Medicare expands coverage for Natera’s Signatera MRD test

Published 04/06/2025, 12:10
Medicare expands coverage for Natera’s Signatera MRD test

AUSTIN, Texas - Natera, Inc. (NASDAQ: NTRA), a pioneer in cell-free DNA testing and precision medicine, has announced that Medicare will now cover its Signatera MRD (molecular residual disease) assay for a wider range of cancers. The decision, effective under LCD L38779, includes Medicare beneficiaries with colorectal, breast, bladder, ovarian, and lung cancers, as well as patients undergoing pan-cancer immunotherapy monitoring. The company, currently valued at $21.87 billion, has demonstrated impressive revenue growth of 51.5% over the last twelve months, according to InvestingPro data.

This expanded coverage follows the presentation of a pan-cancer study involving 392 patients at the recent 2025 American Society of Clinical Oncology (ASCO) Annual Meeting earlier this week. The study highlighted the clinical utility of the Signatera Genome assay, which utilizes Natera’s proprietary multiplex PCR-NGS technology for deep sequencing of targeted high-quality variants. While the stock has shown significant volatility, it has delivered a robust 51.17% return over the past year.

Matthew Mega, senior vice president of market access at Natera, expressed satisfaction with Medicare’s decision, stating it reflects the clinical, analytical, and clinical validity of the Signatera assay. The coverage ensures that Medicare patients have broader access to the latest advancements in Natera’s MRD product portfolio.

Signatera is a personalized, tumor-informed test that uses circulating tumor DNA to detect and quantify residual cancer, allowing for earlier detection of recurrence and aiding in treatment decision-making. The test has been validated through over 100 peer-reviewed studies across various cancer types and indications.

Natera is recognized for its expertise in genetic testing and diagnostics in oncology, women’s health, and organ health, with a commitment to integrating personalized genetic testing into standard care. The company operates laboratories in Austin, Texas, and San Carlos, California, which are ISO 13485-certified and CAP-accredited, as well as CLIA-certified.

The information in this article is based on a press release statement from Natera, Inc. For deeper insights into Natera’s financial health, growth prospects, and comprehensive analysis, access the full InvestingPro Research Report, which includes detailed metrics, expert analysis, and future growth projections. The company maintains strong liquidity with a current ratio of 3.87, indicating robust financial stability despite current market challenges.

In other recent news, Natera reported impressive financial results for Q1 2025, surpassing earnings per share expectations with an EPS of -$0.50 compared to the forecast of -$0.64. The company’s revenue reached $522 million, reflecting a 37% increase year-over-year. Following these robust earnings, Natera raised its full-year revenue guidance to between $1.94 billion and $2.02 billion. RBC Capital Markets maintained an Outperform rating on Natera, with a price target of $251, highlighting the company’s strong quarterly performance and promising pipeline. TD Cowen also expressed optimism, raising the price target for Natera to $200 and noting the company’s 13% higher-than-expected sales, driven by a 5% increase in core sales and favorable prior period developments. Natera’s Signatera product saw clinical volumes rise significantly, with a 52% year-over-year increase, indicating strong market reception. Additionally, Natera’s gross margins exceeded expectations, suggesting effective operational performance. These developments underscore Natera’s strategic focus on innovation and market expansion, particularly in the oncology segment.

This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.

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