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Natera Receives Final Medicare Coverage for its Signatera™ MRD Test in Stage II-III Colorectal Cancer


Natera Receives Final Medicare Coverage for its Signatera™ MRD Test in Stage II-III Colorectal Cancer

Creates patient access to first-of-its-kind, personalized ctDNA test to inform adjuvant treatment decisions and detect recurrence earlier than standard diagnostic tools

On Sept. 3, 2020 CMS Molecular Diagnostics Program (MOLDX) 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). The final LCD is posted here and the billing and coding article here on the Centers for Medicare and Medicaid Services website.

The final LCD covers 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.


  1. Reinert T, Henriksen TV, Christensen E, et al. Analysis of plasma cell-free DNA by ultradeep sequencing in patients with stages I to III colorectal cancer. JAMA Oncol. 2019;5(8):1124–1131.
  2. Coombes RC, Page K, Salari R, et al. Personalized detection of circulating tumor DNA antedates breast cancer metastatic recurrence. Clin Cancer Res. 2019;25(14):4255-426.
  3. Abbosh C, Birkbak NJ, Wilson GA, et al. Phylogenetic ctDNA analysis depicts early-stage lung cancer evolution. Nature. 2017;545(7655):446-451.
  4. Christensen E, Birkenskamp-Demtroder K, Sethi H, et al. Early detection of metastatic relapse and monitoring of therapeutic efficacy by ultra-deep sequencing of plasma cell-free DNA in patients with urothelial bladder carcinoma. J Clin Oncol. 2019; 37(18):1547-1557.
  5. Bratman SV, Yang SYC, Iafolla MAJ, et al. Personalized circulating tumor DNA analysis as a predictive biomarker in solid tumor patients treated with pembrolizumab. Nat. Cancer. 2020.
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