The Centers for Medicare & Medicaid Services (CMS) has designated Naveris’ Tumor Tissue Modified Viral (TTMV)-HPV DNA blood test that aids in the detection of HPV-driven cancer, NavDx, as an advanced diagnostic laboratory test (ADLT).
Obtaining ADLT status confirms that NavDx meets the highly selective criteria established under the Protecting Access to Medicare Act of 2014 (PAMA), the company says. The NavDx test received Medicare coverage in late 2023 for assessing molecular residual disease (MRD) in patients with a history of HPV-driven head and neck cancer.
“We commend CMS’s 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,” says Piyush B. Gupta, PhD, founder, executive chairman, and chief science and technology officer of Naveris. “This ADLT designation, along with Medicare coverage for NavDx, expands beneficiary access to earlier detection and treatment of cancer, improving patient care and outcomes.”
Further reading: New Initiative Aims to Advance HPV-Driven Cancer Test
About the NavDX Test
NavDx’s clinically validated circulating TTMV-HPV DNA blood test provides a non-invasive and precise method for detecting HPV-driven cancers before there is clinical or radiographical evidence of disease. Data supporting the clinical validity and utility of NavDx has been published in nearly 20 peer-reviewed publications. Approval of new ADLT status for NavDx as described by CPT code 0356U is effective as of April 1, 2024, according to the company.
“Receiving ADLT designation for the NavDx test is an exciting next step for Naveris and confirms the unique clinical information provided by NavDx and our TTMV platform,” says James McNally, chief executive officer of Naveris. “This is a major milestone in the growth of our company and demonstrates our commitment to improving patient access to precision medicine tools for HPV-related cancer surveillance.”
