Natera on Thursday announced the first commercial coverage policies for its molecular residual disease test, Signatera, including its first pan-cancer coverage policy for adjuvant, recurrence monitoring and treatment monitoring.
Effective March 1, Blue Shield of California began providing coverage of Signatera for plan members diagnosed with solid tumors.
Specifically, the policy describes tumor-informed ctDNA testing with Signatera as medically necessary for patients with stages I-IV cancer. The testing provides information for adjuvant or targeted therapy and/or monitoring for relapse or progression, including but not limited to the use of immunotherapy.
In addition, effective January 1, 2023, Blue Cross and Blue Shield of Louisiana is providing coverage of serial testing with Signatera for plan members diagnosed with colorectal and muscle invasive bladder cancer and for pan-cancer immunotherapy monitoring.
“Following the recent breast cancer coverage decision by Medicare, achieving our first commercial coverage policies for Signatera -- including one that encompasses pan-cancer coverage -- is another major milestone for Natera and the patients who will now have enhanced access to tumor-informed ctDNA testing,” John Fesko, chief business officer, said in a statement. “These developments underscore the medical necessity of Signatera to inform critical treatment decisions and detect recurrence earlier.”
Signatera is a custom-built circulating tumor DNA (ctDNA) test for treatment monitoring and molecular residual disease (MRD) assessment in patients previously diagnosed with cancer. The test is available for both clinical and research use, and has been granted three breakthrough device designations by the U.S. Food and Drug Administration (FDA) for multiple cancer types and indications.