Natera announced today that it received written confirmation from the Centers for Medicare & Medicaid Services (CMS) that its Signatera molecular residual disease (MRD) test will be reimbursed for adjuvant and recurrence monitoring in patients with stage IIb or higher breast cancer. The coverage is available across all subtypes including HR-positive, HR2-positive and triple-negative breast cancers.
“Signatera is a critical innovation that can help us to enhance care management for patients with breast cancer,” said Jenny C. Chang, MD, treating oncologist and director of the Houston Methodist Dr. Mary and Ron Neal Cancer Center. “The five-year recurrence rates for breast cancer are estimated to be as high as 30%, and traditional methods for detecting recurrence can be inaccurate. Signatera addresses a critical unmet need and improves our ability to accurately predict recurrence risk from breast cancer.”
The coverage decision, handed down by CMS’ Molecular Diagnostics Services Program (MolDX) adds to a growing list of covered indications for Signatera which includes colorectal cancer, muscle-invasive bladder cancer, and as a broad pan-cancer test for monitoring immunotherapy.
According to Natera, CMS based its decision to extend coverage to breast cancer indication based largely on a July 2019 study of Signatera published in Clinical Cancer Research. In that study, patients with all breast cancer subtypes were tested every six months after surgery to detect disease relapse. The study analyzed the circulating tumor DNA (ctDNA) 208 blood samples from 49 patients monitored longitudinally for up to four years after completion of adjuvant chemotherapy to determine
Employing Signatera, the research showed a diagnostic lead time of relapse of as much as two years—with a median time of 8.9 months—ahead of detection using radiographic imaging, with 89% sensitivity and 100% specificity.
“Extending Medicare coverage for Signatera to patients with breast cancer, irrespective of subtype, is a real milestone for precision oncology and a game changer for patients,” said Minetta Liu, MD, chief medical officer of oncology at Natera. “Our tumor-informed assay enables oncologists to more confidently identify patients at high risk of recurrence, informing decisions related to active surveillance via imaging, as well as decisions to escalate or de-escalate treatment.”
Signatera, which has received Breakthrough Device Designations from the FDA for multiple cancer types and indications, employs a customized design process for patients using information about the somatic variants of each person’s cancer based on testing of their primary tumor. This tumor-informed approach, along with Natera’s proprietary detection technology, allows the test to detect and quantify cancer remaining in a patient’s body down to the single-molecule level. This allows for much earlier detection of recurrence and can help inform additional treatment decisions.