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.'"