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    • Tracking Your TTMV Score
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In the management of HPV-driven OPSCC surveillance

Let Their Blood TTMV® Score Help Achieve a New Standard of Care

Monitoring TTMV-HPV DNA Scores with the NavDx test at routine surveillance visits
has demonstrated unrivaled test performance metrics1-3

Tumor tissue modified viral (TTMV)-HPV DNA is a unique biomarker released into the blood from tumors driven by human papillomavirus (HPV)4
  • ≥97% Specificity and ≥89% Sensitivity to more accurately detect true disease status1,2
  • ≥98% NPV with no recurrence when TTMV-HPV DNA Scores remained undetectable1,2
  • ≥95% PPV for cancer recurrence, when patients had 1 positive test result1,2
  • With unrivaled NPV and PPV, serial NavDx testing during surveillance could help optimize the use of imaging, by mitigating the need for unnecessary imaging exams1-3

NavDx surveillance testing, with its high PPV, can reduce the risk of unnecessary invasive procedures, whereas its high NPV can offer patients greater confidence in their response to treatment and current disease management.3,5

Start tracking your patients' TTMV Scores

Serial NavDx testing assists in earlier detection of patients with recurrent disease2,3

Why wait for physical symptoms to appear? A single positive TTMV-HPV DNA Score was the first indication of recurrence in 97% (57/59) of asymptomatic patients3 *†

Positive Score

*Of 1,076 patients tested during surveillance, 80 (7.4%) had at least one positive TTMV-HPV DNA Score. Of these, 59 (74%) had either indeterminant (IND) disease status or no evidence of disease (NED) at time of their positive test Score, while 21 (26%) were noted as having clinically active disease at time of their first positive Score. Nearly half, 38 (48%) were tested >12 months after completion of definitive therapy, while 27 (34%) and 15 (19%) were tested at 6-12 months, and 3-6 months, respectively.

†57 of the 59 (96.66%) patients with IND or NED status, who tested positive for TTMV-HPV DNA, were later proven to have recurrent disease (on imaging and/or biopsy), suggesting the presence of clinically occult recurrence at time of their positive test result. Longer follow-up was needed to identify recurrent cancer in 2 of the remaining 4 IND and NED patients under surveillance. All 21 patients with active disease reported at the time of TTMV-HPV DNA testing were confirmed to have recurrent disease.

NavDx testing reliably informs disease status enabling you to intervene earlier with imaging, physical exams, and salvage therapy; and reassure patients their disease is being effectively managed2,3

Learn more about routine NavDx Surveillance testing in OPSCC

Use NavDx testing to optimize the clinical management of HPV-driven cancer across the patient care continuum4

Pretreatment

CONFIRM the tumor HPV genotype4 and establish baseline TTMV Score

Learn More

During Treatment

ASSESS treatment response4

IDENTIFY the presence of molecular residual disease4

See the Data
Get started with NavDx testing

Optimize the clinical management of HPV+ oropharyngeal squamous cell carcinoma
(OPSCC) across the patient care continuum4,6,7

NavDx testing reliably informs disease status, enabling you to intervene earlier with imaging, physical exams and salvage therapy, and reassure patients their disease is being effectively managed.2,3

Order NavDx Tests for Your HPV+ Patients

Tumor tissue modified viral (TTMV)-HPV DNA is a unique biomarker of tumors driven by HPV.4

As human papillomavirus positive
(HPV+) tumor cells die, TTMV-HPV
DNA fragments are shed
into the blood

When tumor cells die, they release fragments of their DNA into the bloodstream. This circulating tumor DNA can be measured in blood samples and used to detect a tumor, guide tumor-specific treatment, and monitor for treatment response and cancer-free survival.4

The TTMV-HPV DNA biomarker is unique to human papillomavirus (HPV)-driven cancers like oropharyngeal squamous cell carcinoma (OPSCC), or anal squamous cell carcinoma (ASCC) and is specific to the HPV-genotype involved in the patients cancer diagnosis. HPV-16 is the most common genotype; however, other high-risk HPV genotypes include, HPV-18, HPV-31, HPV-33, and HPV-35.7

Monitoring changes in your HPV-positive cancer patients circulating TTMV-HPV DNA Scores can indicate molecular residual disease and cancer recurrence, enabling you to intervene earlier, which may result in improved outcomes4

Start tracking your patients' TTMV Scores

Start Optimizing
HPV+ Cancer Surveillance Today

Testing Schedule

Clinical practice guidelines and CMS coverage policy for recurrence detection include surveillance at specified intervals:

During Surveillance

Hollow Diamond ≤2 years post treatment: every 3 months

Hollow Diamond 3-5 years post treatment: every 6 months

Hollow Diamond 6+ years post treatment: 1 time per year

Naveris Provider Portal

An ordering experience that respects your time

Convenient Test Kit Ordering

Always be prepared - order NavDx Test Kits directly from the portal, for your practice

Streamlined ordering process

Complete, sign and submit test orders from our secure provider portal

Realtime access to order status, test results and patients’ testing histories

Review order status, receive and download test results,
and view testing histories for your patients

Automate serial testing during surveillance

The MRD Surveillance Notification Program enables you
to receive a patient's Test Requisition Forms (TRFs)
during surveillance, based on your specified intervals.

Naveris Provider Portal physician resources
blood draw truck

A simple blood draw, performed in-office or through our nationwide mobile phlebotomy services

  • Test sample requires one 10-mL tube of whole blood
  • For practices WITH blood collection capabilities, order NavDx test kits for delivery to your practice
  • For practices WITHOUT blood collection capabilities, patients may use our Mobile Phlebotomy Service for convenient, in-home blood collection

Optimize the clinical management of HPV+ head and neck cancer and reassure patients their disease is being effectively monitored by tracking their TTMV-HPV DNA Score with the NavDx blood test!

Order NavDx Test Kits

Optimize HPV+ Oropharyngeal Cancer Care with the NavDx Test Results Report

Easy-to-interpret, actionable test result helps inform clinical decisions

NavDX Test Result
  1. Quick summary of test findings
    The NavDx Test Result reports the patient's TTMV-HPV DNA status and the TTMV-HPV DNA Score.
  2. The graph
    Longitudinal plot of the patient’s TTMV-HPV DNA Score for each NavDx test.
  3. Test results and interpretation
    Results include:
  • TTMV-HPV DNA Score
  • Risk Score interpretation
  • Tumor HPV genotype

Naveris also provides a brief qualitative written interpretation of the test result

NavDx Sample Test Results Report

NavDx testing reliably informs disease status so you can optimize the utility of imaging, physical exams and therapy, reassuring patients their disease is being effectively managed.2,3

Optimize HPV+
cancer care
with comprehensive
resources and
support for your practice

Downloadable

Practice Resources

We’ve developed a range of useful tools to help you incorporate NavDx testing into your practice

View and Download
Resources

NavDx Testing in Clinical Practice

Review real-world cases to see how your peers are utilizing NavDx testing to help optimize HPV-driven oropharyngeal cancer care

View Cases
Video Library

Video Library

View our video library to learn more about the benefits of using the NavDx test in your clinical practice

See for Yourself
Downloadable

Publications

Review the latest publications to learn how NavDx testing is enabling physicians to optimize HPV+ cancer surveillance

View Publications

References
1. Ferrandino RN, Chen S, Kappauf C, et al. Performance of liquid biopsy for diagnosis and surveillance of human papillomavirus–associated oropharyngeal cancer. JAMA Otolaryngol Head Neck Surg. doi:10.1001/jamaoto.2023.1937. 2. Hanna GJ, Roof SA, Jabalee J, et al. Negative predictive value of circulating tumor tissue modified viral (TTMV)-HPV DNA for HPV-driven oropharyngeal cancer surveillance. Clin Cancer Res 2023. doi: 10.1158/1078-0432.CCR-23-1478. 3. Berger BM, Hanna GJ et al. Detection of Occult Recurrence Using Circulating Tumor Tissue Modified Viral HPV DNA among Patients Treated for HPV-Driven Oropharyngeal Carcinoma. Clin Cancer Res 2022;28(19):4292–4301. 4. Chera BS, Kumar S, Shen C, et al. Plasma circulating tumor HPV DNA for the surveillance of cancer recurrence in HPV-associated oropharyngeal cancer. J Clin Oncol. Apr 1 2020;38(10):1050-1058. doi:10.1200/JCO.19.02444. 5. Lin MG, Zhu A, Read PW, et al. Novel HPV associated oropharyngeal squamous cell carcinoma surveillance DNA assay cost analysis. Laryngoscope. Nov 2023; 133:306-312. 6. Chera BS, Kumar S, Beaty BT, et al. Rapid clearance profile of plasma circulating tumor HPV type 16 DNA during chemoradiotherapy correlates with disease control in HPV-associated oropharyngeal cancer. Clin Cancer Res. Aug 1 2019;25(15):4682-4690. doi:10.1158/1078-0432.CCR-19-0211 7. International Agency for Research on Cancer. Human papillomaviruses. IARC monographs on the evaluation of carcinogenic risks to humans. Volume 90. Geneva, Switzerland: World Health Organization, 2007. 8. Mijares K, Ferrandino R, Chai R, et al. Circulating Tumor HPV DNA in Patients With Heand and Neck Carcinoma: Correlation With HPV Genotyping. Am J Surg Pathol. 2023:00:000-000. 9. Mirghani H, Moreau F, Lefevre M, et al. Human papillomavirus type 16 oropharyngeal cancers in lymph nodes as a marker of metastases. Arch Otolaryngol Head Neck Surg. Sep 2011;137(9):910-4. doi:10.1001/archoto.2011.141. 10. Gupta T, Master Z, Kannan S, et al. Diagnostic perfor¬mance of post-treatment FDG PET or FDG PET/CT imaging in head and neck cancer: a systematic review and meta-analysis. Eur J Nucl Med Mol Imaging38, 2083–2095(2011). doi.org/10.1007/s00259-011-1893-y. 11. Ang KK, Harris J, Wheeler R, et al. Human papillomavirus and survival of patients with oropharyngeal cancer. N Engl J Med. Jul 1 2010;363(1):24-35. doi:10.1056/NEJMoa0912217 12. Fakhry C, Zhang Q, Nguyen-Tan PF, et al. Human papillomavirus and overall survival after progression of oropharyngeal squamous cell carcinoma. J Clin Oncol. Oct 20 2014;32(30):3365-73. doi:10.1200/JCO.2014.55.1937 13. Gillison ML, Trotti AM, Harris J, et al. Radiotherapy plus cetuximab or cisplatin in human papillomavirus-positive oropharyngeal cancer (NRG Oncology RTOG 1016): a randomised, multicentre, non-inferiority trial. Lancet. Jan 5 2019;393(10166):40-50. doi:10.1016/S0140-6736(18)32779-X. 14. Elaldi R, Roussel LM, Gal J, et al. Correlations between long-term quality of life and patient needs and concerns following head and neck cancer treatment and the impact of psychological distress. A multicentric cross-sectional study. Eur Arch Otorhinolaryngol. Jul 2021;278(7):2437-2445. doi:10.1007/s00405-020-06326-8. 15. Kuhs KA, Brenner CJ, Holsinger CF, et al. Circulating tumor HPV DNA for surveillance of HPV-positive oropharyngeal squamous cell carcinoma, JAMA Oncol. doi:10.1001/jamaoncol.2023.4042. Published online October 12, 2023.

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