COMPANY:

Naveris

"Naveris, Inc...today announced the analytical validation of NavDx+Gyn, an important extension of the NavDx® blood test. NavDx+Gyn is a cell-free DNA-based fragmentomic profiling assay that enhances the detection and monitoring of human papillomavirus (HPV)-driven gynecologic cancers."

"Naveris, Inc...announced the expanded commercial availability of the NavDx test for Molecular Residual Disease (MRD) detection in anal squamous cell carcinoma (ASCC) patients. NavDx, Naveris’ proprietary flagship blood test, is the first and only clinically validated circulating tumor TTMV-HPV DNA blood test that provides a non-invasive and precise method that can detect MRD before there is clinical or radiographic evidence of cancer recurrence...'With an impressive per-test positive predictive value (PPV) of 98% and a negative predictive value (NPV) of 95%, the NavDx test demonstrates exceptional clinical value in detecting and ruling out disease recurrence in ASCC patients.'....This new data further reinforces the clinical value of TTMV-HPV DNA testing in HPV-positive cancers, as supported by more than 30 peer reviewed publications validating use of the NavDx test in head and neck cancers."

"Naveris, Inc...announced that Blue Shield of California, an independent licensee of the Blue Cross Blue Shield Association, provides coverage as of July 1, 2024 for the NavDx® test, Naveris’ proprietary flagship blood test for Tumor Tissue Modified Viral (TTMV®)-HPV DNA."

"Naveris, Inc...announced the presentation of new data at the 66th Annual Meeting of the American Society for Radiation Oncology (ASTRO), taking place September 29 – October 2, 2024, in Washington, D.C...These presentations will showcase the role of the NavDx® test, the first and only clinically validated circulating Tumor Tissue Modified Viral (TTMV®)-HPV DNA blood test, in the management of HPV-driven oropharyngeal cancers, with a focus on integration into radiation oncology practices."

"Naveris, Inc...announces the publication of a significant study, 'Utility of TTMV-HPV DNA in resolving indeterminate findings during oropharyngeal cancer surveillance', in Oral Oncology. The study highlights the crucial role of Naveris' flagship product, the NavDx test, in enhancing diagnostic precision and clinical decision-making in surveillance of HPV-associated oropharyngeal cancer. The NavDx test is the first and only clinically validated circulating Tumor Tissue Modified Viral (TTMV®)-HPV DNA blood test."

"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."

"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."

"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."

"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."

"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."

"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."

"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.'"

"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."

"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."

"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."

"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."

"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."

"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."

"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."

"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."

"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."