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NavDx Test Expands Availability for Enhanced Surveillance in HPV+ Anal Cancer Patients

NextEdge Admin

13 Jan 2025

2 min 34 sec

Molecular Residual Disease,squamous cell carcinoma,precision oncology,HPV DNA blood test

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

This expansion follows the publication of clinical validity and utility data in Cancers, demonstrating the NavDx test’s accuracy in detecting MRD in a multi-center, real-world cohort of ASCC patients. Dr. Barry M. Berger, Chief Medical Officer of Naveris, highlighted its exceptional clinical value, citing a 98% positive predictive value (PPV) and 95% negative predictive value (NPV). This allows physicians to assess residual disease with confidence, enabling timely and appropriate treatment decisions.

NavDx’s success in HPV-positive head and neck cancers, validated by over 30 peer-reviewed publications, underscores its clinical significance in HPV-driven malignancies. Its application in anal cancer surveillance enhances access to high-quality, non-invasive monitoring, complementing traditional institutional methods.

The expansion also aligns with Naveris’ commitment to health equity, addressing disparities in care for populations disproportionately affected by anal cancer, including individuals living with HIV and those of lower socioeconomic status. Alice L. Pomponio, Managing Director of the American Cancer Society’s BrightEdge, emphasized NavDx’s role in removing barriers to care and advancing early cancer detection.

By integrating NavDx into routine surveillance, Naveris is advancing precision medicine and improving outcomes for HPV-related anal cancer patients.