Natera has received local coverage determination (LCD) from the U.S. Centers for Medicare and Medicaid Services for serial use of the Signatera molecular residual disease test in patients with colorectal cancer.
The LCD will be effective beginning on October 18, 2020, and applies to Medicare beneficiaries with current or prior stage II or stage III colorectal cancer. The future-effective coverage is consistent with Medicare's draft released in August 2019, the company noted.
The LCD coverage includes risk stratification of patients after surgical resection in order to make adjuvant treatment decisions. It also allows for recurrence monitoring for patients in remission with the same frequency as carcinoembryonic antigen (CEA) testing.
This is the first covered indication for Signatera, according to Natera staff. The company noted that the diagnostic can detect multiple types of residual cancer up to two years earlier than standard tests.