Provider Frequently Asked Questions
Find answers to the most common questions about NavDx® testing. If you don’t see the answer you need, contact our Clinical Operations Team at clinops@naveris.com or call (833) 628-3747.
How does the NavDx® test work?
The NavDx blood test is the first and most clinically validated circulating tumor tissue modified viral (TTMV®)-HPV DNA blood test that aids in the detection of HPV-driven cancers.6 TTMV-HPV DNA is released by tumor cells into the bloodstream of people with HPV-driven cancer and is a unique biomarker of tumors driven by human papillomavirus (HPV). The NavDx test analyzes the TTMV-HPV DNA fragments in a blood sample to provide a TTMV Score, reflective of the normalized TTMV-HPV DNA fragments per mL of plasma.6,7 NavDx testing has demonstrated ≥97% specificity and ≥89% sensitivity to more accurately detect disease status in HPV+ oropharyngeal squamous cell carcinoma (OPSCC) and ≥98.4% specificity and ≥82.8% sensitivity to more accurately detect disease status in HPV+ anal squamous cell carcinoma.4,7 NavDx testing reliably distinguishes TTMV-HPV DNA from non-cancerous sources of HPV DNA, regardless of tumor HPV integration status.6 The NavDx test can detect and identify the most prevalent high-risk HPV genotypes, including HPV-16, HPV-18, HPV-31, HPV-33, and HPV-35.6,9
Who are the appropriate patients to receive the NavDx test?
Any patients with HPV-driven oropharyngeal or anal cancer are appropriate candidates for NavDx testing. The NavDx test is currently being used to help Providers detect and monitor HPV-driven oropharyngeal and anal cancer. NavDx testing is used to confirm that the tumor is HPV+, to assess treatment response, and to detect recurrences, including in distant metastases. The test is also being studied for use in cases of HPV-driven cervical cancer. The clinical utility of NavDx testing has been validated in 47 peer-reviewed publications and proven in real-world practice, with over 120,000+ tests performed.10
Is NavDx available for patients with HPV+ cervical cancer?
NavDx is currently validated for HPV+ oropharyngeal squamous cell carcinoma and HPV+ anal squamous cell carcinoma. Research into its application for HPV+ cervical cancer is ongoing.
What are the recommendations for using the NavDx test?
Following definitive treatment, NavDx testing can reliably monitor for HPV-driven oropharyngeal and anal cancer recurrence during surveillance. Serial testing of TTMV-HPV DNA with the NavDx test demonstrated per-patient ≥98% negative predictive value and ≥95% positive predictive value for active HPV-driven oropharyngeal malignancy, and accurately detected biopsy-proven recurrence a median of 4 months earlier than imaging.6,8 In anal cancer, the NavDx test demonstrated per-patient ≥92.5% negative predictive value and ≥96% positive predictive value for active malignancy, and accurately detected biopsy-proven recurrence a median of 59 days earlier than imaging.4,5
While testing cadence is the decision of the Provider, please note that CMS coverage policy for surveillance allows NavDx testing at the following intervals:
HPV+ oropharyngeal cancer:
4 tests per year in years 1 and 2 post-treatment
2 tests per year in years 3, 4 and 5 post-treatment
HPV+ anal cancer:
4 tests per year in years 1, 2 and 3 post-treatment
2 tests per year in years 4 and 5 post-treatment
The California Head and Neck Consortium recently released its consensus recommendations on the use of ctDNA assays in HPV-driven oropharyngeal cancer. The paper provides guidance on when and how to use tools like the NavDx test.11 Access the paper here. → [link to https://ascopubs.org/doi/10.1200/OP-25-00450]
Can NavDx testing distinguish between cancerous and non-cancerous 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.6 NavDx testing has demonstrated a ≥97% specificity and ≥89% sensitivity to identify patients with newly diagnosed and non-metastatic HPV-driven oropharyngeal squamous cell carcinoma (OPSCC).6 The NavDx test uses 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
Does NavDx work for HPV genotypes other than HPV-16?
Yes. NavDx testing is designed to detect and identify the most prevalent high-risk HPV genotypes, including HPV-16, HPV-18, HPV-31, HPV-33, and HPV-35. These five genotypes account for the majority of HPV-driven cancers.
Can the NavDx test be used before treatment begins?
Yes. A pre-treatment NavDx test can confirm HPV+ tumor etiology, establish a TTMV-HPV DNA baseline, and identify the specific HPV genotype driving the cancer. Learn About Pre-Treatment Use Cases → [link to Pre-Treatment page]
Can NavDx testing be used when a biopsy is inconclusive or a primary tumor cannot be identified?
Recent expert consensus supports the use of ctHPVDNA to confirm HPV+ etiology in cases with indeterminate biopsies or occult primary cancers.11 Published studies suggest NavDx testing may help identify HPV+ disease in patients for whom standard tissue biopsy is non-diagnostic or inconclusive.14,15,16
Can the NavDx test be used during active treatment?
Yes. NavDx testing can be used during active treatment to help assess tumor response to therapy. Published studies in HPV-driven oropharyngeal cancer have shown that TTMV-HPV DNA clearance patterns during CRT are associated with disease control outcomes.7,13 NavDx testing during treatment should complement, not replace, standard clinical assessment. Learn About Use Cases During Treatment→ [link to During Treatment page]
What is the turnaround time for NavDx results?
NavDx results are typically available within 7 business days of blood sample receipt at the Naveris laboratory. Providers are notified through the Naveris Provider Portal when results are ready.
What information does the NavDx 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 TTMV Score.6,9 The NavDx results report includes your patient’s TTMV-HPV DNA status (positive, negative, or indeterminate), their TTMV Score, and their HPV genotype (if positive). The report features a graph that sequentially plots the patient’s TTMV Score for each NavDx test performed and a Results and Interpretation section that includes a brief qualitative interpretation of the test result. The easy-to-interpret, actionable NavDx results report helps inform clinical decisions so you can optimize HPV-driven oropharyngeal and anal cancer care. View a Sample Test Report → [link to Sample Test Report PDF]
What does an indeterminate NavDx result mean, and what should I do?
An indeterminate result means TTMV-HPV DNA was detected at a low level that does not meet the threshold for a definitive positive result. A clinical examination and consideration of imaging is recommended. Repeat NavDx testing in approximately 4–6 weeks may help clarify the result.
What is the CHNC consensus, and how does it apply to NavDx use?
The California Head and Neck Consortium (CHNC) is a multidisciplinary group of 33 HPV+ cancer specialists from 15 U.S. institutions. In 2025, the CHNC published consensus recommendations in JCO Oncology Practice on the clinical use of ctHPVDNA assays in HPV-driven oropharyngeal cancer. There was Strong Consensus among the participating members that ctHPVDNA tests like the NavDx test improve time to detection of HPV+ head & neck cancer recurrence compared to conventional surveillance tools. Key guidance includes timing for the first post-treatment ctHPVDNA test (3 months); serial surveillance cadence (every 3 months in years 1–2 and every 6 months in years 3–5); and a defined workflow for responding to positive results in the absence of clinical evidence of disease. The Consortium also recommends, as does Naveris, that ctHPVDNA testing should supplement, not replace, conventional surveillance tools.11 Access the paper here. → [link to https://ascopubs.org/doi/10.1200/OP-25-00450]
Is NavDx testing covered by insurance?
Medicare covers serial NavDx testing for surveillance of recurrence in patients with a history of documented HPV-driven oropharyngeal or anal cancer. The NavDx test is also covered by many commercial health insurance companies. Naveris 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 billing@naveris.com or (833) 628-3747.
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 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 copay, coinsurance, or deductible. Our 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. Learn More → [link to Patient Access Flashcard]