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COMPANY:
Naveris

i
Other names: Naveris | NAVERIS | Naveris Inc. | Naveris Inc
Related tests:
Evidence

News

13d
Naveris to present new data highlighting clinical utility of the NavDx® Test at the 2024 ASCO Annual Meeting (Naveris Press Release)
"Naveris, Inc...announced new data to be presented at The American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, IL from May 31 – June 2, 2024. These presentations underscore Naveris’ continued innovation with the NavDx test, the first and only clinically validated circulating Tumor Tissue Modified Viral (TTMV®)-HPV DNA blood test aiding in the detection and management of HPV-driven cancers."
Clinical data
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NavDx®
2ms
Naveris Announces Launch of Phase II Clinical Study in MRD+ Head and Neck Cancer (Businesswire)
"Naveris, Inc...announced the launch of a Phase II clinical study in minimal residual disease positive (MRD+) HPV-driven head and neck cancer. The study will be led by Memorial Sloan Kettering Cancer Center (MSKCC), a top cancer treatment and research institution. The primary objective of this multicenter randomized study is to evaluate the efficacy of HB-200, a novel intervention, for patients with HPV16+ head and neck squamous cell cancer (HNSCC) with molecular relapse, defined as the presence of circulating Tumor Tissue Modified Viral (TTMV)-HPV DNA without clinical or radiographic evidence of recurrence following definitive treatment."
Trial status
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NavDx®
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HB-200
3ms
Naveris awarded ADLT status by CMS for the NavDx® Test (Naveris Press Release)
"Naveris, Inc...announced that the Centers for Medicare & Medicaid Services (CMS) has granted Advanced Diagnostic Laboratory Test (ADLT) status for NavDx, the Tumor Tissue Modified Viral (TTMV®)-HPV DNA blood test that aids in the detection of HPV-driven cancer."
Medicare • Reimbursement
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NavDx®
3ms
Naveris announces new data at EUROGIN International Multidisciplinary HPV Congress 2024 (Naveris Press Release)
"Naveris, Inc...announced new data at EUROGIN International Multidisciplinary HPV Congress 2024, taking place in Stockholm on March 13-16...Data supporting the clinical validity and utility of NavDx have been published in nearly 20 peer-reviewed publications, leading to recent positive Medicare and commercial insurance coverage policies."
Clinical data
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NavDx®
3ms
Naveris unveils NAVigate-HPV: A groundbreaking registry to advance HPV-driven cancer diagnosis and treatment (Naveris Press Release)
"Naveris, Inc...announced the launch of the NAVigate-HPV Registry. This innovative initiative will refine and expand the applications of the NavDx® test, the first and only clinically validated circulating Tumor Tissue Modified Viral (TTMV®)-HPV DNA blood test."
Launch
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NavDx®
4ms
Naveris Announces New Data at ASTRO Multidisciplinary Head and Neck Cancers Symposium 2024 (Businesswire)
"Naveris, Inc...announced new data to be presented at The American Society for Radiation Oncology (ASTRO) Multidisciplinary Head and Neck Cancers Symposium (MHNCS) in Phoenix, AZ from February 29 – March 2, 2024....The test provides a non-invasive and precise method for identifying HPV-driven cancers before there is clinical or radiographical evidence of disease. Data supporting the clinical validity and utility of NavDx have been published in nearly 20 peer-reviewed publications."
Clinical data
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NavDx®
4ms
Naveris Announces Commercial Payor Coverage for NavDx Test from Highmark, Inc. (Businesswire)
"Naveris, Inc...today announced that Highmark Inc. (Highmark), an independent licensee of the Blue Cross Blue Shield Association, now offers coverage for NavDx, Naveris’ proprietary flagship blood test for Tumor Tissue Modified Viral (TTMV)-HPV DNA...NavDx is the first and only clinically validated circulating TTMV-HPV DNA blood test. It provides a non-invasive and precise method for identifying HPV-driven cancers before there is clinical or radiographical evidence of disease....'Receiving coverage from a payor that serves millions of patients is a meaningful step forward as we work to further expand access to NavDx.'"
Medicare • Commercial • Reimbursement
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NavDx®
6ms
Naveris receives Medicare coverage for NavDx® Test (Naveris Press Release)
"Naveris, Inc...announced that Palmetto GBA, the Medicare Administrative Contractor that administers the Molecular Diagnostics Services program (MolDX®), established Medicare coverage for NavDx®, Naveris’ proprietary flagship blood test for Tumor Tissue Modified Viral (TTMV®)-HPV DNA. NavDx is the first and only clinically validated circulating TTMV-HPV DNA blood test. NavDx provides a non-invasive and precise method for monitoring minimal residual disease (MRD) in HPV-driven cancers before there is clinical or radiographical evidence of recurrence."
Medicare • Reimbursement
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NavDx®
8ms
Naveris announces two peer-review publications validating NavDx® performance in daily clinical practice (Businesswire)
"Naveris, Inc...announced the publication of two new peer-review studies in the journals Clinical Cancer Research (CCR) and JAMA Otolaryngology-Head & Neck Surgery (JAMA Head & Neck), which highlight the clinical utility of the company’s tumor tissue modified viral (TTMV®) DNA platform and add to a growing library of data supporting use of the company’s NavDx® blood test."
Clinical data • Retrospective data • Observational data
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NavDx®
9ms
Naveris announces new data featuring NavDx® in oral highlight and poster presentations at upcoming ASTRO and AAO-HNSF 2023 meetings (Businesswire)
"Naveris, Inc...announced that the company will be attending The American Academy of Otolaryngology-Head and Neck Surgery (AAO-HNSF) 2023 Annual Meeting in Nashville, Tenn., from September 30-October 4 and The American Society for Radiation Oncology (ASTRO) 2023 Annual Meeting in San Diego, Calif., from October 1-4...Naveris will be exhibiting at both meetings, providing the latest information on NavDx®, Naveris’ proprietary flagship blood test for tumor tissue modified viral (TTMV®)-HPV DNA."
Clinical data • P2 data
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NavDx®
1year
Mayo Clinic Collaborates with Naveris to Advance Precision Medicine in HPV-driven Head and Neck Cancer with NavDx in DART 2.0 Clinical Trial (Businesswire)
"Naveris, Inc...announced the launch of the DART 2.0 prospective clinical trial (NCT05541016) by Mayo Clinic. The DART 2.0 trial will evaluate the ability of NavDx, Naveris’ flagship blood test for tumor tissue modified viral (TTMV)-HPV DNA, to improve treatment selection in patients with HPV-driven head and neck cancer. NavDx provides a non-invasive and precise method for monitoring molecular residual disease (MRD) and recurrence by analyzing tumor-derived viral DNA in patients' blood samples."
Trial status • Licensing / partnership • New trial
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NavDx®
over1year
Naveris collaborators present award-winning abstract at ASTRO 2022 on potential of NavDx to inform treatment strategies in HPV-driven cancers (Businesswire)
"Naveris, Inc...announced that the company and the principle investigator at Mayo Clinic will present its award-winning abstract at the American Society for Radiation Oncology (ASTRO) Annual Meeting held October 23-26, 2022. This presentation describes significant new data supporting the clinical value of NavDx®, the first and only clinically validated circulating tumor-tissue-modified HPV (TTMV®) DNA blood test, as a non-invasive blood test to assess the risk of disease recurrence after treatment in patients with human papilloma virus (HPV)-driven head and neck cancer."
P3 data
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NavDx®
over1year
Naveris, Inc. Raises $51 Million to Advance Commercialization of NavDx (Businesswire)
"Naveris, Inc...announced a $33.4 million expansion of its Series A financing, bringing the total investment in Naveris to $51 million. The financing was led by Gurnet Point Capital, joined by TechU Ventures and BrightEdge, the impact and venture capital arm of the American Cancer Society."
Financing
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NavDx®
2years
Naveris Announces Abstract Accepted for Presentation at the 2022 American Society for Clinical Oncology (ASCO) Annual Meeting (Businesswire)
"Naveris, Inc. announces the presentation of an abstract related to its flagship diagnostic test for TTMV-HPV DNA (NavDx) at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting taking place from June 3 through June 7, 2022 in Chicago and virtually. Results of TTMV-HPV DNA testing in the NRG-HN002 phase II clinical trial for patients with p16-positive oropharynx cancer treated with intensity-modulated radiation therapy (IMRT), with or without cisplatin chemotherapy, will be shared in the presentation."
P2 data
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NavDx®
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cisplatin
over2years
Naveris’ head and neck cancer recurrence detection study selected for presentation at ASTRO 2022 Plenary Session (Businesswire)
"Naveris, Inc...announced the presentation of significant new data at the plenary session of the ASTRO 2022 Multidisciplinary Head and Neck Cancers Symposium supporting the clinical value of its flagship diagnostic test, NavDx®...A positive NavDx test, which measures tumor tissue modified viral HPV DNA ('TTMV-HPV DNA'), was the first indication of recurrence in 72% of these patients, previously considered to be disease-free, in which imaging and/or biopsy subsequent to the positive NavDx test confirmed the presence of recurrence."
Real-world evidence
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NavDx®
over2years
Sprinter Health and Naveris partner to expand access to NavDx® cancer blood test (Businesswire)
"Sprinter Health…announced a collaboration with Naveris, a molecular diagnostics company dedicated to improving patient care through early detection of virus-related cancers…The partnership will improve the detection, treatment, and clinical management of HPV-driven cancers, such as head and neck cancers, by augmenting the convenience of Naveris’ lead product, NavDx®, which requires regular blood draws."
Licensing / partnership
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NavDx®