© Reuters.
AUSTIN, Texas – Natera, Inc. announced (NASDAQ: NTRA), a leader in cell-free DNA testing, announced that its Signatera test has received additional coverage from the Centers for Medicare & Medicaid Services (CMS) for two new cancer indications.
The Molecular Diagnostic Services (MolDX) program now includes ovarian cancer in adjuvant and surveillance settings, as well as breast cancer in the neoadjuvant setting.
This expansion builds on existing Medicare coverage for Signatera, which already includes colorectal cancer, muscle-invasive bladder cancer, and breast cancer in the adjuvant setting and for monitoring recurrence, as well as monitoring response to systemic cancer immunotherapy.
MolDX coverage for ovarian cancer applies to patients in adjuvant and observational settings. Ovarian cancer is the fifth leading cause of cancer death among women in the United States, with the average age at diagnosis being 63 years.
The performance of the Signatera test in ovarian cancer was validated in a study that demonstrated 100% sensitivity and specificity in detecting disease recurrence, with a median delay of 10 months before imaging.
For breast cancer patients undergoing neoadjuvant therapy, expanded coverage now includes all disease subtypes. A study published in the journal Cancer Cell showed that early clearance of tumor DNA (ctDNA) during neoadjuvant therapy was an important predictor of response to treatment, with Signatera negativity after such treatment significantly associated with a significant improvement in distant recurrence-free survival.
These clinical care decisions highlight the company's ability to personalize disease management for patients, especially ovarian cancer, the deadliest gynecologic malignancy, said Mineta Liu, M.D., medical director of Natera's oncology division. She noted that clinical data supports the value of Signatera in a variety of settings, which can help doctors make timely decisions and potentially improve patient outcomes.
Signatera is a personalized tumor-based MRD test designed to detect and measure residual cancer in patients previously diagnosed with cancer. The test is tailored to each individual and uses ctDNA to identify disease recurrence earlier than standard of care tools, helping to improve treatment decisions. It has been clinically validated for multiple cancer types and indications, with over 65 peer-reviewed articles supporting its use.
The information in this article is based on a press release issued by Natera, Inc.
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