In November, Medicare coverage was established for the NavDx® test to be used in the surveillance of patients with previously treated anal squamous cell carcinoma (ASCC). In this article we share information for patients and caregivers
What is the NavDx test?
The NavDx® test, developed and performed exclusively by Naveris®, is the first and most clinically validated blood test that can detect the presence of HPV+ anal squamous cell carcinoma (ASCC) before there is clinical or radiographic evidence of cancer recurrence. The non-invasive, highly accurate test identifies fragments of tumor related HPV DNA in your blood that alerts your medical team to possible cancer recurrence.
Who is eligible for the test, and when is it typically used for anal squamous cell carcinoma?
The test is available to all patients in the United States with HPV+ ASCC (as well as HPV+ head and neck cancer), but commercial insurance coverage will vary, depending on patients’ healthcare plans. NavDx testing for the ASCC clinical indication in surveillance was recently approved as a covered benefit for those on Medicare.
Generally, the test can be used at the following points of care:
- For recurrence monitoring: Following treatment, your medical team can use the test in combination with traditional monitoring tools, like digital exams, imaging or anoscopy to evaluate whether you remain cancer-free or if your cancer may be returning.
- Pre-treatment: Some doctors use the NavDx test at the time of initial diagnosis to get a baseline result to which they can compare your later results, but this is not required to use the test for post-treatment monitoring. This can help them see how well or how quickly you’ve responded to your treatments. It can also help them confirm the HPV positivity and genotype of your cancer.
- During Treatment or in the Peri-Treatment Window: Some doctors like to have a test completed during treatment or immediately following treatment. As mentioned above, they compare this result to your pre-treatment result to see how well or how quickly you’ve responded to treatment.
What led to this new coverage approval?
New cases of ASCC arise in nearly 11,000 people in the United States each year, with approximately 90% of cases driven by HPV infection. The incidence of ASCC has been steadily rising, driven in part by demographics and increased prevalence among immunocompromised populations, including people living with HIV. Up to 30% of patients will experience recurrence following treatment, and current monitoring methods are often limited by inconclusive results or a lack of access, especially for underserved populations. These challenges underscore the urgent need for more accurate and accessible testing that enables earlier detection of recurrence.
What clinical evidence supported the decision by Medicare?
The recent Medicare coverage determination follows the publication of a multi-institutional study published earlier this year in Cancers that showed that the NavDx test detects ASCC recurrence with high accuracy and reliability a median of ~2 months earlier than standard surveillance methods. The same study showed that the test can also help accurately resolve 94% of inconclusive physical exam and imaging findings.
What is the recommended protocol for using the NavDX test in patient monitoring and follow-up?
How and when a NavDx test is performed is really a decision between a patient and their physician. However, for example, Medicare covers four tests annually during HPV+ ASCC recurrence surveillance in the first three years post-treatment, and two tests annually thereafter, up to five years post-treatment.
How does the test fit into existing surveillance. Does it replace or complement current methods like imaging or exams?
Existing surveillance methods for ASCC have significant drawbacks for patients. They can be inaccurate and uncomfortable due to localized scarring, inflammation, pain, or slow tumor regression. These methods are often located at larger institutions, which makes access difficult for many patients. Imaging and digital exam can miss recurrence outside of the area being examined or if the tumor is too small. These are just some examples.
The NavDx test, however, does not share these drawbacks. But while it is accessible, reliable, and non-invasive, it is a complement to existing surveillance methods—not a replacement.
What does a “positive” result mean for an anal cancer patient, and what happens next?
A positive result means that the test found tumor DNA in your blood. But it does not automatically mean your cancer has returned. It could mean tumor cells are still present in your body (for example, if your tumor is still regressing). Or it could mean that your cancer is returning, but only your doctor can tell you for certain. Your doctor may follow up with immediate physical exam and imaging to check for recurrence. If no recurrence is found or suspected, your doctor may just choose to follow you more closely.
What does a “negative” result mean for an anal cancer patient?
A negative result means the test did not find any measurable tumor DNA in your blood at the time of the blood draw. This is reassuring news and suggests there was no cancer activity at the time of the blood draw. However, it is important to continue with all of your regular follow-up and surveillance appointments. A single, or even multiple, negative test is not an “all clear.”
What does this Medicare coverage approval mean for patients with anal cancer?
Offering the NavDx test as a covered benefit through Medicare goes even further toward making accurate, non-invasive testing accessible to as many patients as possible. It also represents a major step forward in care for patients with HPV+ cancers. By identifying recurrence earlier, the NavDx test allows the medical team to intervene sooner, potentially improving outcomes for patients with disease recurrence while also offering peace of mind to patients who remain recurrence-free.
How might the test influence treatment decisions or follow-up care?
The NavDx test is not recommended for use in aiding treatment decisions. Its intended use is for disease activity monitoring and, occasionally, as an aid to diagnosis (e.g. HPV confirmation and genotyping).
It may influence follow-up care in the case of patients who have positive test results but for whom no evidence of disease can yet be found on physical exam or imaging. In these cases, the medical team may alter their surveillance schedule/routine to monitor them more closely/frequently or use more intensive imaging to watch for evidence of recurrence.
How can a patient access the NavDX test? Does it need to be ordered by their oncologist?
The NavDx test must be ordered by someone on your medical team. While that is often the medical oncologist or radiation oncologist, it could be any medical professional on your team, including your primary care physician. As a blood test, it is available to patients in any setting where a blood draw can be completed—no specialist required! Naveris can even arrange for you to go to a local walk-in lab or have their mobile lab come to your home for your blood draw.
Where can anal cancer patients learn more or find educational resources about the test and MRD?
To learn more about the NavDx test, visit www.navdx.com
This article was written in partnership with Naveris, a lead supporter of the 2025 Anal Cancer Patient Summit. Rewatch the sessions from the 2025 event
This content is provided for general educational purposes only and is not intended as medical advice. Always consult a qualified healthcare professional regarding any medical concerns or decisions.
