Mayo Clinic, Naveris collaborate to evaluate HPV DNA test in clinical trial

Head Neck Social

Waltham, MA-based Naveris on Wednesday announced the launch of the DART 2.0 prospective clinical trial by Mayo Clinic to evaluate the firm’s NavDx blood test for tumor tissue modified viral-HPV DNA.

The test is being developed with the aim of aiding treatment selection for patients with HPV-driven head and neck cancer. According to Naveris, the test provides a noninvasive method for monitoring molecular residual disease (MRD) and recurrence by analyzing tumor-derived viral DNA in patients' blood samples.

“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,” Dr. Barry Berger, chief medical officer of Naveris, said in a statement.

DART 2.0 builds on the results of the previously reported phase III MC1675 DART clinical trial, in which NavDx-detected MRD was a significant risk factor for cancer recurrence in patients with head and neck cancer. The presence of MRD, post-operatively and at three months post-treatment, was strongly associated with shorter progression-free survival, according to Naveris. The MC1675 trial results were presented at the ASTRO 2022 annual meeting last October.

Naveris’ 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. Last September, the company said it had raised $33.4 million to commercialize NavDx.

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