Naveris is now CareDx. Advancing viral-mediated cancer care through precision medicine diagnostics. Read More

FOR HEALTHCARE PROVIDERS TREATING HPV+ CANCER

Know Earlier.

Act Sooner.

A Liquid Biopsy That Works

Like Your Patients Need It To.

The NavDx® test is the first and most clinically validated liquid biopsy that can detect HPV-driven oropharyngeal squamous cell cancer (OPSCC) and HPV-driven anal squamous cell cancer (ASCC), in many cases months before it shows up in clinical exams or on imaging. With a simple, non-invasive blood draw, the NavDx test can give you clear, quantified insight into your patient’s cancer status, at the molecular level and across the care continuum.

Purpose-Built for HPV+ Cancer.

Conventional circulating tumor DNA (ctDNA) tests look for somatic mutations in human DNA shed by tumor cells. This approach works across many cancer types but faces an inherent challenge: Because mutated DNA fragments are rare against the vast volume of the patient’s normal DNA, sensitivity can be limited when tumor burden is low, precisely the stage at which early detection matters most. And, in the case of HPV-driven cancers, somatic mutations are rare.

The NavDx test takes a fundamentally different approach. TTMV-HPV DNA is released into the blood exclusively by HPV-driven tumor cells undergoing apoptosis, not by normal tissue. It is a stable, predictable, viral biomarker that is released by every HPV-driven tumor, regardless of how the individual cancer evolved. Every patient with HPV+ cancer carries the same viral cancer driving genes. That means the NavDx test does not need to be customized to each patient’s unique tumor profile. It was engineered with a singular purpose: To detect HPV+ cancer, with exceptional precision.

No somatic mutation profiling required. No pan-cancer adaptation. The NavDx test was designed specifically for the biology of HPV-driven cancer, and that specificity is what drives its performance.

How Does the

NavDx Test Work?

The highly sensitive NavDx test is specifically engineered to find and measure circulating tumor tissue modified viral HPV DNA (TTMV-HPV DNA) in a patient’s blood sample. TTMV-HPV DNA is an HPV-positive cancer-specific biomarker. It is found only in people with active HPV-driven cancer and is distinct from non-cancerous HPV DNA, making it a precise target for detection.7 The TTMV-HPV DNA biomarker is also specific to the HPV genotype involved in the patient’s cancer. The test detects HPV-16 (the most common genotype), HPV-18, HPV-31, HPV-33, and HPV-35.21 The NavDx test is not an HPV test; it does not detect active HPV infection that is unrelated to an HPV+ cancer.

Which Patients Should

Have NavDx Testing?

NavDx testing may be appropriate for patients who have been:

  • Diagnosed with HPV-driven OPSCC or ASCC (at any stage of care)
  • Treated for HPV+ OPSCC or ASCC and entering post-treatment surveillance
  • Flagged with indeterminate imaging results that require further clarification (during surveillance for HPV+ OPSCC or ASCC)

When Is the NavDx Test Used?

The NavDx test can be integrated at multiple stages of HPV+ cancer management. You and your clinical team determine which application, or combination of applications, is appropriate for each patient.

Surveillance

The most common use for NavDx

  • Detect recurrence earlier with high-confidence positive results
  • Provide reassurance with high-confidence negative results

Learn More →

During Treatment

 

  • TTMV-HPV DNA clearance kinetics during CRT
  • Identify molecular residual disease

Learn More →

Pre-Treatment

 

  • Confirm etiology of the HPV-driven cancer
  • Identify the HPV genotype of the tumor

Learn More →

A pre-treatment test is not required to use the NavDx test at other points in the care journey. Monitoring with the NavDx test can be started at any time.

Simple, Actionable Reporting.

NavDx results are typically delivered within 7 business days of sample receipt at the Naveris lab and presented in an easy-to-interpret report that includes:

  • TTMV-HPV DNA status (detected / not detected)
  • TTMV Score
  • HPV genotype
  • A longitudinal plot of the patient’s TTMV Score over time
  • A brief qualitative interpretation of the result

Reports are available via the Naveris Provider Portal or available via customized reporting preferences.

What Is a TTMV Score?

A TTMV Score is the unique result generated by a NavDx test. It reflects the number and size of the TTMV-HPV DNA fragments in a patient’s blood sample. Tracking changes in a patient’s TTMV Score over time gives you objective molecular information to inform clinical decisions, from pre-treatment genotyping to long-term, post-treatment surveillance.

The Most Comprehensive Evidence Base in HPV+ Cancer Testing.

We are focused exclusively on HPV+ cancer. No other liquid biopsy test has been studied as deeply,

in as many patients, across as many clinical settings for this disease.

58
+
peer-reviewed publications10
40,000
+
patients tested10
120,000
+
tests performed10

Five Reasons Providers Choose the NavDx Test.

1. Earlier detection of recurrence.

Molecular evidence of recurrence can appear before clinical symptoms or imaging findings. Published data show that the NavDx test can detect recurrence a median of 4 months earlier than imaging in OPSCC 6,8 and a median of ~2 months earlier in ASCC.4 Earlier detection may expand salvage therapy options, including the possibility of less aggressive interventions.

 

2 High test accuracy.

NavDx testing demonstrates high specificity, sensitivity, positive predictive value (PPV), and negative predictive value (NPV) in both OPSCC and ASCC. A high NPV means a negative TTMV Score can provide meaningful reassurance that no detectable disease is present at the time of testing. A high PPV means a positive result is strongly associated with recurrent disease. The NavDx test’s strong performance profile delivers clinical confidence with every result. See full performance metrics→

 

3. Reduction in unnecessary imaging.

Because of its high diagnostic accuracy, routine NavDx surveillance testing may help optimize the use of imaging, reducing unnecessary PET/CT scans for patients with consistently negative TTMV Scores, while prioritizing imaging when a positive result warrants it. NavDx testing can also reduce the need for repeat imaging when imaging results are indeterminate—a common scenario in both OPSCC and ASCC. Published data shows NavDx testing can accurately resolve clinically indeterminate findings in OPSCC 97% of the time 39 and ≥92% of the time in ASCC. 4,5

4. Backed by the deepest evidence base of any liquid biopsy in HPV+ cancer.

Naveris® focuses exclusively on HPV+ cancer. Our singular focus has produced the most comprehensive clinical evidence base in this disease space, spanning pre-treatment through multi-year post-treatment surveillance, across two cancer types, at institutions nationwide. See Peer-Reviewed Publications→

 

5. Meaningful value for your patients.

For patients living with fear of recurrence, a NavDx result is not just a clinical data point; it is a meaningful answer. A negative result provides measurable reassurance that eases anxiety. A positive result, when acted on early, can mean more options and less aggressive treatment. Providers who use NavDx report that patients find value in having an objective monitor of their cancer status between visits. See Providers’ experience with the NavDx test reducing patient anxiety→

Coverage and Financial Assistance.

NavDx testing is covered by a growing number of commercial insurance companies, as well as Medicare for specific indications. Financial assistance is available to those who qualify.

Learn More

References

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