NEW YORK – Naveris said Wednesday that Mayo Clinic began a Phase II trial of its circulating tumor DNA blood test, NavDx, to guide treatment for patients with HPV-driven head and neck cancer.
The NavDx test can detect tumor tissue-modified HPV DNA and distinguish it from noncancerous sources of HPV DNA. Waltham, Massachusetts-based Naveris markets it for identification and stratification of patients for adjuvant or follow-on chemotherapy and radiation, and for detection of molecular residual disease following treatment.
Building on results from the previously reported Phase III MC1675 DART trial, the Dart 2.0 trial will evaluate the use of NavDx to select the intensity of treatment for patients with HPV-driven head and neck cancer to optimize the efficacy of treatment while minimizing cancer recurrence and side effects. In the MC1675 DART trial, researchers found that molecular residual disease was a significant risk factor for cancer recurrence and was strongly associated with shorter progression-free survival.
"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 Barry Berger said in a statement.
NavDx was developed by researchers at the University of North Carolina. It uses digital PCR to detect tumor-modified HPV DNA. In a study involving 115 patients by the UNC investigators, the test was 99 percent accurate in identifying patients who would remain cancer-free during the study, with 94 percent sensitivity in identifying early recurrences.
The company is now exploring potential paths for expanding the use of its test in a number of research studies.