer. J Clin Oncol. Apr 1 2020;38(10):1050-1058. doi:10.1200/JCO.19.02444. 5. Lin MG, Zhu A, Read PW, et al. Novel HPV associated oropharyngeal squamous cell carcinoma surveillance DNA assay cost analysis. Laryngoscope. Nov 2023; 133:306-312. 6. Chera BS, Kumar S, Beaty BT, et al. Rapid clearance profile of plasma circulating tumor HPV type 16 DNA during chemoradiotherapy correlates with disease control in HPV-associated oropharyngeal cancer. Clin Cancer Res. Aug 1 2019;25(15):4682-4690. doi:10.1158/1078-0432.CCR-19-0211 7. International Agency for Research on Cancer. Human papillomaviruses. IARC monographs on the evaluation of carcinogenic risks to humans. Volume 90. Geneva, Switzerland: World Health Organization, 2007. 8. Mijares K, Ferrandino R, Chai R, et al. Circulating Tumor HPV DNA in Patients With Heand and Neck Carcinoma: Correlation With HPV Genotyping. Am J Surg Pathol. 2023:00:000-000. 9. Mirghani H, Moreau F, Lefevre M, et al. Human papillomavirus type 16 oropharyngeal cancers in lymph nodes as a marker of metastases. Arch Otolaryngol Head Neck Surg. Sep 2011;137(9):910-4. doi:10.1001/archoto.2011.141. 10. Gupta T, Master Z, Kannan S, et al. Diagnostic perfor¬mance of post-treatment FDG PET or FDG PET/CT imaging in head and neck cancer: a systematic review and meta-analysis. Eur J Nucl Med Mol Imaging38, 2083–2095(2011). doi.org/10.1007/s00259-011-1893-y. 11. Ang KK, Harris J, Wheeler R, et al. Human papillomavirus and survival of patients with oropharyngeal cancer. N Engl J Med. Jul 1 2010;363(1):24-35. doi:10.1056/NEJMoa0912217 12. Fakhry C, Zhang Q, Nguyen-Tan PF, et al. Human papillomavirus and overall survival after progression of oropharyngeal squamous cell carcinoma. J Clin Oncol. Oct 20 2014;32(30):3365-73. doi:10.1200/JCO.2014.55.1937 13. Gillison ML, Trotti AM, Harris J, et al. Radiotherapy plus cetuximab or cisplatin in human papillomavirus-positive oropharyngeal cancer (NRG Oncology RTOG 1016): a randomised, multicentre, non-inferiority trial. Lancet. Jan 5 2019;393(10166):40-50. doi:10.1016/S0140-6736(18)32779-X. 14. Elaldi R, Roussel LM, Gal J, et al. Correlations between long-term quality of life and patient needs and concerns following head and neck cancer treatment and the impact of psychological distress. A multicentric cross-sectional study. Eur Arch Otorhinolaryngol. Jul 2021;278(7):2437-2445. doi:10.1007/s00405-020-06326-8. 15. Kuhs KA, Brenner CJ, Holsinger CF, et al. Circulating tumor HPV DNA for surveillance of HPV-positive oropharyngeal squamous cell carcinoma, JAMA Oncol. doi:10.1001/jamaoncol.2023.4042. Published online October 12, 2023.