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Natera Signatera MRD Test Nabs Medicare Coverage for Ovarian, Neoadjuvant Breast Cancer

NEW YORK – Natera announced on Monday that the Centers for Medicare & Medicaid Services (CMS) will begin reimbursing its Signatera minimal residual disease (MRD) test in ovarian cancer in the adjuvant and surveillance settings and breast cancer in the neoadjuvant setting.

The Austin, Texas-based company said in a statement that Signatera MRD met coverage requirements from CMS's Molecular Diagnostic Services Program (MolDx), adding to a growing list of reimbursed indications for that assay including colorectal cancer, breast cancer, muscle invasive bladder cancer, and immunotherapy monitoring of solid tumors.

A clinical study of Signatera's performance in ovarian cancer in 163 plasma samples from 69 patients with stage I through stage IV ovarian cancer supported MolDx's decision in that indication.

The coverage decision for breast cancer was based on published clinical evidence from the I-SPY 2 trial, which featured clinical follow-up of 283 patients for a median of more than three years and a maximum of more than seven and a half years.

The extended breast cancer coverage applies to patients with breast cancer in the neoadjuvant setting across all subtypes of the disease, including hormone receptor (HR)-positive, HER2-positive, and triple-negative breast cancers.

Natera's Signatera MRD testing business comprised a significant part of the test volume growth underlying the company's 27 percent year-over-year rise in third quarter 2023 revenues.

MolDx determined that Signatera MRD met coverage requirements for adjuvant and recurrence monitoring in patients with stage IIb or higher breast cancer early last year.

"Clinical evidence continues to demonstrate the value of Signatera across various settings of disease, which can help clinicians make timely decisions and may improve outcomes for patients," Minetta Liu, chief medical officer of oncology at Natera, said in a statement. "We are incredibly proud of this milestone and look forward to continuing to work with Medicare to make Signatera more widely accessible for people affected by cancer."