The Centers for Medicare & Medicaid Services (CMS) has granted Advanced Diagnostic Laboratory Test (ADLT) status for the Signatera molecular residual disease (MRD) test from Austin, Texas-based Natera, Inc.

Obtaining ADLT status confirms that Signatera meets the highly selective criteria established under the Protecting Access to Medicare Act of 2014 (PAMA). The initial ADLT rate established by CMS is $3,500 for each Signatera assay used in the recurrence monitoring setting. Signatera received Medicare coverage for use in stage II-III colorectal cancer in late 2020, while finalization of a draft local coverage determination for use in immunotherapy response monitoring is anticipated for release in late 2021.

“Receiving ADLT status represents a major milestone in our commercialization efforts and confirms the unique nature of the Signatera assay,” says John Fesko, chief business officer at Natera. “We are committed to working closely with CMS to expand access to MRD testing to ensure CMS members, physicians, and healthcare systems can fully benefit from this revolutionary technology.”

Signatera is used for treatment monitoring and MRD assessment and can detect cancer recurrence up to two years before conventional imaging. To date, Signatera has been studied in over 3,000 patients and in 12 peer-reviewed publications, including multi-site, prospective, randomized trials, across more than 25 different tumor types. The test has also been granted three Breakthrough Device Designations by the FDA.