Natera shared on X:
“Medicare coverage for Signatera just expanded to the most common type of liver cancer.
Signatera has met coverage requirements from the CMS MolDX program in hepatocellular carcinoma (HCC). The coverage includes serial testing in the surveillance setting for patients with early-stage HCC who have no post-surgical evidence of disease.
We’re pleased to share this news as clinical evidence continues to grow.
Read the full press release:”
Additional information about Signatera
- Signatera, developed by Natera, is a personalized circulating tumor DNA (ctDNA) blood test designed to detect molecular residual disease (MRD) and identify cancer recurrence earlier than standard monitoring tools.
- The test uses a tumor-informed approach, analyzing the unique mutation profile of each patient’s tumor to develop an individualized assay that tracks tumor-specific genetic alterations over time.
- Signatera uses ultra-deep sequencing, with coverage of up to 350,000× for selected variants, and tracks 64 carefully selected clonal variants to achieve high sensitivity and specificity. Its tumor-informed approach also helps filter out clonal hematopoiesis (CHIP)-related mutations.
- The test supports MRD assessment and recurrence monitoring across multiple solid tumors, including colorectal, breast, bladder, lung, and ovarian cancers. Natera reports an overall positive predictive value of more than 98% for predicting relapse across clinical studies.
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