Review our FAQs to get more information about the NavDx test and other related topics
What is the NavDx blood test?
The NavDx blood test is a blood test for cancers associated with human papillomavirus (HPV) infection. Long-lasting
infections with high-risk HPV can cause cancer in parts of the body where HPV infects cells, such as
in the mouth and throat (oropharyngeal cancer), in the anus, or in the uterine cervix. NavDx testing detects
and analyses the tumor tissue modified viral (TTMV®)-HPV DNA fragments released by dying
cancer cells, to provide a TTMV Score.
NavDx testing is currently being used to help physicians detect and monitor HPV-positive oropharyngeal (head and neck) and anal cancer. Monitoring your blood TTMV Score provides more information than your physician can get from imaging alone:
NavDx testing is currently being used to help physicians detect and monitor HPV-positive oropharyngeal (head and neck) and anal cancer. Monitoring your blood TTMV Score provides more information than your physician can get from imaging alone:
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- Is my cancer due to HPV?
- Has my treatment worked and is my cancer gone? Has my cancer returned (even if I do not have symptoms and my imaging is clear)?
What role does blood TTMV-HPV DNA have in the management of HPV-positive cancer
care?
Some cancers are caused by a long-term infection with human papillomavirus (HPV). These tumors may
occur in the mouth and throat (oropharyngeal cancer), in the anus, or in the uterine cervix. The cells
of these tumors contain modified HPV DNA. As these cells die, they release tumor tissue
modified viral (TTMV)-HPV DNA into the blood. The NavDx blood test measures the TTMA-HPV DNA fragmentation pattern in a blood sample (referred to as your TTMV Score). NavDx testing
can tell your physician whether your oropharyngeal or anal cancer is HPV-positive, whether your cancer
is responding to treatment, whether any cancer is left in your body, and whether it has returned after
you have completed treatment.
Numerous studies have shown that NavDx testing accurately and reliably predicted when cancer returned. Among post-treatment patients:
Numerous studies have shown that NavDx testing accurately and reliably predicted when cancer returned. Among post-treatment patients:
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- ≥98% of people whose TTMV score remained negative had no cancer recurrence
- ≥95% of people with one positive TTMV score had recurrence
Who is appropriate for NavDx testing?
The NavDx blood test is a test for tumors that are positive for human papillomavirus (HPV). Any patient previously
diagnosed with HPV-positive head and neck cancer (cancer of the mouth and
throat), or HPV-positive anal cancer, may benefit from NavDx testing. With a simple blood draw,
a NavDx test can detect whether HPV-positive cancer is present in your body. The results of the
NavDx test help your physician create the best treatment plan for you. By repeating the test over
time, your physician can see how well your treatment is working, and whether your cancer has returned.
Routine NavDx testing of the TTMV-HPV DNA biomarker can detect cancer recurrence before it produces symptoms, and a median of 4 months earlier than it can
be seen on imaging.
What information can the NavDx blood test provide?
The NavDx test is a blood test for tumor tissue modified viral (TTMV)-HPV DNA. TTMV-HPV DNA is found only in
people with HPV-positive cancers. These cancers can occur in the back of the mouth and throat
(oropharyngeal or head and neck cancers), in the anus, and on the uterine cervix. NavDx can measure
the TTMV-HPV DNA fragmentation pattern in a blood sample (referred to as your TTMV Score). NavDx testing is
currently being used to help physicians detect and monitor HPV-positive oropharyngeal (head and neck)
and anal cancer. This test can show whether you have an HPV-positive tumor, if your tumor is
responding to treatment, whether some of the tumor is still in your body, and whether the tumor has
returned. After treatment, NavDx surveillance testing can accurately detect HPV-positive cancer recurrence, even before symptoms appear. Routine
monitoring of your TTMV Score gives physicians a more complete picture of your cancer than they can
get from imaging scans alone. Thus, routine NavDx testing of the TTMV-HPV DNA biomarker can help your physician create the best treatment plan for you.
How can the NavDx blood test be used to help personalize my HPV-positive cancer care?
NavDx testing can detect the presence of TTMV-HPV DNA in your blood during every phase of care for HPV-driven
cancers, like those of the throat and mouth or anal cancer. Before you start treatment, a NavDx test is 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, and to determine whether any of the cancer is still in
your body. After treatment, the test is repeated regularly as ordered by your doctor, to give you early warning if the cancer
returns.
Numerous studies show that NavDx testing accurately predicted when cancer returned. Among post-treatment patients:
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- ≥98% of people whose TTMV Score remained negative had no cancer
- ≥95% of people with one positive TTMV Score had recurrence
What will my physician learn from the NavDx blood test results?
Your NavDx test results provide important information about your TTMV Score that you can’t get from any other source. Your physician will use the NavDx blood test to reliably measure and monitor changes in your TTMV Score during your care. Since the NavDx test is highly accurate, you can be assured that your physician will have reliable information to effectively manage your disease.
Can the NavDx blood test be used along with imaging scans to help monitor for cancer recurrence?
Yes, your physician can use a combination of NavDx TTMV-HPV DNA testing and imaging scans to monitor for cancer recurrence.
Even with successful treatment, 13% to 25% of people with HPV-positive head and neck cancer have a recurrence within 5 years. Regular NavDx testing can help detect cancer recurrence a median of 4 months earlier than it can be found through imaging, biopsies, or symptoms. Published studies showed that, the NavDx blood test accurately predicted when cancer returned. Among post-treatment patients:
Even with successful treatment, 13% to 25% of people with HPV-positive head and neck cancer have a recurrence within 5 years. Regular NavDx testing can help detect cancer recurrence a median of 4 months earlier than it can be found through imaging, biopsies, or symptoms. Published studies showed that, the NavDx blood test accurately predicted when cancer returned. Among post-treatment patients:
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- ≥98% of people whose TTMV Score remained negative had no cancer
- ≥95% of people with one positive TTMV Score had recurrence
How often should I have a NavDx test?
When and how often your blood TTMV Score is monitored with NavDx is up to you and your physician.
- Before treatment
- During treatment
- After treatment (monitoring for cancer recurrence):
- ≤2 years post treatment: every 3 months
- 3-5 years post treatment: every 6 months
- 6+ years post treatment: 1 time per year
What are my options regarding where to get my blood drawn?
A simple blood draw may be performed in your physician’s office, at a walk-in facility or through our nationwide Mobile Phlebotomy Service. Contact Client Services with questions by emailing support@naveris.com or calling (833) 628-3747.
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.
What 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 Naveris Billing team works with patients so that cost is not a barrier 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 deductible or coinsurance payments); 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 Billing team at (833) NAVERIS or email us at billing@naveris.com.
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 (deductibles or coinsurance payments).
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.
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 (deductibles or coinsurance payments).
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.
If you didn’t find the answer you need or would like to talk to someone, our Client Services team can help. You can call (833) 628-3747 or email us at support@naveris.com