Medicare Publishes Final Local Coverage Determination for Pan-Cancer Immunotherapy Monitoring with Natera's Signatera? MRD Test
November 11, 2021 at 11:52 am EST
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Natera, Inc. announced that the CMS Molecular Diagnostics Services Program (MolDX) has issued a final local coverage determination (LCD) for pan-cancer immunotherapy monitoring using its Signatera molecular residual disease (MRD) test. An accompanying Billing and Coding Article, linked here, specifies that serial testing with Signatera is now covered for Medicare patients being treated with immunotherapy, regardless of tumor type. The final LCD is consistent with the draft posted in September 2020, also establishing an accelerated pathway to Signatera coverage in new testing indications.
Natera, Inc. is a diagnostics company, which is focused on the development and commercialization of molecular testing services, applying its technology in the fields of womenâs health, oncology and organ health. Its cell-free deoxyribonucleic acid (cfDNA) technology combines its molecular assays, which reliably measure many informative regions across the genome from samples as small as a single cell. The Company's product offerings include Panorama Non-Invasive Prenatal Test (NIPT), Vistara, Horizon Carrier Screening, Spectrum Preimplantation Genetics, Anora Miscarriage Test, Empower, and Prospera. The Company also offers Constellation, a cloud-based software platform that enables laboratory customers to gain access through the cloud to the Companyâs algorithms and bioinformatics in order to validate and launch tests based on the Companyâs technology. Its NIPT screens for chromosomal abnormalities of a fetus as well as in twin pregnancies, typically with a blood draw from the mother.