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CMS Designates NavDx Test for HPV-Driven Cancer as ADLT

NEW YORK – Precision oncology diagnostics firm Naveris announced on Thursday that the US Centers for Medicare and Medicaid Services has designated its NavDx blood test as an Advanced Diagnostic Laboratory Test (ADLT). 

The test received Medicare coverage last year for assessing molecular residual disease in patients with a history of HPV-driven head and neck cancer, the company said in a statement. Approval of ADLT status for NavDx is effective April 1. 

The ADLT designation in combination with Medicare coverage "expands beneficiary access to earlier detection and treatment of cancer, improving patient care and outcomes," Piyush Gupta, founder, executive chairman, and chief science and technology officer at Naveris, said in a statement. 

ADLTs are a category of tests created under the Protecting Access to Medicare Act in response to lab concerns about what they considered low proposed crosswalk prices for certain assays. They use a unique algorithm to assess a panel of DNA, RNA, or protein markers, or a US Food and Drug Administration-approved or -cleared test. ADLTs refer to tests that are developed and performed at a single lab. 

Naveris' liquid biopsy test was commercially launched in 2021 and quantifies fragments of circulating tumor tissue-modified viral HPV DNA in a blood sample.