Wednesday saw the launch of the DART 2.0 prospective clinical trial by Mayo Clinic, which will evaluate Waltham, Massachusetts-based Naveris’s NavDx blood test for tumor tissue modified viral-HPV DNA.
The test is being created with the intention of assisting patients with head and neck cancer caused by HPV in making treatment decisions. By examining tumor-derived viral DNA in patient blood samples, Naveris claims that the test offers a noninvasive method for monitoring molecular residual disease (MRD) and recurrence.
“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,” Naveris’ chief medical officer, Dr. Barry Berger, stated in a statement.
The phase III MC1675 DART clinical trial’s findings that NavDx-detected MRD was a significant risk factor for cancer recurrence in patients with head and neck cancer served as the foundation for DART 2.0. Naveris found a strong correlation between the presence of MRD post-operatively and three months after treatment and a reduction in progression-free survival. At the ASTRO 2022 annual meeting in October of last year, the MC1675 trial results were announced.
The College of American Pathologists and the New York State Department of Health Wadsworth Center have both granted accreditation to Naveris’ high-complexity testing clinical laboratory, which is also CLIA-certified. In September of last year, the business announced that it had raised $33.4 million to market NavDx.
