WALTHAM, Mass. (March 21, 2024)– Naveris, Inc., the leader in precision oncology diagnostics for viral-related cancers, today announced that the Centers for Medicare & Medicaid Services (CMS) has granted Advanced Diagnostic Laboratory Test (ADLT) status for NavDx, the Tumor Tissue Modified Viral (TTMV®)-HPV DNA blood test that aids in the detection of HPV-driven cancer.
Obtaining ADLT status confirms that Naveris meets the highly selective criteria established under the Protecting Access to Medicare Act of 2014 (PAMA). Naveris received Medicare coverage for the use of the NavDx test to detect molecular residual disease (MRD) for patients with HPV-driven head and neck cancer in late 2023.
“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,” said Piyush B. Gupta, PhD, Founder, Executive Chairman, and Chief Science and Technology Officer of Naveris. “This ADLT designation is a leap forward in our collective quest to revolutionize patient care and outcomes through earlier detection and treatment of cancer.”
NavDx is the first and only clinically validated circulating TTMV-HPV DNA blood test. It 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.
“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,” said James McNally, Chief Executive Officer of Naveris. “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.”
About Naveris
Naveris is a privately held, commercial stage, precision oncology diagnostics company with facilities in Massachusetts and North Carolina. Since its founding in 2017, Naveris has been committed to improving outcomes for the millions of people at risk of developing viral-induced cancers with novel molecular diagnostics that enable earlier cancer detection. The company operates high-complexity testing clinical laboratories that are accredited by the College of American Pathologists and the New York State Department of Health Wadsworth Center, and are certified under CLIA. For more information on Naveris and the clinical impact of NavDx, please visit www.naveris.com and www.NavDx.com. NavDx has not been cleared or approved by the US Food and Drug Administration (FDA).
Contact
Terri Clevenger
ICR Westwicke Healthcare PR
Tel: 203-682-8297
Terri.Clevenger@westwicke.com
