Medicare Extends Coverage of Natera’s Signatera MRD Test to Ovarian Cancer and Neoadjuvant Breast Cancer

Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA testing, today announced that its personalized and tumor-informed molecular residual disease (MRD) test, Signatera, has met coverage requirements from the Centers for Medicare & Medicaid Services’ (CMS) Molecular Diagnostics Services Program (MolDX) in two new indications: ovarian cancer in the adjuvant and surveillance settings, and breast cancer in the neoadjuvant setting.

These determinations add to a growing list of covered indications for Signatera, including adjuvant and recurrence monitoring coverage in colorectal cancer, muscle-invasive bladder cancer, and breast cancer; and pan-cancer immunotherapy response monitoring.

Ovarian Cancer

The MolDX coverage decision applies to patients with ovarian cancer, in both the adjuvant and surveillance settings.

Ovarian cancer is the 5^th leading cause of cancer-related death among women, with an estimated 2022 incidence and mortality of 19,880 and 12,810, respectively, and a median age at diagnosis of 63 years.¹ While multiple new treatment options have been introduced in recent years, physicians have had to rely on imperfect biomarkers to determine who is likely to benefit from these more intensive regimens, and recurrence risk remains high². Additionally, current guidelines for surveillance are limited and providers often rely on tools with low sensitivity and specificity, such that a significant unmet need remains for these patients.³

Signatera performance in ovarian cancer was validated in a blinded, multi-site study published in Gynecologic Oncology.⁴ The study analyzed 163 plasma samples from 69 patients with stage I-IV ovarian cancer. Test performance was evaluated at multiple time points: pre-surgery, post-surgery prior to adjuvant treatment, and longitudinally. With longitudinal testing, recurrence was detected with 100% sensitivity, 100% specificity, and an average lead time of 10 months ahead of imaging.

Breast Cancer (neoadjuvant setting)

This MolDx coverage decision 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.

Up to 50% of newly diagnosed breast cancer patients receive neoadjuvant therapy (NAT).⁵ Guidelines recommend routine assessment of tumor response to neoadjuvant therapy but acknowledge that this is “difficult” using currently available diagnostic tools.⁶ Signatera has been validated to address this unmet need.