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Frequently Asked Questions

Find answers to the most common questions about NavDx® testing. If you don’t see the answer you need, reach out to us.

Contact & Support

Provider FAQ

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. 

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]

If you didn’t find the answer you need or would like to talk to someone, our Clinical Operations Team can help. You can contact us at clinops@naveris.com or call (833) 628-3747.

Patient FAQ

What can the NavDx® test tell my Provider and me?

NavDx testing is currently being used to help Providers detect and monitor HPV+ head & neck and anal cancer. NavDx testing can provide more information than your physician can get from physical exams and imaging alone. Some of the questions NavDx testing can answer include:

Will the NavDx test tell me which type of HPV I have?

Yes. 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. The specific HPV genotype associated with your cancer will be included in the test report that goes to your Provider.

Who is appropriate for NavDx testing?

Any patient diagnosed with HPV+ head & neck cancer or HPV+ anal cancer may benefit from NavDx testing. With a simple blood draw, a NavDx test can detect whether HPV+ cancer is present in your body. By repeating the test over time, your Provider can see how well your treatment is working and whether your cancer has returned. Routine NavDx testing can detect cancer recurrence before it produces symptoms. Studies show that the test can detect HPV+ head & neck cancer a median of 4 months earlier than it can be seen on imaging 6 and HPV+ anal cancer a median of 59 days earlier than it can be seen on imaging.4

How can the NavDx test be used to help personalize my HPV+ cancer care?

NavDx testing can detect the presence of HPV+ cancer throughout your care journey. Before you start treatment, a NavDx test may be used to confirm the type of HPV associated with your cancer. The test also analyzes the amount of TTMV®-HPV DNA in your blood, to establish your TTMV Score. During your treatment, the test can be repeated to assess if the tumor is responding to treatment. Once your treatment has been completed, the test can determine whether any of the cancer is still in your body. Once you are in follow-up for recurrence monitoring, the test is repeated regularly as ordered by your Provider, to give you early warning if the cancer returns.

How often should I have a NavDx test?

When and how often you should be monitored with the NavDx test is up to you and your Provider.

If you are covered by Medicare, CMS coverage policy for recurrence monitoring allows NavDx testing at the following intervals:

HPV+ head & neck cancer:
4 tests per year in year 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

What are my options regarding where to get my blood drawn?

The NavDx test only requires a simple blood draw, which needs no special preparation on the patient’s part. The blood draw can be performed at your Provider’s facility, or you can use Naveris®-arranged Phlebotomy to have your blood draw completed at a walk-in clinic near you or at another convenient location, such as your home or workplace. Contact our Patient Navigation Team at support@naveris.com or (833) 628-3747 with questions or to set up Naveris-arranged Phlebotomy. Learn More → [link to NAP brochure]

Do I need to fast or prepare in any special way before my blood draw?

No special preparation is required. You may eat and drink normally before your NavDx blood draw. If you have questions about your blood draw appointment, contact the location where your draw will take place or contact our Patient Navigation Team at support@naveris.com or (833) 628-3747.

Can the NavDx test be used along with imaging scans to help monitor for cancer recurrence?

Yes, your Provider can use a combination of NavDx testing and imaging scans to monitor for cancer recurrence. Even with successful treatment, 15% to 25% of people with HPV+ head & neck cancer and 20% to 30% of people with HPV+ anal cancer have a recurrence within 5 years.11,12 Regular NavDx testing can help detect head & neck cancer recurrence a median of 4 months earlier than it can be found through imaging and anal cancer recurrence a median of 59 days earlier than it can be found through imaging.4,6

Does the NavDx test replace my imaging scans?

No. NavDx testing is designed to complement, not replace, imaging and clinical examinations. Your Provider may use NavDx testing alongside CT scans, PET scans, or other imaging to get a more complete picture of your cancer status. The NavDx test and imaging each provide different types of information, and using both together can help your Provider make more informed decisions.

How long does it take to get results?

NavDx results are typically available within 7 business days of your blood sample arriving at the Naveris laboratory. Your Provider will be notified through the secure Naveris Provider Portal when your results are ready.

What does a positive NavDx result mean?

A positive result means TTMV-HPV DNA was detected in your blood, which may indicate the presence of HPV-driven cancer activity. Your Provider will recommend appropriate next steps, which may include a physical exam, imaging, or additional testing. A positive result is a signal for your care team to investigate further; it is not a cancer diagnosis.

What does a negative NavDx result mean?

A negative result means no TTMV-HPV DNA was detected in your blood at the time of testing. In post-treatment surveillance studies, more than 98% of head & neck cancer patients and more than 92% of anal cancer patients with a negative NavDx result had no evidence of active cancer.1,2,4 Your Provider will continue monitoring you with regular NavDx testing and clinical exams according to your care plan.

What does an indeterminate result mean?

An indeterminate result means a small amount of TTMV-HPV DNA may have been detected, but not at a level sufficient to report as definitively positive or negative. Your Provider may recommend a physical exam, imaging, or a repeat NavDx test in a few weeks to help clarify the result. Many indeterminate results resolve with the next test. Your care team will recommend appropriate next steps. It is important not to ignore an indeterminate result.

Is the NavDx test the same as the HPV test my OB/GYN orders?

No, these are different tests. Cervical HPV screening detects the presence of HPV virus in the superficial cells lining the cervix and endocervical canal. The NavDx test detects TTMV-HPV DNA, a distinct cancer biomarker released into your bloodstream by HPV-driven cancer cells.

NavDx is also not used for cervical cancer screening (Pap testing). It is designed specifically to detect HPV-driven cancer in patients with HPV+ head & neck or HPV+ anal cancer.

If you didn’t find the answer you need or would like to talk to someone, our Patient Navigation Team can help. You can contact us at support@naveris.com or (833) 628-3747.

Insurance & Billing FAQ

Is there a CPT® code for NavDx® testing?

Yes. The NavDx test has a dedicated Proprietary Laboratory Analysis (PLA) code. The PLA code for NavDx testing is 0356U.

What is a PLA code?

Proprietary Laboratory Analyses (PLA) Codes are an addition to the CPT® code set approved by the American Medical Association. A PLA code applies to only one unique lab test made by a specific manufacturer or performed by a specific lab. Use of a PLA code allows labs to specifically identify their unique test when filing claims with insurance companies.

What is an MAAA code?

Multianalyte Assays with Algorithmic Analyses (MAAA) codes are a specialized subset of diagnostic tests that meet specific criteria for utilizing multiple results derived from various types of lab analysis. The results of these multiple lab analyses are then processed using an algorithm to develop a final test result, often reported in the form of a numeric score(s) or as a probability. MAAA codes are often assigned to some of the most advanced laboratory diagnostic tests.

The NavDx test code is an MAAA code because it employs multiple lab analytes that are then input into our proprietary algorithm to produce a TTMV Score, which is the result that is reported to physicians and patients.

How much does a NavDx test cost?

Naveris® is committed to ensuring that NavDx testing is accessible to patients by providing support services, as well as financial assistance to those who qualify. Our Billing Team works with patients to navigate cost-associated barriers to testing. The cost of NavDx testing depends on your insurance plan and whether or not you have reached your out-of-pocket deductible or co-insurance limits. You are only financially responsible for the insurance plan-associated costs for a NavDx test (such as copays, coinsurance, or deductibles); the amount of these payments is based on the terms of your insurance plan. If you have questions or want to learn more about the cost of the NavDx test, please contact our Patient Insurance Support Team at billing@naveris.com or (833) 628-3747.

What is the billing process after my test is completed?

Naveris manages the billing process for patients. After a NavDx test report is sent to your doctor, Naveris will submit a claim (a bill) to your insurance plan. For some insurance plans, Naveris may contact you to get required information before we can submit a claim. You may receive notification of the claim submission to your insurance plan.

You may then receive an Explanation of Benefits (EOB) from your insurance plan (print or electronically). An EOB is not a bill for you to pay. An EOB is a statement from your insurance plan that describes the amount that your insurance company will pay for a NavDx test and the amount that you are responsible for paying (copays, coinsurance, or deductibles).

Once Naveris is informed by your insurance plan of the amount that you are financially responsible for paying, Naveris will send you a bill for that amount.

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, and we are continually pursuing and gaining coverage to ensure patients have access to the test. In the event NavDx testing is not covered by a patient’s insurance plan, Naveris may appeal to the insurance company on the patient’s behalf. Please contact our Patient Insurance Support Team at billing@naveris.com or (833) 628-3747 with any questions about insurance coverage or billing policies.

What if my insurance denies coverage?

If NavDx testing is not covered by your insurance plan, Naveris will appeal to your insurance company on your behalf at no additional cost to you. Our Patient Insurance Support Team manages this process and will keep you informed. For questions, contact billing@naveris.com or (833) 628-3747.

How long does it take to receive a bill after my test?

After your NavDx results are reported to your Provider, Naveris submits a claim to your insurance. Your insurance processes the claim and notifies Naveris of any amount you are responsible for (you are only financially responsible for your insurance plan-associated costs for the NavDx test, such as copays, coinsurance, or deductibles). Naveris then sends you a statement for that amount only. Timelines vary by insurance plan. For questions about a specific claim, contact our Patient Insurance Support Team at billing@naveris.com or (833) 628-3747.

Can I self-pay for NavDx if I don’t have insurance?

Yes. Patients without insurance or with limited coverage may be eligible for financial assistance through the Naveris Cares™ program. Our Patient Insurance Support Team works directly with uninsured patients to explore available options so that cost is not a barrier to testing. Contact us at billing@naveris.com or (833) 628-3747 to discuss your situation.

Does Medicare cover NavDx for anal cancer?

Yes. Medicare covers serial NavDx testing for surveillance of recurrence in patients with a documented history of HPV+ anal squamous cell carcinoma who currently have no evidence of disease, starting one day following surgery or 7 days following completion of chemotherapy, radiation therapy, and/or immunotherapy. Coverage allows up to 4 tests per year in years 1 through 3, and 2 tests per year in years 4 and 5.

If you didn’t find the answer you need or would like to talk to someone, contact our Patient Insurance Support Team at billing@naveris.com or (833) 628-3747.

References

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