Mayo Clinic Collaborates with Naveris to Advance Precision Medicine in HPV-driven Head and Neck Cancer with NavDx in DART 2.0 Clinical Trial

WALTHAM, Mass.--(BUSINESS WIRE)--Naveris, Inc., a leader in molecular diagnostics for viral cancers, today announced the launch of the DART 2.0 prospective clinical trial (NCT05541016) by Mayo Clinic.

The DART 2.0 trial will evaluate the ability of NavDx, Naveris’ flagship blood test for tumor tissue modified viral (TTMV)-HPV DNA, to improve treatment selection in patients with HPV-driven head and neck cancer. NavDx provides a non-invasive and precise method for monitoring molecular residual disease (MRD) and recurrence by analyzing tumor-derived viral DNA in patients' blood samples.

Barry M. Berger MD, Chief Medical Officer of Naveris, added, “This trial will build upon the validation of NavDx as a valuable tool for assessing the risk of post-treatment cancer recurrence in these patients, enabling earlier detection of recurrence and application of therapeutic interventions.”

Head and neck cancer is a significant health concern worldwide, with HPV-driven head and neck cancer being the fastest growing type of this cancer. NavDx has the potential to improve outcomes for patients by enabling physicians to select the best treatment options for each individual patient, with the goal of improving patient outcomes while reducing the side-effects and morbidity of medical treatment.

"This clinical trial represents a significant step forward in personalized medicine for head and neck cancer patients," said Piyush B. Gupta PhD, Founder and CEO of Naveris. "NavDx has the potential to be a game-changer in treatment selection, allowing physicians to tailor treatment plans to individual patients based on their unique biomarker profiles."

DART 2.0 builds upon the results of the previously reported phase III MC1675 DART clinical trial, where NavDx-detected molecular residual disease (MRD) was a significant risk factor for cancer recurrence in patients with head and neck cancer. The presence of MRD, both post-operatively and at 3 months post-treatment, was strongly associated with shorter progression-free survival. The MC1675 trial results were presented at the ASTRO 2022 annual meeting.

For more information on NavDx and the DART 2.0 clinical trial please visit ClinicalTrials.gov, NCI and Naveris.

About Naveris:

Naveris is a privately held commercial stage biotechnology company with facilities in Massachusetts and North Carolina. Since its inception in 2017, Naveris has been committed to improving outcomes for the millions of people at risk of developing viral cancers through novel molecular diagnostics that enable earlier cancer detection. The company's high-complexity testing clinical laboratory is accredited by the College of American Pathologists and the New York State Department of Health Wadsworth Center, and is certified under CLIA. For more information on Naveris and its clinical impact, please visit www.naveris.com or email [e-mail].