Waltham, MA., October 12, 2023 –(BUSINESS WIRE)– Naveris, Inc., the leader in precision oncology diagnostics for viral-induced cancers, today announced the publication of two new peer-review studies in the journals Clinical Cancer Research (CCR) and JAMA Otolaryngology-Head & Neck Surgery (JAMA Head & Neck), which highlight the clinical utility of the company’s tumor tissue modified viral (TTMV®) DNA platform and add to a growing library of data supporting use of the company’s NavDx® blood test.
NavDx, Naveris’ proprietary flagship blood test for TTMV-HPV DNA, is the first and only clinically validated circulating tumor HPV DNA blood test that provides a non-invasive and precise method for detecting molecular residual disease (MRD) before there is clinical or radiographic evidence of cancer recurrence.
Negative Predictive Value of Circulating Tumor Tissue Modified Viral (TTMV)-HPV DNA for HPV-driven Oropharyngeal Cancer Surveillance (Hanna, G.J. and Roof S.A. et al.), published in CCR, is a retrospective observational cohort study involving 543 patients who completed therapy for HPV-driven oropharyngeal squamous cell carcinoma (OPSCC). As TTMV-HPV DNA testing has emerged as a biomarker that can accurately inform disease status, these patients were monitored using the NavDx test as part of routine surveillance for recurrence. In this study, the NavDx test yielded a per-patient negative predictive value of 98.4% and positive predictive value of 94.8% at a median of 2 years of follow-up.
“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,” said Glenn J. Hanna, MD, Director of the Center for Cancer Therapeutic Innovation at the Dana-Farber Cancer Institute, and co-first author of the study. “These markers of accuracy are valuable for physicians and providers to make confident treatment decisions and are of equal importance for patients’ mindsets.”
Performance of Liquid Biopsy for Diagnosis and Surveillance of Human Papillomavirus–Associated Oropharyngeal Cancer (Ferrandino, R. M., et al.), published in JAMA Head & Neck, also explored TTMV-HPV DNA for testing of patients with HPV-associated OPSCC, in order to establish the clinical efficacy of this testing in both the diagnosis and surveillance of the disease in daily practice. Researchers demonstrated that in routine clinical use the NavDx test demonstrated 100% specificity in both diagnosis and surveillance cohorts, with sensitivity of 91.5% and 88.4% in the diagnosis cohort and surveillance cohort, respectively.
Together these two new studies build upon significant prior literature supporting the validity and utility of NavDx for MRD detection and recurrence monitoring in HPV-driven OPSCC.
“NavDx has consistently exhibited stellar performance in well over a dozen peer-reviewed studies following thousands of HPV-driven OPSCC patients. Naveris’ TTMV-DNA testing platform continues to show strong performance and provides physicians and patients an accurate and trustworthy tool for helping to detect disease earlier,” commented Piyush B. Gupta, PhD, Founder, Executive Chairman, and Chief Science and Technology Officer of Naveris. “We congratulate these investigators on their outstanding research, and look forward to our ongoing partnerships with the clinical research community to support bringing NavDx testing to more patients.”
Naveris is a privately held, commercial stage, precision oncology diagnostics company with facilities in Massachusetts and North Carolina. Since its founding in 2017, Naveris has been committed to improving outcomes for the millions of people at risk of developing viral-induced cancers with novel molecular diagnostics that enable earlier cancer detection. The company operates high-complexity testing clinical laboratories that are accredited by the College of American Pathologists and the New York State Department of Health Wadsworth Center, and are certified under CLIA. For more information on Naveris and the clinical impact of NavDx, please visit www.naveris.com and www.NavDx.com. NavDx has not been cleared or approved by the US Food and Drug Administration (FDA).
ICR Westwicke Healthcare PR