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    TEST:
    NavDx®

    Company:
    Naveris
    Type:
    Laboratory Developed Test
    Details
    Evidence

    News

    13d
    A Study Comparing Two Immunotherapy Options for Human Papillomavirus Positive HPV-Positive Head and Neck Cancer After Treatment (clinicaltrials.gov)
    P2, N=68, Not yet recruiting, University of Chicago | Initiation date: Jan 2026 --> Dec 2026
    Trial initiation date • Minimal residual disease
    |
    PD-L1 (Programmed death ligand 1)
    |
    PD-L1 IHC 22C3 pharmDx • NavDx®
    |
    Libtayo (cemiplimab-rwlc) • fianlimab (REGN3767)
    2ms
    A Study of HB-202/HB-201 in People With Human Papilloma Virus 16-Positive Head and Neck Squamous Cell Cancer (HPV 16+ HNSCC) (clinicaltrials.gov)
    P1, N=7, Active, not recruiting, Memorial Sloan Kettering Cancer Center | Recruiting --> Active, not recruiting | N=10 --> 7
    Enrollment closed • Enrollment change
    |
    NavDx®
    |
    eseba-vec (HB-200) • HB-201
    4ms
    De-Escalated Adjuvant and Definitive Radiation Therapy Informed by DART 2.0 ctHPV-DNA (clinicaltrials.gov)
    P2, N=455, Recruiting, Mayo Clinic | N=320 --> 455
    Enrollment change
    |
    NavDx®
    |
    cisplatin • docetaxel
    4ms
    A Study on Using Cell-Free Tumor DNA (ctDNA) Testing to Decide When to StartRoutine Treatment in People With Human Papilloma Virus (HPV)- Associated Oropharynx Cancer (OPC) (clinicaltrials.gov)
    P2, N=30, Recruiting, Memorial Sloan Kettering Cancer Center | Trial completion date: Mar 2026 --> Mar 2027 | Trial primary completion date: Mar 2026 --> Mar 2027
    Trial completion date • Trial primary completion date • Minimal residual disease • Circulating tumor DNA
    |
    NavDx®
    |
    cisplatin • carboplatin
    6ms
    Prospective Trial Evaluating Post-operative Human Papilloma Virus Circulating Tumor DNA Guided Adjuvant Therapy for Human Papilloma Virus-related Oropharyngeal Carcinoma (PATH study): HPV ctDNA Guided Adjuvant therapy in OPC. (PubMed, Int J Radiat Oncol Biol Phys)
    Deferring adjuvant radiotherapy based on HPV ctDNA using NavDx TTMV-HPV DNA testing resulted in a high rate of disease recurrence.
    Journal • Circulating tumor DNA
    |
    NavDx®
    6ms
    Circulating Human Papilloma Virus (HPV) DNA for the Screening and Surveillance of Gynecologic Cancers (clinicaltrials.gov)
    P=N/A, N=100, Recruiting, Northwell Health | Trial completion date: Aug 2024 --> Aug 2026 | Trial primary completion date: Aug 2024 --> Aug 2026
    Trial completion date • Trial primary completion date
    |
    NavDx®
    6ms
    A Study Using Human Papillomavirus (HPV) DNA Testing to Detect HPV-Related Oropharyngeal Cancer (OPC) (clinicaltrials.gov)
    P=N/A, N=9, Active, not recruiting, Memorial Sloan Kettering Cancer Center | Recruiting --> Active, not recruiting | N=600 --> 9
    Enrollment closed • Enrollment change
    |
    NavDx®
    11ms
    Analytical Validation of NavDx+Gyn, a cfDNA-Based Fragmentomic Profiling Assay for HPV-Driven Gynecologic Cancers. (PubMed, Diagnostics (Basel))
    Regression analysis revealed a high degree of correlation between expected and effective concentrations, demonstrating excellent linearity (R2 > 0.99) across a broad range of analyte concentrations. These results demonstrate that NavDx+Gyn accurately and reproducibly detects fourteen types of high-risk HPV, which aids in the diagnosis and surveillance of the vast majority of HPV-driven gynecologic cancers.
    Journal
    |
    NavDx®
    12ms
    Circulating tumor HPV DNA, antibodies to HPV16 early proteins, and oral HPV16 DNA as biomarkers for HPV-related oropharyngeal cancer screening. (PubMed, Cancer Biomark)
    The 954 subjects with results for all three biomarkers were included in the analysis. The prevalence was 4.9% for oral HPV16 DNA, 0.7% for HPV16 E antibodies, and 0.5% for TTMV-HPV DNA.ConclusionsThe low prevalence of all three biomarkers shows their potential to identify high-risk individuals eligible for further clinical HPV-related cancer screening.
    Journal
    |
    NavDx®
    1year
    A Study on Using Cell-Free Tumor DNA (ctDNA) Testing to Decide When to StartRoutine Treatment in People With Human Papilloma Virus (HPV)- Associated Oropharynx Cancer (OPC) (clinicaltrials.gov)
    P2, N=30, Recruiting, Memorial Sloan Kettering Cancer Center | Trial completion date: Mar 2025 --> Mar 2026 | Trial primary completion date: Mar 2025 --> Mar 2026
    Trial completion date • Trial primary completion date • Minimal residual disease • Circulating tumor DNA
    |
    NavDx®
    |
    cisplatin • carboplatin
    1year
    Highly-multiplex detection of plasma cell-free human papillomavirus-16 DNA in oropharyngeal carcinoma. (PubMed, J Clin Virol)
    This assay is specific for plasma cfHPVDNA detection and prognostic for recurrence. Sub-genomic sensitivity was in close agreement with in silico simulations. The format might be more accessible than dPCR or NGS for longitudinal testing.
    Journal
    |
    NavDx®
    1year
    Naveris Announces Expansion of the NavDx Test in Anal Cancer Molecular Residual Disease Surveillance (Businesswire)
    "Naveris, Inc...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 provides a non-invasive and precise method that can detect MRD before there is clinical or radiographic evidence of cancer recurrence...'With an impressive per-test positive predictive value (PPV) of 98% and a negative predictive value (NPV) of 95%, the NavDx test demonstrates exceptional clinical value in detecting and ruling out disease recurrence in ASCC patients.'....This new data further reinforces the clinical value of TTMV-HPV DNA testing in HPV-positive cancers, as supported by more than 30 peer reviewed publications validating use of the NavDx test in head and neck cancers."
    NavDx®