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    TEST:
    NavDx®

    Company:
    Naveris
    Type:
    Laboratory Developed Test
    Details
    Evidence

    News

    1d
    Omission of Postoperative Radiation in HPV-Associated Oropharyngeal Cancer Using ctHPVDNA Surveillance (OPERATION) (clinicaltrials.gov)
    P2, N=36, Not yet recruiting, Medical University of South Carolina
    New P2 trial
    |
    NavDx®
    1m
    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
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    PD-L1 (Programmed death ligand 1)
    |
    PD-L1 IHC 22C3 pharmDx • NavDx®
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    Libtayo (cemiplimab-rwlc) • fianlimab (REGN3767)
    3ms
    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
    5ms
    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
    5ms
    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®
    7ms
    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®
    7ms
    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®
    12ms
    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®
    1year
    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
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    NavDx®