Coverage from Palmetto GBA’s MolDX® Program Expands Access to Advanced Recurrence Surveillance Testing for HPV-Driven Anal Cancer
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 the company’s NavDx® test to be used in the surveillance of patients with previously treated anal squamous cell carcinoma (ASCC). This decision makes NavDx the first and only test to be covered by Medicare in ASCC for Molecular Residual Disease (MRD) testing, significantly expanding access to more personalized disease management for patients. MRD testing with the NavDx test has been a covered benefit for Medicare beneficiaries with a history of human papillomavirus (HPV) induced head and neck cancer since August 2023.
“The MolDX program’s rigor in evaluating NavDx confirms its analytical performance and clinical utility for use in the setting of ASCC MRD,” noted James McNally, Chief Executive Officer of Naveris. “This decision furthers Naveris’ mission to improve outcomes for those with HPV-driven cancers and builds on our significant momentum of expanding patient access to NavDx through both Medicare and commercial payers.”
New cases of ASCC arise in nearly 11,000 people in the United States each year, with approximately 90% of cases driven by HPV infection. The incidence of ASCC has been steadily rising, driven in part by demographics and increased prevalence among immunocompromised populations, including people living with HIV. ASCC recurrence is observed in up to 30% of patients following treatment and current surveillance methods are often limited by inconclusive results or a lack of access to monitoring resources, especially for underserved populations. These challenges underscore the urgent need for more accurate and accessible testing that enables earlier detection of MRD.
The NavDx test is a clinically validated, proprietary blood test that detects Tumor Tissue Modified Viral (TTMV®)-HPV DNA to assess MRD. This positive coverage determination follows the publication of a multi-institutional study in Cancers demonstrating that NavDx detects ASCC recurrence with high sensitivity and specificity and demonstrating a per-test positive predictive value (PPV) of 98% and a negative predictive value (NPV) of 95%.1
“Medicare coverage of NavDx for recurrence surveillance in ASCC patients represents a major advancement for patients with HPV-driven cancers,” said Barry M. Berger, MD, Chief Medical Officer of Naveris. “By identifying molecular residual disease earlier and more precisely, the NavDx test allows clinicians to intervene sooner, potentially improving outcomes for patients with disease recurrence while also offering peace-of-mind to patients who remain disease free.”
The pivotal study also revealed that 44% of patients had one or more clinically ambiguous findings during the course of their ASCC surveillance. Coincident NavDx testing resolved 94% of such cases to “with recurrence” or “recurrence free” with a single blood test, demonstrating additional clinical utility when compared to traditional recurrence surveillance methods.
“This milestone reflects the groundbreaking science driving the NavDx test and brings us another step closer to redefining how cancer is detected and managed through noninvasive blood-based testing,” said Piyush B. Gupta, PhD, Founder, Executive Chairman, and Chief Scientific and Innovation Officer of Naveris. “It also powerfully highlights the broad platform potential of our TTMV technology—spanning multiple viral-driven cancers and supporting patients across their entire diagnosis and treatment journey.”
1- |
Kabarriti, R.; Lloyd, S.; Jabalee, J.; Del Vecchio Fitz, C.; Tao, R.; Slater, T.; Jacobs, C.; Inocencio, S.; Rutenberg, M.; Matthiesen, C.; et al. Evaluating Tumor Tissue Modified Viral (TTMV)-HPV DNA for the Early Detection of Anal Squamous Cell Carcinoma Recurrence. Cancers 2025, 17, 174. https://doi.org/10.3390/cancers17020174 |
About Naveris
Naveris is a privately held, commercial-stage precision oncology diagnostics company with laboratories in Massachusetts and North Carolina. The Company develops novel molecular diagnostics to enable earlier detection and improved outcomes for patients across a broad range of cancers, with leadership in viral-induced malignancies. The Company’s flagship NavDx test has been ordered more than 100,000 times to support the care of over 40,000 cancer patients across all 50 U.S. states. Naveris’ high-complexity laboratories 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, please visit www.naveris.com and www.NavDx.com.
View source version on businesswire.com: https://www.businesswire.com/news/home/20251117164764/en/
This decision makes NavDx the first and only test to be covered by Medicare in ASCC for Molecular Residual Disease (MRD) testing, significantly expanding access to more personalized disease management for patients.
