Naveris Introduces Advanced NavDx+Gyn™ Test for Early Detection of HPV-Driven Gynecologic Cancers

WALTHAM, Mass.--(BUSINESS WIRE)--Naveris, Inc., the leader in precision oncology diagnostics for viral-induced cancers, 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.

Leveraging the robust foundation of the NavDx test, which has been validated in over 35 peer-reviewed publications and utilized in nearly 100,000 patient-physician encounters, NavDx+Gyn expands detection capabilities to include fourteen high-risk HPV types associated with cervical, vaginal, and vulvar cancers. This new blood test has been rigorously validated to provide exceptional analytical specificity and sensitivity, setting a new standard for early detection and monitoring of these cancers.

The analytical validation, published in the Journal Diagnostics, confirms that NavDx+Gyn achieves outstanding limits of detection and quantitation, ensuring dependable detection of HPV types at very low concentrations. The assay's performance was extensively tested across multiple analytical metrics including accuracy, precision, and linearity, with results underscoring its high-quality standards.

"NavDx+Gyn is a significant enhancement in the non-invasive surveillance of HPV-associated gynecologic cancers," said Dr. Piyush B. Gupta, PhD, Executive Chairman, Chief Science & Technology Officer, and Founder of Naveris. "Early detection is vital for effective management and treatment of these cancers."

The development of NavDx+Gyn comes at a critical time, addressing the pressing need for advanced diagnostic tools in the face of the global burden of HPV-related cancers and the limitations of current diagnostic methods. By offering a reliable, non-invasive testing option, NavDx+Gyn aims to change the landscape of cancer surveillance and offer new hope to thousands of women worldwide.

"Naveris is committed to advancing healthcare equity and improving outcomes for cancer patients through state-of-the-art diagnostics," added Dr. Barry M. Berger, MD, Chief Medical Officer of Naveris. "NavDx+Gyn embodies our dedication to harnessing innovation to improve patient care through early detection.”

Hutcheson J., Conway D., Kumar S., Wiseman C., Chakraborty S., Skrypkin E., Horan M., Gunning A., Williams C.K., Kuperwasser C., Naber S.P., and Gupta P.B. Analytical Validation of NavDx+Gyn, a cfDNA-Based Fragmentomic Profiling Assay for HPV-Driven Gynecologic Cancers. Diagnostics 2025, 15(7), 825. https://www.mdpi.com/2075-4418/15/7/825

About Naveris

Naveris is a privately held, commercial stage, precision oncology diagnostics company with facilities in Massachusetts and North Carolina. Since its founding in 2017, Naveris has been committed to improving outcomes for the millions of people at risk of developing viral-induced cancers with 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).