Mayo Clinic has joined forces with molecular diagnostics provider Naveris to begin the DART 2.0 prospective clinical study to assess the latter’s blood test, NavDx.
The trial will assess the potential of NavDx, a blood test for tumour tissue-modified viral-human papillomavirus DNA, to enhance treatment selection in patients with HPV-driven head and neck cancer.
NavDx analyses tumour-derived viral DNA in patients’ blood samples to provide non-invasively tracking of molecular residual disease and recurrence.
Naveris chief medical officer Barry Berger said: “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.”
Data from an earlier phase III MC1675 DART clinical study showed a molecular residual disease, which was detected by NavDx, is a major risk factor for cancer relapse in head and neck cancer patients.
NavDx will allow physicians to select the treatment options suitable for each individual patient, thereby enhancing patient outcomes.
Naveris founder and CEO Piyush Gupta said: “This clinical trial represents a significant step forward in personalised medicine for head and neck cancer patients.
“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.”
In September last year, Naveris raised $33.4m in Series A financing, bringing its total investment to $51m to boost the commercialisation of the NavDx blood test.