NATICK, Mass.–(BUSINESS WIRE)–Naveris, Inc., a leader in molecular diagnostics for viral cancers, today announced that the company and the principle investigator at Mayo Clinic will present its award-winning abstract at the American Society for Radiation Oncology (ASTRO) Annual Meeting held October 23-26, 2022. This presentation describes significant new data supporting the clinical value of NavDx®, the first and only clinically validated circulating tumor-tissue-modified HPV (TTMV®) DNA blood test, as a non-invasive blood test to assess the risk of disease recurrence after treatment in patients with human papilloma virus (HPV)-driven head and neck cancer. David Routman, M.D. radiation oncologist, Mayo Clinic, and first author of the study, was honored with the ASTRO Basic/Translational Science Award for this work.
This study investigated use of the NavDx test to detect molecular residual disease (MRD) following treatment in patients with head and neck cancer, as part of the phase III MC1675 clinical trial. NavDx-detected MRD was a significant risk factor for cancer recurrence. The presence of MRD, both in the post-operative setting and at 3 months post-treatment, was significantly associated with shorter progression-free survival. Of patients with a positive NavDx test at 3 months post-treatment, 75% developed recurrence by 18 months, whereas only 2.8% of patients with a negative NavDx test at 3 months post-treatment developed recurrence within the same time period. Results from the MC1675 trial were initially presented at the ASTRO 2021 annual meeting and follow-up is ongoing.
Naveris and Mayo Clinic are continuing their collaboration with the recently announced DART 2.0 prospective clinical trial (NCT05541016), which will investigate the value of TTMV-HPV DNA as a biomarker and the ability of NavDx to directly inform treatment decisions for patients with HPV-driven head and neck cancer.
“Naveris’ collaboration with the Mayo Clinic illustrates how advances in molecular diagnostics are creating paradigm shifts in the fight against cancer,” said Piyush Gupta PhD, Founder and CEO of Naveris. “We are delighted to be partnering with Drs. Ma, Routman, Van Abel and their colleagues on this groundbreaking clinical research, which aims to improve patient outcomes while reducing the side-effects and morbidity of medical treatment.”
“This report validates NavDx as a valuable tool after surgery for assessing the risk of post-operative cancer recurrence in these patients, which enables early diagnostic and therapeutic interventions,” said Barry M. Berger MD, Chief Medical Officer of Naveris.
More information on Naveris and NavDx can be found at booth #2348, or look for highlights from #ASTRO22 Twitter and LinkedIn. The data presented will be made available on the Naveris website at www.naveris.com/clinical-publications/.
Presentation details:
Abstract #140: ctHPVDNA and Recurrence Risk in MC1675, a secondary analysis of a Phase III Evaluation of De-escalated Adjuvant Radiation Therapy (DART) versus Standard Adjuvant Treatment for HPV Associated Oropharyngeal Squamous Cell Carcinoma (OPSCC)
Presenter: David Routman, MD, Mayo Clinic
Session Title: Variations on a Theme: De-Intensification Strategies for HPV+ Oropharynx Cancer
Session Date & Time: Monday, October 24, 2022, 10:45AM-12:00PM (CDT) / 11:45AM-1PM (EST)
About Naveris, Inc.
Founded in 2017, Naveris is a privately held biotechnology company with facilities in Massachusetts and North Carolina. The company’s mission is to improve outcomes for the millions of people at risk of developing viral cancers through novel molecular diagnostics that enable earlier cancer detection. Naveris’ clinical laboratory is certified for high complexity testing under CLIA, and is accredited by the College of American Pathologists and the New York State Department of Health Wadsworth Center. For more information, please visit www.naveris.com or email contact@naveris.com.
About ASTRO
The American Society for Radiation Oncology (ASTRO) is the largest radiation oncology society in the world. The ASTRO Annual Meeting, the leading scientific meeting in radiation oncology, provides the most up-to-date information on multidisciplinary therapies, clinical research, treatment strategies, supportive care, scientific breakthroughs, and toxicity mitigation for the entire head and neck cancer community.
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