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    TEST:
    NavDx®

    Company:
    Naveris
    Type:
    Laboratory Developed Test
    Details
    Evidence

    News

    21d
    Circulating Tumor High Risk HPV DNA as the HPV-Specific Test in Oropharyngeal Squamous Cell Carcinoma Patients. (PubMed, Head Neck Pathol)
    The high specificity and PPV of ctHPVDNA indicate that in the setting of a positive result and high clinical suspicion, it may not be necessary for pathologists to test subsequent cytology or tissue specimens that are diagnostic for SCC for p16 or HPV. In the setting of a negative ctHPVDNA result, however, our findings indicate that HPV testing of a pathology specimen must still be performed.
    Retrospective data • Journal
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    NavDx®
    29d
    Omission of Postoperative Radiation in HPV-Associated Oropharyngeal Cancer Using ctHPVDNA Surveillance (OPERATION) (clinicaltrials.gov)
    P2, N=36, Recruiting, Medical University of South Carolina | Not yet recruiting --> Recruiting
    Enrollment open
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    NavDx®
    2ms
    Expanded subtype testing for circulating tumor HPV DNA reliably detects the presence of advanced-stage cervical cancer. (PubMed, Gynecol Oncol)
    TTMV-HPV DNA is a sensitive and specific biomarker for advanced CC, with Scores dynamically corresponding to treatment response, and has the potential to serve an unmet need as a universal biomarker for patients with HPV-related CC.
    Journal
    |
    NavDx®
    2ms
    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®
    4ms
    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)
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    PD-L1 IHC 22C3 pharmDx • NavDx®
    |
    Libtayo (cemiplimab-rwlc) • fianlimab (REGN3767)
    5ms
    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
    8ms
    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
    8ms
    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
    9ms
    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®
    9ms
    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®
    9ms
    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®
    1year
    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
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    NavDx®