{"entity":{"id":"navdx","kind":"drug","name":"NavDx","aka":["TTMV-HPV DNA test","NavDx TTMV-HPV DNA"],"tldr":"A blood test that counts HPV DNA shed by HPV-driven throat and anal cancers, used to watch for the cancer coming back; Medicare covers it in both.","summary":"NavDx, made by Naveris and owned by CareDx since 1 July 2026, measures tumour tissue modified viral HPV DNA in plasma. Medicare's MolDX programme covered it from August 2023 for surveillance of HPV-driven oropharyngeal cancer after curative-intent treatment, announced on 30 November 2023, and on 17 November 2025 extended coverage to surveillance after treated anal squamous cell carcinoma. CareDx states that it has a Medicare reimbursement rate of 1,800 dollars as an advanced diagnostic laboratory test and that more than 130,000 tests have been reported. In a study of 543 patients under surveillance for HPV-driven oropharyngeal cancer, the negative predictive value was 99.4% per test (Hanna et al., Clinical Cancer Research 2023).","status":"established","asOf":"2026-11-03","links":[{"label":"NavDx","url":"https://navdx.com/"},{"label":"NavDx physician FAQs","url":"https://navdx.com/physician-faqs/"},{"label":"Naveris: Medicare coverage for NavDx in oropharyngeal cancer (30 November 2023)","url":"https://naveris.com/naveris-receives-medicare-coverage-for-navdx-test/"},{"label":"Naveris: Medicare coverage for NavDx in anal cancer (17 November 2025)","url":"https://naveris.com/naveris-announces-medicare-coverage-of-the-navdx-test-in-anal-cancer-molecular-residual-disease-surveillance/"},{"label":"CareDx completes acquisition of Naveris (1 July 2026)","url":"https://www.caredx.com/newsroom/press-releases/caredx-completes-acquisition-of-naveris-extending-leadership-into-high-growth-specialty-oncology"},{"label":"Hanna et al., negative predictive value of TTMV-HPV DNA (Clinical Cancer Research 2023)","url":"https://doi.org/10.1158/1078-0432.CCR-23-1478"},{"label":"CMS MolDX billing article A58376: minimal residual disease testing for solid tumour cancers","url":"https://www.cms.gov/medicare-coverage-database/view/article.aspx?articleid=58376"}],"tags":["test"],"related":["radar-mrd"],"cancers":["hpv-positive-oropharyngeal-cancer","oropharyngeal-cancer","head-and-neck","anal"],"sections":[],"technologies":["cthpv-dna","mrd-testing","liquid-biopsy"],"targets":[],"drugs":[],"companies":["naveris"],"institutions":[],"pathways":[],"terms":["mrd","ctdna"],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":["What a result means: a rising or newly detectable level after treatment suggests the cancer is returning, often before it shows on imaging; it applies only to cancers caused by HPV.","The start of the covered surveillance window differs between sources: three months after curative therapy in the 2023 coverage release, one day after surgery or seven days after other treatment in the current physician FAQ. No FDA status was found on the pages read."],"brand":"NavDx","modality":"Tumour-naive circulating tumour HPV DNA test (digital droplet PCR)","mechanism":"Quantitative digital droplet PCR counts fragments of tumour tissue modified viral (TTMV) HPV DNA, which dying HPV-driven tumour cells shed into the blood; it identifies the most common high-risk HPV types, including 16, 18, 31, 33 and 35. No tumour sequencing is needed because the virus itself is the marker.","approvals":[],"mechanismSteps":[],"toxicity":[],"access":[{"country":"US","reimbursement":"Medicare (MolDX) covers surveillance of HPV-driven oropharyngeal cancer from three months after curative-intent treatment (announced 30 November 2023) and surveillance after treated anal squamous cell carcinoma (17 November 2025)","source":"https://naveris.com/naveris-announces-medicare-coverage-of-the-navdx-test-in-anal-cancer-molecular-residual-disease-surveillance/","asOf":"2026-11-03"}],"regulatoryEvents":[]},"route":"/drugs/navdx/","neighbours":{"drug":[{"id":"radar-mrd","kind":"drug","name":"RaDaR ST","route":"/drugs/radar-mrd/"}],"cancer":[{"id":"anal","kind":"cancer","name":"Anal cancer (squamous cell carcinoma)","route":"/cancers/anal/"},{"id":"head-and-neck","kind":"cancer","name":"Head and neck squamous cell carcinoma","route":"/cancers/head-and-neck/"},{"id":"hpv-positive-oropharyngeal-cancer","kind":"cancer","name":"HPV-positive oropharyngeal cancer","route":"/cancers/hpv-positive-oropharyngeal-cancer/"},{"id":"oropharyngeal-cancer","kind":"cancer","name":"Oropharyngeal cancer (tonsil and base of tongue)","route":"/cancers/oropharyngeal-cancer/"}],"technology":[{"id":"cthpv-dna","kind":"technology","name":"Circulating tumour HPV DNA (ctHPV-DNA)","route":"/technologies/cthpv-dna/"},{"id":"liquid-biopsy","kind":"technology","name":"Liquid biopsy (ctDNA)","route":"/technologies/liquid-biopsy/"},{"id":"mrd-testing","kind":"technology","name":"MRD / molecular residual disease testing","route":"/technologies/mrd-testing/"}],"company":[{"id":"naveris","kind":"company","name":"Naveris","route":"/companies/naveris/"}],"term":[{"id":"ctdna","kind":"term","name":"Circulating tumour DNA (ctDNA)","route":"/terms/ctdna/"},{"id":"mrd","kind":"term","name":"Minimal / molecular residual disease (MRD)","route":"/terms/mrd/"},{"id":"tumour-informed-assay","kind":"term","name":"Tumour-informed versus tumour-naive ctDNA assays","route":"/terms/tumour-informed-assay/"}],"roadmap":[{"id":"ctdna-tests","kind":"roadmap","name":"ctDNA tests roadmap: from a curiosity in plasma to blood tests that decide treatment","route":"/roadmaps/ctdna-tests/"},{"id":"diagnostics-roadmap","kind":"roadmap","name":"Diagnostics roadmap: stains → gene panels → blood tests that decide treatment","route":"/roadmaps/diagnostics-roadmap/"}],"biomarker":[{"id":"ctdna-mrd-positive","kind":"biomarker","name":"ctDNA MRD positivity (molecular residual disease after curative treatment)","route":"/biomarkers/ctdna-mrd-positive/"}]}}