Precision oncology diagnostics company Naveris has received Advanced Diagnostic Laboratory Test (ADLT) status from the Centers for Medicare & Medicaid Services (CMS) for its NavDx test.

NavDx is a circulating tumour-tissue–modified HPV (TTMV) DNA blood test developed for the detection of HPV-driven cancer.

The new ADLT status, under CPT code 0356U, will be in effect from 1 April 2024.

Naveris CEO James McNally said: “Receiving the ADLT status marks an exciting next step for Naveris and confirms the unique clinical information provided by the NavDx test and our TTMV platform.

“This is a major milestone in the growth of our company and demonstrates our commitment to working closely with CMS and commercial payers to ensure patient access to precision medicine tools for HPV-related cancer surveillance.”

The clinically validated test offers a non-invasive approach to detect molecular residual disease (MRD) in patients with HPV-driven head and neck cancer, even before clinical symptoms or radiographic evidence emerges.

Naveris said the clinical validity and utility of NavDx are supported by nearly 20 peer-reviewed studies.

Naveris founder, executive chairman, and chief science and technology officer Piyush Gupta said: “We commend CMS for their rigorous approach to diagnostic test coverage and reimbursement, which has been crucial for making life-saving technologies like NavDx broadly accessible to patients suffering from cancer.

“This ADLT designation is a leap forward in our collective quest to revolutionise patient care and outcomes through earlier detection and treatment of cancer.”

In April 2023, Mayo Clinic and Naveris teamed up to begin the DART 2.0 prospective clinical study to assess the blood test, NavDx.