Naveris Receives Medicare Coverage for NavDx® Test

Proprietary blood test now covered for all Medicare beneficiaries with HPV-driven head and neck cancer

WALTHAM, Mass.--(BUSINESS WIRE)--Naveris, Inc., the leader in precision oncology diagnostics for viral-induced cancers, today announced that Palmetto GBA, the Medicare Administrative Contractor that administers the Molecular Diagnostics Services program (MolDX®), established Medicare coverage for NavDx®, Naveris’ proprietary flagship blood test for Tumor Tissue Modified Viral (TTMV®)-HPV DNA. NavDx is the first and only clinically validated circulating TTMV-HPV DNA blood test. NavDx provides a non-invasive and precise method for monitoring minimal residual disease (MRD) in HPV-driven cancers before there is clinical or radiographical evidence of recurrence.

“Coverage through the Palmetto MolDX process, with its high clinical bar for approval, is meaningful for patients and their physicians,” said Barry M. Berger, MD, Chief Medical Officer of Naveris. “NavDx enables protocols to optimize the management of HPV-driven cancer throughout the care continuum, from diagnosis and assessment of treatment response to identifying post-treatment MRD and local and distant recurrence.”

"Attaining Medicare coverage marks a pivotal moment not only for Naveris but more importantly for the patients and clinicians we support," said Piyush B. Gupta, PhD, Founder, Executive Chairman, and Chief Science and Technology Officer of Naveris. “NavDx, powered by Naveris’ TTMV technology platform, enables earlier disease detection and positions clinicians to make informed decisions when the potential for cure is at its greatest.”

Following this decision, NavDx is the first MRD test covered for Medicare beneficiaries with HPV-driven oropharyngeal (head and neck) cancer who are in surveillance for recurrence, starting three months after completion of any curative intent therapy.

“This decision underscores the powerful clinical utility of Naveris’ TTMV platform and comes at a time of significant company momentum,” said James McNally, Chief Executive Officer of Naveris. “Medicare coverage and future reimbursement will increase patient access to NavDx and we look forward to continued access expansion through commercial channels in the near future.”

About Naveris

Naveris is a privately held, commercial stage, precision oncology diagnostics company with facilities in Massachusetts and North Carolina. Naveris is dedicated to improving outcomes for the millions of people at risk of developing viral-induced cancers by developing 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).