On March 2, 2023 Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA testing, reported the Company’s 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 (Press release, Natera, MAR 2, 2023, View Source [SID1234628103]).
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Effective March 1, 2023, Blue Shield of California now provides commercial coverage of Signatera for plan members diagnosed with any solid tumors. Specifically, the policy describes tumor-informed ctDNA testing with Signatera as medically necessary for patients with stage I-IV cancer to provide information for (1) adjuvant or targeted therapy; and/or (2) 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," said John Fesko, chief business officer. "These developments underscore the medical necessity of Signatera to inform critical treatment decisions and detect recurrence earlier."
Data supporting the clinical validity and utility of Signatera has been published in approximately 40 peer-reviewed publications, including validation across multiple cancer types to detect recurrence earlier than standard diagnostic tools1,2 and to improve the assessment of treatment response in conjunction with imaging.3
About Signatera
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 FDA for multiple cancer types and indications. The Signatera test is personalized and tumor-informed, providing each individual with a customized blood test tailored to fit the unique signature of clonal mutations found in that individual’s tumor. Signatera is intended to detect and quantify cancer left in the body, at levels down to a single tumor molecule in a tube of blood, to identify recurrence earlier and to help optimize treatment decisions.