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

WALTHAM, Mass.--(BUSINESS WIRE)-- 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.

“We commend CMS’s rigorous approach to diagnostic test coverage and reimbursement, which has been crucial for making life-saving technologies like NavDx broadly accessible to patients suffering from cancer,” said Piyush B. Gupta, PhD, Founder, Executive Chairman, and Chief Science and Technology Officer of Naveris. “This ADLT designation, along with Medicare coverage for NavDx, expands beneficiary access to earlier detection and treatment of cancer, improving patient care and outcomes.”

NavDx is the first and only clinically validated circulating TTMV-HPV DNA blood test. It provides a non-invasive and precise method for detecting HPV-driven cancers before there is clinical or radiographical evidence of disease. Data supporting the clinical validity and utility of NavDx has been published in nearly 20 peer-reviewed publications. Approval of new ADLT status for NavDx as described by CPT® code 0356U is effective as of April 1, 2024.

“Receiving ADLT designation for the NavDx test is an exciting next step for Naveris and confirms the unique clinical information provided by NavDx and our TTMV platform,” said James McNally, Chief Executive Officer of Naveris. “This is a major milestone in the growth of our company and demonstrates our commitment to improving patient access to precision medicine tools for HPV-related cancer surveillance.”

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).

View source version on businesswire.com: https://www.businesswire.com/news/home/20240321303702/en/