Medicare Coverage For Natera's Signatera For Pan-Cancer Immunotherapy Monitoring

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  • CMS Molecular Diagnostics Services Program (MolDX) has issued a final local coverage determination (LCD) for pan-cancer immunotherapy monitoring using Natera Inc's NTRA Signatera molecular residual disease (MRD) test. 
  • An accompanying Billing and Coding Article specifies that serial testing with Signatera is now covered for Medicare patients being treated with immunotherapy, regardless of tumor type. 
  • The final LCD for immunotherapy monitoring is the second Medicare LCD covering Signatera (the first was in early-stage colorectal cancer).
  • But it is the first covering Signatera for pan-cancer use in any patient where immunotherapy is indicated.
  • 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. 
  • Price Action: NTRA shares are up 3.70% at $110.96 during the market session on the last check Thursday.
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