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New Multicenter Study Highlights Use of the NavDx® Test in Resolving Clinically Indeterminate Findings

By June 27, 2024No Comments
Data Adds to Substantial Body of Evidence Demonstrating NavDx’s Important Role in Oropharyngeal Cancer Surveillance

 

WALTHAM, Mass. (June 27, 2024) – Naveris, Inc., the leader in precision oncology diagnostics for viral-induced cancers, in collaboration with eight prominent U.S. institutions, announces the publication of a significant study, “Utility of TTMV-HPV DNA in resolving indeterminate findings during oropharyngeal cancer surveillance”, in Oral Oncology. The study highlights the crucial role of Naveris’ flagship product, the NavDx test, in enhancing diagnostic precision and clinical decision-making in surveillance of HPV-associated oropharyngeal cancer. The NavDx test is the first and only clinically validated circulating Tumor Tissue Modified Viral (TTMV®)-HPV DNA blood test.

The study addresses the frequent occurrence of clinically indeterminate findings (CIFs) during cancer surveillance, which can lead to overtreatment and psychological stress for patients. The retrospective cohort study included 543 patients treated for HPV-associated oropharyngeal cancer between February 2020 and January 2022.

“Our findings support the utility of circulating TTMV-HPV DNA in resolving indeterminate disease status and informing the subsequent clinical course,” said Dr. Scott A. Roof, MD, lead author and Assistant Professor in the Department of Otolaryngology Head and Neck Surgery at the Icahn School of Medicine at Mount Sinai. “TTMV-HPV DNA testing demonstrated high accuracy in correctly determining recurrence status, providing a reliable tool for managing HPV-associated oropharyngeal cancer.”

Key results from the study include:

  • Among the 543 patients, 39% experienced one or more clinically indeterminate findings based on standard-of-care during surveillance, where the results of a clinical exam or imaging test could not be definitively categorized as positive or negative for recurrence. In contrast, only 3% of patients had indeterminate NavDx test results during surveillance.
  • NavDx testing showed a high accuracy rate of 98% in resolving these indeterminate clinical disease statuses and correctly predicting the presence or absence of recurrence.
  • Discordance between NavDx and clinical results was minimal, with only 0.6% of patients showing ongoing positive tests without clinical evidence of recurrence.

Dr. Glenn J. Hanna, MD, senior author and Associate Professor of Medicine at Harvard Medical School and Director for both the Center for Cancer Therapeutic Innovation (Early Drug Development Program) and Center for Salivary and Rare Head and Neck Cancers at the Dana-Farber Cancer Institute added, “This study highlights the potential of circulating TTMV-HPV DNA as a robust biomarker to resolve clinical uncertainties, thereby minimizing unnecessary procedures and improving patient outcomes.”

This new data emphasizes the importance of accurate and reliable surveillance tools, especially in the context of HPV-associated oropharyngeal squamous cell carcinoma. The results of this study also demonstrate that NavDx testing can enhance existing surveillance protocols, helping healthcare providers make more informed management decisions, reduce patient anxiety, and potentially optimize treatment protocols.

About Naveris

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).

Contacts

Naveris Media Inquiries
support@naveris.com

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