DURHAM, N.C. — Naveris, Inc., a leader in precision oncology diagnostics for viral-induced cancers, today announced expanded Medicare coverage for its NavDx test through Palmetto GBA’s MolDX program. The test is now covered for surveillance of molecular residual disease (MRD) in patients with previously treated anal squamous cell carcinoma (ASCC), making NavDx the first and only MRD test covered by Medicare for this type of cancer. NavDx has been covered for MRD testing in human papillomavirus (HPV)-induced head and neck cancers 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,” said 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.”
ASCC affects nearly 11,000 people in the United States each year, with approximately 90 percent of cases driven by HPV infection. Recurrence occurs in up to 30 percent of patients after treatment, yet current surveillance methods are often inconclusive or inaccessible, especially among underserved and immunocompromised populations. These challenges highlight the need for more accurate and accessible tools to detect MRD earlier.
The NavDx test is a clinically validated blood test that detects Tumor Tissue Modified Viral (TTMV)-HPV DNA to assess MRD. The expanded Medicare coverage follows the publication of a multi-institutional study in the journal Cancers, which demonstrated the test’s high sensitivity and specificity in detecting ASCC recurrence, with a positive predictive value of 98 percent and a negative predictive value of 95 percent.
“Medicare coverage of NavDx for recurrence surveillance in ASCC patients represents a major advancement for patients with HPV-driven cancers,” said Barry M. Berger, M.D., 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 study also found that 44 percent of ASCC patients experienced clinically ambiguous findings during surveillance. NavDx testing clarified 94 percent of these cases with a single blood test, providing valuable clinical insight beyond traditional 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, Ph.D., 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.”
