On September 3, 2020 Natera, Inc. (NASDAQ: NTRA), a pioneer and global leader in cell-free DNA testing, reported that the CMS Molecular Diagnostics Program (MOLDX) has finalized a local coverage determination (LCD) to provide Medicare benefits for serial use of the Signatera molecular residual disease (MRD) test in patients with stage II or III colorectal cancer (CRC) (Press release, Natera, SEP 3, 2020, View Source [SID1234564437]). The final LCD is posted here and the billing and coding article here on the Centers for Medicare and Medicaid Services website.
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The final LCD is consistent with Medicare’s draft posted in August of 2019, covering two intended uses: (1) Patient risk stratification after surgical resection, to inform adjuvant treatment decisions, and (2) Recurrence monitoring with the same frequency as CEA, in patients with a previous cancer diagnosis but no ongoing evidence of disease. The LCD cites several published studies in its summary of evidence including one study showing Signatera’s ability to detect CRC recurrence up to 16.5 months earlier than imaging and CEA (average 8.7 months earlier).1
"Colorectal cancer remains one of the deadliest forms of cancer, but it’s also relatively unique as a disease where early detection of relapse is known to improve outcomes," said Scott Kopetz, MD, PhD, oncologist and professor, Department of Gastrointestinal (GI) Medical Oncology, The University of Texas MD Anderson Cancer Center, and Principal Investigator of Natera’s BESPOKE CRC study. "There is ample evidence suggesting that circulating tumor DNA will enable earlier relapse detection and improved decision-making in the adjuvant setting, and I look forward to seeing it used more in clinical practice."
Signatera has been validated across multiple cancer types to detect residual disease up to 2 years earlier than standard diagnostic tools, with virtually no false positives on a per sample level,1-4 and to help assess treatment response in conjunction with imaging.5 While a negative test result does not mean someone is definitely cancer-free, it does mean the risks of relapse or disease progression are significantly reduced.
"Medicare coverage marks a significant milestone in our mission to transform cancer care," said Solomon Moshkevich, General Manager of Natera’s oncology business. "This is the first covered indication for Signatera, with more in process as we continue to publish peer-reviewed studies supporting the validity of personalized ctDNA testing for treatment response monitoring and MRD assessment in multiple solid cancers."