Natera launches Signatera Genome assay nationwide

AUSTIN, Texas - Natera, Inc. (NASDAQ: NTRA), a pioneer in cell-free DNA testing with a market capitalization of $20.08 billion, has announced the U.S. launch of its Signatera Genome assay, an ultra-sensitive test designed to detect circulating tumor DNA (ctDNA) for cancer management. The company has demonstrated impressive growth, with revenue increasing by 56.75% over the last twelve months and maintaining a healthy gross profit margin of 60.3%. According to InvestingPro analysis, Natera maintains strong financial health with a current ratio of 4.0, indicating robust liquidity. The company’s announcement coincides with the acceptance of its large-scale clinical study for presentation at the American Society of Clinical Oncology (ASCO) Annual Meeting on a date earlier than April 17, 2025.

The study encompasses over 3,000 plasma samples from various cancer types, including breast, colorectal, non-small cell lung cancer, melanoma, and renal cell carcinoma. Findings indicate that the Signatera Genome assay can detect ctDNA significantly before clinical recurrence, with robust performance metrics. This clinical advancement has contributed to Natera’s strong market performance, with the stock delivering a 62.36% return over the past year. InvestingPro data reveals 8 additional key insights about Natera’s growth trajectory and market position. Moreover, the study revealed that patients with postsurgical ctDNA detected by Signatera experienced shorter recurrence-free survival compared to those without detectable ctDNA.

Signatera Genome leverages Natera’s patented multiplex polymerase chain reaction and next-generation sequencing technology to identify minute traces of tumor DNA at levels as low as 1 part per million. The test is personalized, using whole genome sequencing of a patient’s tumor and matched normal DNA to design a bespoke assay.

Alexey Aleshin, M.D., Natera’s general manager of oncology and corporate chief medical officer, expressed satisfaction with the evidence supporting Signatera Genome’s ultra-sensitive MRD detection capabilities, which he believes will be a valuable tool for physicians.

Signatera is a molecular residual disease test tailored to each cancer patient, using ctDNA to detect and quantify residual cancer, aiming to identify recurrence earlier and aid in optimizing treatment decisions. The test has Medicare coverage for a wide range of indications and is supported by over 100 peer-reviewed publications.

Natera is a global leader in genetic testing, focusing on oncology, women’s health, and organ health. The company operates laboratories in Austin, Texas, and San Carlos, California, which are ISO 13485-certified, CAP-accredited, and CLIA-certified. While the company’s current valuation appears to be trading above its Fair Value according to InvestingPro models, investors can access a comprehensive Pro Research Report, available exclusively to subscribers, which provides detailed analysis of Natera’s growth prospects and market position among 1,400+ top US stocks.

The information in this article is based on a press release statement from Natera, Inc. The company cautions that the forward-looking statements within the release are subject to risks and uncertainties that may cause actual results to differ materially from those projected.

In other recent news, Natera Inc. reported its fourth-quarter 2024 earnings, exceeding Wall Street expectations with a revenue of $476 million, which marks a 53% year-over-year increase. The company’s gross margins improved to 63%, up from 51% the previous year, and they generated $46 million in cash flow during the quarter. Despite these strong financial results, Natera’s stock was downgraded by market reactions, though analysts at TD Cowen and Canaccord Genuity maintained a Buy rating, setting a price target of $195. Canaccord Genuity raised its target from a previous $180, following Natera’s fourth-quarter results that surpassed initial estimates. The company is also conducting the HEROES clinical trial in France, aiming to explore treatment de-escalation in metastatic HER2+ breast cancer patients. Furthermore, Natera received positive feedback on its guidance for 2025, projecting a revenue growth of 24% at the midpoint. Analyst firms highlighted Natera’s strategic operational expenditures and potential for increased sales as factors supporting the company’s promising outlook.

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