Natera Receives LCD From Palmetto for Signatera MRD Test in Colorectal Cancer Patients

Medicare Administrative Contractor Palmetto GBA released a final local coverage determination for ctDNA tests detecting minimal residual disease in patients with Stage II to Stage III colon cancer, focusing specifically on Natera’s Signatera test.

Limited coverage of minimal residual disease testing in cancer will be provided if the patient has advanced cancer, plans on being treated for said cancer, and has not previously been tested with the same test for the same genetic content; if the patient has a personal history of colorectal, the type and staging of which is within the intended use of the test; the identification of progression of disease within the intended use population of the test is identified in National Comprehensive Cancer Network guidelines as a condition requiring a definitive change in patient management; the test identifies recurrence or progression before there is clinical evidence and demonstrates sensitivity and specificity comparable with radiographical evidence; and the test completes a technical assessment to confirm analytical and clinical validity of the test. 

The policy is effective for services performed on or after Oct. 18. 

Source: https://www.genomeweb.com/regulatory-news-fda-approvals/natera-receives-lcd-palmetto-signatera-mrd-test-colorectal-cancer