Naveris, Inc., the leader in precision oncology diagnostics for viral-induced cancers, today announced the expanded commercial availability of the NavDx test for Molecular Residual Disease (MRD) detection in anal squamous cell carcinoma (ASCC) patients. NavDx, Naveris’ proprietary flagship blood test, is the first and only clinically validated circulating tumor TTMV®-HPV DNA blood test that offers a non-invasive and precise method to detect MRD before clinical or radiographic signs of cancer recurrence appear.

The commercial expansion coincides with the publication of clinical validity and utility data in the journal Cancers that demonstrates the NavDx test’s ability to accurately and reliably detect MRD in HPV-positive anal cancer patients in a multi-center, real-world cohort.

Dr. Barry M. Berger, Chief Medical Officer of Naveris, commented: “With an impressive per-test positive predictive value (PPV) of 98% and a negative predictive value (NPV) of 95%, the NavDx test offers significant clinical value in detecting and ruling out disease recurrence in ASCC patients. This enables physicians to assess whether a patient has residual disease and to implement the most appropriate course of care promptly and accurately, avoiding unnecessary delays. The expanded use of NavDx is a crucial step forward in advancing precision medicine and improving the overall management of HPV-related anal cancer.”

This new data further reinforces the clinical value of TTMV-HPV DNA testing in HPV-positive cancers, as supported by over 30 peer-reviewed publications validating the use of the NavDx test in head and neck cancers.

The expansion of the NavDx test for HPV-positive anal cancer patients also reflects Naveris’ commitment to increasing access to high-quality care. As a blood test, the NavDx test offers a simpler, non-invasive, and more accessible complement to traditional institution-based surveillance methods and is expected to increase healthcare access for individuals who face challenges in receiving timely and effective cancer care.

“Certain populations, notably those living with HIV and from lower socioeconomic backgrounds, are disproportionately affected by anal cancer and often face barriers to accessing care under current recurrence surveillance protocols,” noted Alice L. Pomponio, Managing Director of the American Cancer Society’s BrightEdge impact investing arm and a Naveris Board Observer. “By bringing the NavDx test to clinics for anal cancer MRD testing, Naveris addresses an urgent need for early cancer detection solutions and promotes health equity for individuals facing barriers to care. Through innovation, we can improve clinical care for underserved populations, fulfilling our shared mission to drive impact investing.”