TTMV

Naveris Announces Launch of Phase II Clinical Study in MRD+ Head and Neck Cancer

Retrieved on: 
Wednesday, April 24, 2024
Oncology, Medical Devices, Health, Hospitals, Clinical Trials, Biotechnology, Cancer, HNSCC, MRD, Recurrence, Doctor of Philosophy, Research, MSKCC, DNA, Patient, HPV, Head, Neoplasm, TTMV

Naveris, Inc. , the leader in precision oncology diagnostics for viral-induced cancers, today announced the launch of a Phase II clinical study in minimal residual disease positive (MRD+) HPV-driven head and neck cancer.

Key Points: 
  • Naveris, Inc. , the leader in precision oncology diagnostics for viral-induced cancers, today 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.
  • “This study will propose a novel intervention for patients with MRD+ HPV-driven head and neck cancer and will assess the ability of NavDx to identify MRD in these patients,” said Alan L. Ho, MD, PhD, Head and Neck Oncologist and Cellular Therapist, Memorial Sloan Kettering, and the primary principal investigator for the study.
  • We are grateful to the research team at Memorial Sloan Kettering Cancer Center for their collaboration and we look forward to presenting the results of this study when they are complete.”

CMS Designates the NavDx® Test as an Advanced Diagnostic Laboratory Test (ADLT)

Retrieved on: 
Thursday, March 21, 2024
Oncology, Health, Medical Devices, Infectious Diseases, Health Technology, Genetics, Biotechnology, TTMV, Growth, Disease, Patient, DNA, PAMA, History, Cancer, Doctor of Philosophy, Medicine, MRD, Medicare, CMS

Naveris, Inc. , the leader in precision oncology diagnostics for viral-related cancers, today announced that the Centers for Medicare & Medicaid Services (CMS) has designated NavDx, the Tumor Tissue Modified Viral (TTMV®)-HPV DNA blood test that aids in the detection of HPV-driven cancer, as an Advanced Diagnostic Laboratory Test (ADLT).

Key Points: 
  • Naveris, Inc. , the leader in precision oncology diagnostics for viral-related cancers, today announced that the Centers for Medicare & Medicaid Services (CMS) has designated NavDx, the Tumor Tissue Modified Viral (TTMV®)-HPV DNA blood test that aids in the detection of HPV-driven cancer, as an Advanced Diagnostic Laboratory Test (ADLT).
  • Obtaining ADLT status confirms that NavDx meets the highly selective criteria established under the Protecting Access to Medicare Act of 2014 (PAMA).
  • The NavDx test received Medicare coverage in late 2023 for assessing molecular residual disease (MRD) in patients with a history of HPV-driven head and neck cancer.
  • Approval of new ADLT status for NavDx as described by CPT® code 0356U is effective as of April 1, 2024.

Naveris Announces Commercial Payor Coverage for NavDx® Test from Highmark, Inc.

Retrieved on: 
Thursday, February 22, 2024
Biotechnology, General Health, Health, Oncology, TTMV, Cancer, Medicare, Patient, Disease, Diagnosis, DNA

NavDx is the first and only clinically validated circulating TTMV-HPV DNA blood test.

Key Points: 
  • 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.
  • “This test helps to optimize the management of HPV-driven cancer from diagnosis to post-treatment monitoring to surveilling for molecular residual 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.”

Naveris Receives Medicare Coverage for NavDx® Test

Retrieved on: 
Thursday, November 30, 2023
Oncology, Medical Supplies, Health, Health Technology, Health Insurance, Biotechnology, Palmetto, DNA, Head, TTMV, Patient, MRD, MD, Diagnosis, Medicare, Doctor of Philosophy, Cancer, Recurrence, Physician, Raoul de Navery

Naveris, Inc. , the leader in precision oncology diagnostics for viral-induced cancers, today 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.

Key Points: 
  • Naveris, Inc. , the leader in precision oncology diagnostics for viral-induced cancers, today 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.
  • “This decision underscores the powerful clinical utility of Naveris’ TTMV platform and comes at a time of significant company momentum,” said James McNally, Chief Executive Officer of Naveris.
  • “Medicare coverage and future reimbursement will increase patient access to NavDx and we look forward to continued access expansion through commercial channels in the near future.”

Naveris Announces Two Peer-Review Publications Validating NavDx® Performance in Daily Clinical Practice

Retrieved on: 
Thursday, October 12, 2023
Radiology, Health, Surgery, Oncology, Diagnosis, Neoplasm, TTMV, Physician, Ferrandino, Doctor of Philosophy, Research, Dana–Farber Cancer Institute, MD, DNA, CCR, Recurrence, Disease, Human, JAMA, HPV, Literature, Clinical Cancer Research, MRD, Liquid biopsy, OPSCC, Patient, Vaccine

Negative Predictive Value of Circulating Tumor Tissue Modified Viral (TTMV)-HPV DNA for HPV-driven Oropharyngeal Cancer Surveillance (Hanna, G.J.

Key Points: 
  • Negative Predictive Value of Circulating Tumor Tissue Modified Viral (TTMV)-HPV DNA for HPV-driven Oropharyngeal Cancer Surveillance (Hanna, G.J.
  • ), published in CCR, is a retrospective observational cohort study involving 543 patients who completed therapy for HPV-driven oropharyngeal squamous cell carcinoma (OPSCC).
  • “NavDx has consistently exhibited stellar performance in well over a dozen peer-reviewed studies following thousands of HPV-driven OPSCC patients.
  • “We congratulate these investigators on their outstanding research, and look forward to our ongoing partnerships with the clinical research community to support bringing NavDx testing to more patients.”

Naveris Announces New Data Featuring NavDx® in Oral Highlight and Poster Presentations at Upcoming ASTRO and AAO-HNSF 2023 Meetings

Retrieved on: 
Thursday, September 28, 2023
Biotechnology, Other Health, Health, General Health, Oncology, Other Science, Medical Devices, Research, Hospitals, Science, Clinical Trials, TTMV, Abstract, DNA, Session, San Diego Convention Center, Head, ASTRO, OPSCC, Booth, Cancer, American Academy of Otolaryngology–Head and Neck Surgery, American Academy, Radiation therapy, American Society for Radiation Oncology, MRD, MD, Annual general meeting, HPV, AM, Neoplasm, Recurrence, Society, Neck, Vaccine, Raoul de Navery

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.

Key Points: 
  • 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.
  • The company will also highlight its TTMV-DNA platform in abstracts selected for oral presentation at both meetings.
  • “There is growing enthusiasm for the use of NavDx in daily practice across the continuum of HPV-driven OPSCC care, especially in the surveillance setting,” said Barry M. Berger, MD, Chief Medical Officer of Naveris.
  • Naveris and NavDx will be on exhibit at AAO-HNSF 2023 at Booth #608 and at ASTRO 2023 at Booth #3325.

Mayo Clinic Collaborates with Naveris to Advance Precision Medicine in HPV-driven Head and Neck Cancer with NavDx in DART 2.0 Clinical Trial

Retrieved on: 
Wednesday, April 12, 2023
Oncology, Health, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, TTMV, Mayo Clinic, College, Progression-free survival, ASTRO, Clinical trial, Cancer, Head, College of American Pathologists, MRD, DART, CLIA, Patient, Physician, Risk, Disease, Recurrence, III, Vaccine, Pharmaceutical industry, Raoul de Navery

Naveris, Inc., a leader in molecular diagnostics for viral cancers, today announced the launch of the DART 2.0 prospective clinical trial (NCT05541016) by Mayo Clinic.

Key Points: 
  • Naveris, Inc., a leader in molecular diagnostics for viral cancers, today 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.
  • "This clinical trial represents a significant step forward in personalized medicine for head and neck cancer patients," said Piyush B. Gupta PhD, Founder and CEO of Naveris.
  • DART 2.0 builds upon the results of the previously reported phase III MC1675 DART clinical trial, where NavDx-detected molecular residual disease (MRD) was a significant risk factor for cancer recurrence in patients with head and neck cancer.

Naveris Collaborators Present Award-winning Abstract at ASTRO 2022 on Potential of NavDx to Inform Treatment Strategies in HPV-driven Cancers

Retrieved on: 
Monday, October 24, 2022
Biotechnology, Health, Oncology, LinkedIn, Papilloma, CLIA, College of American Pathologists, Risk, Mayo Clinic, Disease, American Society for Radiation Oncology, Head, Radiation, DART, TTMV, List of pathologists, Society, Patient, Biotechnology, Twitter, Annual general meeting, Cancer, III, DRS, MRD, Radiation therapy, ASTRO, Progression-free survival, Toxicity, CEO, College, Recurrence, HPV, OPSCC, DNA, Medical imaging, Pharmaceutical industry, Vaccine, Raoul de Navery

radiation oncologist, Mayo Clinic, and first author of the study, was honored with the ASTRO Basic/Translational Science Award for this work.

Key Points: 
  • radiation oncologist, Mayo Clinic, and first author of the study, was honored with the ASTRO Basic/Translational Science Award for this work.
  • The presence of MRD, both in the post-operative setting and at 3 months post-treatment, was significantly associated with shorter progression-free survival.
  • Results from the MC1675 trial were initially presented at the ASTRO 2021 annual meeting and follow-up is ongoing.
  • More information on Naveris and NavDx can be found at booth #2348, or look for highlights from #ASTRO22 Twitter and LinkedIn .

Naveris Announces Abstract Accepted for Presentation at the 2022 American Society for Clinical Oncology (ASCO) Annual Meeting

Retrieved on: 
Friday, June 3, 2022
Oncology, Health, General Health, Research, Science, Pharmaceutical, Biotechnology, Head, EDT, Physical Sciences-Oncology Centers, Society, Plasma, ASCO, TTMV, IMRT, Annual general meeting, Cisplatin, Physician, American Society of Clinical Oncology, Patient, Risk, Head and neck cancer, HPV, Association, Vaccine, Medical imaging, Raoul de Navery

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.

Key Points: 
  • 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.
  • The company applies its innovative and patented technology to develop molecular diagnostics which enable earlier detection of viral cancers.
  • Naveris' first commercial-stage diagnostic, NavDx, is a blood test that supports the clinical management of patients with HPV-driven cancers.

Naveris’ Head and Neck Cancer Recurrence Detection Study Selected for Presentation at ASTRO 2022 Plenary Session

Retrieved on: 
Thursday, February 24, 2022
Oncology, Health, Other Science, Research, Science, Biotechnology, Risk, ASTRO, Literature, Physician, Head, Doctor of Philosophy, Toxicity, TTMV, Cancer, Recurrence, EST, Patient, MST, Biopsy, HPV, MD, Vaccine

Naveris, Inc., a leader in molecular diagnostics for viral cancers, today 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.

Key Points: 
  • Naveris, Inc., a leader in molecular diagnostics for viral cancers, today 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.
  • NavDx has fundamentally transformed, for the better, how patients treated for HPV-driven cancers are surveilled for the development of recurrence, said Naveris CEO Piyush Gupta, PhD.
  • The Multidisciplinary Head and Neck Cancers Symposium provides the most up-to-date information on multidisciplinary therapies, clinical research, treatment strategies, supportive care, scientific breakthroughs, and toxicity mitigation for the entire head and neck cancer community.
  • Naveris' first commercial-stage diagnostic, NavDx, is a blood test that supports the clinical management of patients with HPV-driven cancers.