NavDx®
Use
NavDx® is a clinically validated circulating tumor‑tissue‑modified HPV (TTMV®) DNA blood test that aids in the detection of HPV‑driven cancers — particularly HPV+ head and neck cancer, and is being expanded to anal squamous cell carcinoma. It quantifies fragments of TTMV‑HPV DNA shed by cancer cells into the blood, helping to detect active disease, assess treatment response, monitor molecular residual disease, and identify recurrences earlier than imaging modalities. The test has high predictive accuracy (≥95% PPV and NPV).
Special Instructions
Not provided.
Limitations
For patients without a pretreatment NavDx blood test, the primary tumor tissue may need to be tested to confirm HPV status. The test is a laboratory‑developed test (LDT) and has not been cleared or approved by the FDA.
Methodology
PCR-based (PCR)
Biomarkers
HPV genotype
OtherTTMV‑HPV DNA
Other
Result Turnaround Time
7 days
Related Documents
For more information, please review the documents below
Specimen
Whole Blood
Volume
10 mL
Minimum Volume
6 mL
Container
Streck tube
Collection Instructions
Collect in Streck tubes; ship ambient same or next day with provided kit.
Storage Instructions
Do not freeze or refrigerate; ship ambient.
