NEW YORK – Natera said Thursday that the Centers for Medicare & Medicaid Services' MolDX program has determined that the firm's Signatera molecular residual disease test has met coverage requirements for adjuvant and recurrence monitoring in patients with stage IIb or higher breast cancer.
Shares of Natera surged on the news, rising as much as 16 percent to $49.15 in midmorning trading on the Nasdaq.
According to the company, the coverage applies across all subtypes of the disease, including HR-positive, HER2-positive, and triple-negative breast cancers.
Under a local coverage determination finalized by Medicare Administrative Contractor Palmetto GBA in 2021, any MRD test that successfully passes a technical assessment by MolDX and sufficiently demonstrates clinical validity and utility for its intended use case can gain coverage.
Natera has previously won CMS coverage for the use of Signatera in colorectal cancer, muscle-invasive bladder cancer, and pan-cancer immunotherapy monitoring.
The firm said the new breast cancer decision was primarily based on evidence from the Exploratory Breast Lead Interval Study, which demonstrated that Signatera could identify relapse with 89 percent sensitivity, 100 percent specificity, and a diagnostic lead time of up to two years ahead of radiographic imaging.
In a statement, Houston Methodist oncologist Jenny Chang called Signatera a "critical innovation."
"The five-year recurrence rates for breast cancer are estimated to be as high as 30 percent, and traditional methods for detecting recurrence can be inaccurate. Signatera addresses a critical unmet need," she added.
Minetta Liu, Natera's chief medical officer of oncology, called the CMS decision a "game changer for patients," not only for informing decisions related to active surveillance or treatment de-escalation but also for patients' peace of mind.