New Naveris Studies Show Potential for Viral DNA as a MRD Marker in Oropharyngeal Cancers
Naveris, Inc., a liquid biopsy company focused on viral-induced cancers, has unveiled two new peer-reviewed studies published in Clinical Cancer Research (CCR) and JAMA Otolaryngology-Head & Neck Surgery (JAMA Head & Neck) journals. These studies provide evidence for the clinical value of the company’s tumor tissue modified viral (TTMV®) DNA platform and NavDx® blood test.
NavDx is a liquid biopsy based blood test for TTMV-HPV DNA, is the only clinically validated circulating tumor HPV DNA blood test. Tumor tissue modified viral (TTMV®)-HPV DNA is a distinctive biomarker linked to HPV-driven cancers, such as oropharyngeal cancer. It is released into the blood by dying tumor cells. Measuring blood TTMV Score provides physicians with valuable insights into the condition of HPV-positive (HPV+) cancer in patients. The test offers a non-invasive and highly accurate means of detecting molecular residual disease (MRD) prior to the emergence of clinical or radiographic signs of cancer recurrence. Every year in the U.S. there are approximately 55,000 new cases of oropharyngeal cancer.
The first study, titled “Negative Predictive Value of Circulating Tumor Tissue Modified Viral (TTMV)-HPV DNA for HPV-driven Oropharyngeal Cancer Surveillance,” as published in CCR, was a retrospective observational cohort study involving 543 patients who had undergone treatment for HPV-driven oropharyngeal squamous cell carcinoma (OPSCC). During routine recurrence monitoring, these patients underwent NavDx testing, and the study demonstrated a per-patient negative predictive value of 98.4% and a positive predictive value of 94.8% after a median follow-up period of 2 years.
The second study, “Performance of Liquid Biopsy for Diagnosis and Surveillance of Human Papillomavirus–Associated Oropharyngeal Cancer,” published in JAMA Head & Neck, delved into TTMV-HPV DNA testing for patients with HPV-associated OPSCC, aiming to establish the clinical effectiveness of the testing procedure in diagnosis and disease surveillance in daily practice. Researchers demonstrated that in routine clinical use, the NavDx test exhibited 100% specificity in both the diagnosis and surveillance cohorts, with sensitivity rates of 91.5% and 88.4% in the diagnosis and surveillance cohorts, respectively.
Dr. Glenn J. Hanna, Director of the Center for Cancer Therapeutic Innovation at the Dana-Farber Cancer Institute and co-first author of the study, emphasized the importance of these results for both medical professionals and patients. “In our study, we saw that the TTMV-HPV DNA test provided very high negative and positive predictive values for the absence or presence of disease, respectively, with few missed cases,” he noted.