AUSTIN, Texas - Natera, Inc. (NASDAQ: NASDAQ:NTRA), a pioneer in cell-free DNA testing, announced that its Signatera test has gained additional coverage under the Centers for Medicare & Medicaid Services (CMS) for two new cancer indications.
The Molecular Diagnostics Services Program (MolDX) now includes ovarian cancer for adjuvant and surveillance settings, as well as breast cancer in the neoadjuvant setting.
This expansion builds on the existing Medicare coverage for Signatera, which already includes colorectal cancer, muscle-invasive bladder cancer, and breast cancer for adjuvant and recurrence monitoring, along with pan-cancer immunotherapy response monitoring.
The MolDX coverage for ovarian cancer applies to patients in both adjuvant and surveillance settings. Ovarian cancer is the fifth leading cause of cancer-related death among women in the United States, with a median age at diagnosis of 63 years.
The Signatera test's performance in ovarian cancer was validated in a study that showed 100% sensitivity and specificity in detecting recurrence, with an average lead time of 10 months ahead of imaging.
For breast cancer patients undergoing neoadjuvant therapy, the expanded coverage now includes all subtypes of the disease. A study published in Cancer Cell demonstrated that early circulating tumor DNA (ctDNA) clearance during neoadjuvant therapy was a significant predictor of therapy response, with Signatera negativity after such therapy being significantly associated with improved distant recurrence-free survival.
Minetta Liu, M.D., chief medical officer of oncology at Natera, stated that these Medicare decisions underscore the company's ability to personalize disease management for patients, particularly for ovarian cancer, the most lethal gynecologic malignancy. She emphasized that clinical evidence supports the value of Signatera across various settings, which can aid clinicians in making timely decisions and potentially improve patient outcomes.
Signatera is a personalized, tumor-informed MRD test designed to detect and quantify residual cancer in patients previously diagnosed with cancer. The test is tailored for each individual and uses ctDNA to identify recurrence earlier than standard care tools, thereby helping optimize treatment decisions. It is clinically validated across multiple cancer types and indications, with over 65 peer-reviewed papers supporting its use.
The information for this article is based on a press release statement from Natera, Inc.
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