WALTHAM, Mass.--(BUSINESS WIRE)--Naveris, Inc., the leader in precision oncology diagnostics for viral-induced cancers, today 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.
The NavDx test provides a non-invasive and precise method that aids in the detection of 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, leading to recent positive Medicare and commercial insurance coverage policies.
Empowering Physicians and Patients Through Real-World Data
Building on this strong and growing clinical evidence base, the NAVigate-HPV Registry will enrich understanding of HPV-driven cancers while fostering a collaborative ecosystem where physicians and patients contribute to the evolution of cancer care.
"The NAVigate-HPV Registry will act as a catalyst for the development of personalized approaches for the treatment and management of patients with HPV-driven cancers," said Dr. Adam Raben, MD, Chair of Radiation Oncology at ChristianaCare and the Helen F. Graham Cancer Center & Research Institute, and a member of the NAVigate-HPV Registry Steering Committee. "By integrating real-world data from across the United States, the registry will unlock additional clinical insights potentially leading to a better understanding of disease behavior, new treatment options, and ultimately improved outcomes for patients."
A Testament to Collaboration and Innovation
Participating investigators will include providers that order NavDx in their routine clinical practice. Eligible subjects must have or have had an HPV-driven cancer and have received at least one NavDx test. It is expected that the NAVigate-HPV Registry will encompass more than 1,000 patients within the first year and grow to more than 5,000 patients within five years.
“While the evidence supporting use of the NavDx test in surveillance is unambiguous, the addition of multi-institutional longitudinal data from the NAVigate-HPV Registry will advance our understanding of the test’s pivotal role in diagnosis, therapeutic decision making and overall disease management,” said Catherine Del Vecchio Fitz, PhD, SVP, Medical Affairs and Data Insights at Naveris. “As the leader in precision oncology diagnostics for viral-induced cancers, Naveris is well-positioned to support the creation of this registry. We are thankful to our collaborators who have made this registry a reality, and we look forward to unlocking new possibilities to positively impact patient care.”
About Naveris
Naveris is a privately held, commercial stage, precision oncology diagnostics company with facilities in Massachusetts and North Carolina. Naveris is dedicated to improving outcomes for the millions of people at risk of developing viral-induced cancers by developing novel molecular diagnostics that enable earlier cancer detection. The company operates high-complexity testing clinical laboratories that are accredited by the College of American Pathologists and the New York State Department of Health Wadsworth Center, and are certified under CLIA. For more information on Naveris and the clinical impact of NavDx, please visit www.naveris.com and www.NavDx.com. NavDx has not been cleared or approved by the US Food and Drug Administration (FDA).
